**Curriculum Vitae**

**Name:** ADITYA SHETTY
**Father’s Name:** Shridhar
**Address:** 2/21 Jyothi Nilaya, Ranganakere, Herady post, Udupi District and Taluk – 576210

**Objective:**
Dynamic and result oriented M.Sc. Biotechnology student with a passion for scientific inquiry and data-driven decision-making. Equipped with a robust foundation in Genomic analysis, Computer Aided Drug Design (CADD), Biochemical assays, Molecular and Pharmacological techniques. Seeking a challenging opportunity in the fields of clinical research, pharmacogenomics, and Quality management within the pharmaceutical industry. Eager to leverage academic background, practical skills, and ongoing pursuit of advanced training in clinical research to contribute to innovative research projects. Eager to learn new skill set to enhance industrial growth in the field of Quality Management. Committed to expanding knowledge and expertise in these areas while making meaningful contributions to the advancement of healthcare.

**Educational Qualification:**

**Qualification** | **Specialization** | **Year** | **Institutes** | **University** | **Percentage/CGPA**
—|—|—|—|—|—
Master Of Science | Biotechnology | 2024 | Bioscience Block, Kuvempu University, Jnanasahyadri, Shankarghatta, Shivamogga-577451 | Kuvempu University | 7.48
Bachelor Of Science | CBZ | 2022 | DVS Arts and Science College, Shivamogga-577201 | Kuvempu University | 86.87%
PUC | PCMB | 2019 | SDPT PU College, Mandarthi, Udupi-576223 | Department of PreUniversity Education | 74.83%
SSLC | 2017 | Sri B V V Sanga Eng Med H S Vidyagiri, Bagalakote-587103 | Karnataka Secondary Education Board | 88.48%

**Work Experience:**
Working as a Data Scientist in Center for Integrative Omics Data Sciences (CIODS), Yenepoya, Mangaluru (From: 03/02/2025 – Present)

**Computer Knowledge:**
Proficient in basic computer operations, Microsoft Excel, and PowerPoint. Experienced in operating systems and Microsoft Windows. Well established in handling large data with Microsoft Excel. Well equipped with Drug designing tools and software, fast working and typing.

**Certifications and Training:**
– Presented a research paper entitled “Comparative Genome Studies of Streptococcus Pathogen Unveils a probable Vaccine Candidate” in the National Conference at JSS Academy of Higher Education and Research, Mysore.
– Attended the conference at 17th Kannada Vijnana Sammelana, Tumkur.
– Participated in a workshop on Computational Drug Discovery.
– Participated in Webinars on disease target identification using bioinformatics.
– Completed an internship at Yenepoya Research Centre (Cell Biology and Molecular Genetics), Mangaluru.

**Academic Knowledge:**
– Excellent communication skills in English, Kannada and Hindi.
– Proficient in presentation techniques.
– Skilled in both Wet and Dry Laboratory techniques in Biotechnology.
– Proficient in qualitative and quantitative analysis of proteins, DNA, RNA and Pharmacological aspects.
– Knowledgeable in immunological techniques, PCR, Gel electrophoresis, and flow cytometry.
– Familiar with microbial production processes and industrial upstream and downstream procedures.

**Technical Skills:**
**Dry Lab Skills**
– Handled a commercial molecular docking software “SeeSar 13.0.4”
– Undertook a small Bioinformatic project work on Streptococcus variant during the course lab.
– Genome analysis.
– Molecular Docking.

**Wet Lab Skills**
– **Biochemical Techniques:** Enzyme assay, Isolation of Biomolecules, PCR, ELISA and Western Blotting.
– **Phytochemistry:** Isolation of Phytocompounds, Qualitative and Quantitative estimation.
– **Plant Tissue Culture:** Cultured Habiscus lobatus invitro.
– **Small-scale Wine Production**, Culturing of Microbes, and maintenance.

**Instruments Handled:**
Laminar air flow, Autoclave, pH meter (precision), Double distillation unit, Ice flaker, Spectrophotometer (Thermo Scientific), Centrifuge (Beckman Coulter), Biosafety cabinet, PCR machine (Biorad), Western Blotting (Biorad), Soxhlet, Ultrasonicator, and Micropipets.

**Dissertation Work:**
– “Comparative genome studies of Streptococcus pathogen: Unveils a probable vaccine candidate”.
– “Molecular Docking Analysis of Bridged Heterocycle Quinolines as Potential RdRp Inhibitors of SARS-CoV Virus.

**Soft Skills:**
Good team player, Better Leadership qualities, Better Communication Skills, Quick learner, Work and Time management, Flexibility.

**Extracurricular Activities:**
Reading, travelling and playing cricket.

**Declaration:**
To serve the organization with which I associate at any point of time with the best of my knowledge and to keep on learning new concepts from which I can deliver my best work. I hereby declare that the Information furnished above is true to the best of my Knowledge.
Place: Ranganakere
Name: Aditya Shetty

**Skills:**
Biotechnology, Genomic Analysis, Computer Aided Drug Design, Biochemical Assays, Pharmacological Techniques, Clinical Research, Pharmacogenomics, Quality Management, Molecular Docking, DNA Analysis, PCR, Gel Electrophoresis, Drug Designing Tools, Research, Communication, Presentation, Leadership, Time Management, Flexibility.

Cover Letter:

I am Aditya Shetty and I am applying for the job role of Clinical Research Associate in your esteemed company. I got to know about the vacancy through LinkedIn. I have completed my Post Graduation in Biotechnology through Kuvempu University with good theoretical and subject knowledge. Most of my skills during course time is in Dry lab and I am interested in building my career in wet lab or clinical research roles. I am a good team player with good communication skills with proficiency in Kannada, Hindi and English languages. If given a chance I would like to enhance my skill set through your organization and will contribute as much as I can through my knowledge and time.

Thank you.

GAURAV ARYA

Personal Summary:

Gaurav Arya is a dedicated and highly skilled Biotechnology professional with a strong academic background and significant hands-on experience in Clinical Research. Seeking to leverage his expertise and passion for advancing medical research to contribute effectively to the industry.

Objective:

My aim is to gain the experience and practical knowledge to enrich my capabilities through exposure to industry. I am a person with high potential and punctual towards my duties. I want to have a professionally advanced career and good future. I have all the abilities and skills required.

Educational Qualifications:

M.Sc. (Biotechnology)
Vinoba Bhave University
Year of Passing: 2019
Semester I – 439/600, 7.6 SGPA
Semester II – 442/600, 8.0 SGPA
Semester III – 459/600, 8.1 SGPA
Semester IV – 567/700, 8.9 SGPA

B.Sc. (Biotechnology)
Vinoba Bhave University
Year of Passing: 2017
1527/2200, 70% (1st Division)

Intermediate
Sri Ramkrishna Mission
Year of Passing: 2013
344/500, 68% (1st Division)

Matriculation
St. Stephen’s School
Year of Passing: 2011
CGPA: 72%, 1st Division

Additional Qualifications:

1. Diploma in Food Quality Assessment & Food Safety
Vinoba Bhave University
Year of Passing: 2019
Semester I – 237/300, 8.33 SGPA
Semester II – 243/300, 8.33 SGPA

2. Diploma in Clinical Research (Professional Diploma in Clinical Research, PDCR) at Catalyst Clinical Services

Job Training:

• Completed job training in Blood Group Determination and Pathological Techniques at Patliputra Medical College and Hospital (PMCH), Dhanbad.
• Completed job training at Institute of Animal Health & Production, Ranchi.

Project Works:

• Project on the production of Biodiesel from different vegetable oils and its analysis at SHRM Biotechnologies Pvt. Ltd., Kolkata.
• Six-month project on anti-cancer activity of Ocimum sanctum (Tulsi) leaf extract against carcinoma cells at CSIR-IICB, Kolkata.

Work Experience:

• Clinical Research Coordinator in Surgical Oncology in Mahamana Pandit Madanmohan Malviya Cancer Centre/Homi Bhabha Cancer Hospital, BHU Campus, Varanasi.
• Project Assistant in School of Biotechnology, Jawaharlal Nehru University (JNU), New Delhi.
• Research Associate in Department of Oncology in V.V Biotech Pvt. Ltd., Sambodhi Retreat Bodhgaya, Bihar.

Special Achievements:

• Poster presentations in various scientific sessions and conferences.
• Published research paper in the World Journal of Pharmaceutical Research.

Personal Details:

Father’s Name: Sadanand Prasad
Date of Birth: 6th August 1995
Gender: Male
Marital Status: Unmarried
Nationality: Indian
Language Known: Hindi, English
Interests and Hobbies: Reading, Cricket
Permanent Address: C/O Sri Sadanand Prasad, Pugmil, Hazaribagh, Jharkhand- 825301

References:

• Dr. Aseem Mishra, Mahamana Pandit Madanmohan Malviya Cancer Centre/Homi Bhabha Cancer Hospital, Varanasi.
• Dr. Suneel Kateriya, School of Biotechnology, Jawaharlal Nehru University, New Delhi.
• Dr. Anwar Mallick, University Department of Biotechnology, Vinoba Bhave University, Hazaribagh.
• Dr. Shila Elizabeth Besra, CSIR-Indian Institute of Chemical Biology, Kolkata.
• Dr. Kumar Anand, Department of Biotechnology, Vinoba Bhave University, Hazaribagh.

Skills:

Biotechnology, Microbiology, Research Methodology, Clinical Research, Project Management, Laboratory Techniques, Data Analysis, Scientific Writing, Communication

“`

Cover Letter:

My name is Gaurav Arya, and I have completed my M.Sc. in Biotechnology from Vinoba Bhave University, Hazaribagh, Jharkhand
I have completed a project on the **anti-cancer activity of _Ocimum sanctum_ (Holy Basil)** at **CSIR-IICB (Indian Institute of Chemical Biology), Kolkata**.
Based on this work, I have published a research paper titled _”Anti-neoplastic effect of Ocimum sanctum methanol extract on colorectal carcinoma, gastric carcinoma, hepatocellular carcinoma & normal cells”_ in the _World Journal of Pharmaceutical Research_.
Professionally, I have gained valuable experience in the field:
– **Research Assistant** at VV Biotech Pvt. Ltd., where I contributed to a **preclinical study on breast cancer in rats** and supported activities in the animal research facility.
– **Project Assistant** at the **School of Biotechnology, Jawaharlal Nehru University (JNU), New Delhi**, focusing on **protein extraction and cell culture**.
– Currently, I am working as a **Clinical Trial Coordinator** in the **Department of Surgical Oncology**, MPMMCC & HBCH Tata memorial centre, BHU Campus, Varanasi. (December 2022 to till now)

MURALI N

SUMMARY

Enthusiastic and motivated Biotech graduate with Master’s degree in Biotechnology and well-versed in Pharma industry and Healthcare; Clinical Research, Clinical Data Management, Pharmacovigilance, Medical Writing, and Regulatory Affairs. Eager to leverage academic background and certification in Clinical Research, along with management experience, to contribute effectively to the pharmaceutical and healthcare profession. Ready to apply knowledge and skills to support the Pharma and healthcare team in improving patient outcomes.

SKILLS

• CLINICAL RESEARCH: Clinical trial phases I, II, III, IV, Clinical trial monitoring, Clinical trial protocols, Reports, ICF, eCRF, Trial master file/eTMF, INDA, NDA, ICH-GCP, HIPAA.
• CLINICAL DATA MANAGEMENT: Data management, Clinical data verification, Data integrity, Data collection, CRF tracking, Data entry, Data review, Data validation, Discrepancy management/Query resolution, EDC system, Medical coding, SAE reconciliation, Data audits, Database lock.
• PHARMACOVIGILANCE: Adverse effects reporting, Adverse events reporting, Drug safety, ICSR, MedDRA, Aggregate reports, DSUR, PSUR, Adverse events, Post-marketing surveillance.
• MEDICAL WRITING: Regulatory & Scientific writing, Manuscripts, Abstracts, Posters, Medico marketing, Regulatory affairs, eCTD, DMF & Regulatory compliance.
• MICROBIOLOGY: Microbiology Water analysis, In-process water BET, ENM of BSL-3 & BSL-2 facility, GPT, Sterility test (Direct inoculation method) for In-process & Finished product, Staining techniques.

OTHER SKILLS

• Communication skills
• Time management
• Project Management
• Problem-solving skills
• Analytical thinking
• Decision-making
• Stakeholder management
• Interpersonal skills

TECHNICAL SKILLS

• MS Excel
• MS Word
• Microsoft 365
• Google Sheets
• Google Docs
• QuickBooks

WORK/INTERNSHIP EXPERIENCE

QUALITY CONTROL MICROBIOLOGIST
Biovet Pvt, ltd | Malur, Karnataka | April 2024- Present

• 1 year and 2 months experience as a quality control microbiology trainee at Biovet Pvt.Ltd, Animal Healthcare
• Microbiology analysis of water.
• BET for In-Process water samples, GPT.
• ENM for BSL-3 & BSL-2 facility, Staining techniques.
• Sterility testing for In-Process samples & Finished product.

EDUCATION

• MASTER’S DEGREE IN BIOTECHNOLOGY | Bangalore University, Bengaluru, Karnataka 2019 – 2022 CGPA – 6.61
• BACHELOR’S DEGREE IN BIOTECHNOLOGY | Bangalore University, Kolar, Karnataka 2016 – 2019 CGPA – 7.51

Project

SYNTHESIS AND CHARACTERIZATION OF SILVER NANOPARTICLES FROM PREMNA INTEGRIFOLIA PLANT AND BIOACTIVE POTENTIAL | Bangalore University/ Bengaluru, Karnataka April 2020 – December 2021

• The Silver nanoparticles were found to be bactericidal against Escherichia coli.
• The silver nanoparticles also inhibited potently against bacterial culture Growth potently.
• The project helps the Silver nanoparticles that act against Bacteria, Microbial cultures, extracts from Plants, etc…

CERTIFICATIONS & PROFESSIONAL DEVELOPMENT

• ADVANCE PROGRAM OF CLINICAL RESEARCH AND MANAGEMENT | Clini India, Bengaluru July 2023 – December 2023
• CLINICAL RESEARCH
• CLINICAL DATA MANAGEMENT
• PHARMACOVIGILANCE
• MEDICAL WRITING | Clini India / Clinical Research Institute / Bengaluru
• CRICK – STAR SCHOLARSHIP STUDENT AT BIOTECNIKA | Bengaluru, Karnataka

Keywords: Clinical Research, Clinical Data Management, Pharmacovigilance, Medical Writing, Regulatory Affairs, Microbiology, Communication Skills, Time Management, Project Management, Problem-Solving Skills, Analytical Thinking, Decision-Making, Stakeholder Management, Interpersonal Skills, MS Excel, MS Word, Microsoft 365, Google Sheets, Google Docs, QuickBooks

“`

Cover Letter:

**Murali N**
Kolar, Karnataka

**Hiring Manager**
Panacea Medical Technologies Pvt. Ltd.
[Malur, Kola, Karnataka]
Subject: Application for the Position of Clinical Research Associate
Dear Hiring Manager,
I am writing to express my interest in the Clinical Research Associate (CRA) position at Panacea Medical Technologies Pvt. Ltd. With a Master’s degree in Biotechnology and a strong foundation in clinical trial monitoring, clinical data management, and pharmacovigilance, I am eager to contribute to your growing clinical team and support your mission of advancing medical technologies.
Currently, I am working as a Quality Control Microbiologist at Biovet Pvt Ltd in Malur, Kolar, where I have developed a keen eye for data accuracy, regulatory compliance, and quality assurance—skills that align well with CRA responsibilities. My academic and professional journey has equipped me with hands-on experience in:
– Monitoring clinical trials across Phases I-IV in compliance with ICH-GCP guidelines.
– Ensuring data integrity and patient safety throughout the clinical study lifecycle.
– Collaborating effectively with cross-functional teams and site personnel.
– Applying knowledge in medical writing and clinical data systems to support trial documentation and reporting.
My familiarity with regulatory frameworks, ethical considerations in research, and trial site coordination prepares me to contribute meaningfully from day one. I am particularly impressed by Panacea Medical Technologies’ commitment to innovation and would be honored to be part of your clinical research initiatives.
Thank you for considering my application. I welcome the opportunity to discuss how my background and skills align with your team’s goals. Please find my resume attached for your review.
Sincerely,
**Murali N**

Rohit Bodkhe – Curriculum Vitae

Contact Address

Permanent Address:

Plot no 24, Osmanpura, Aurangabad, Maharashtra-431001.

Career Objective

Self-motivated, highly passionate and hardworking Fresher looking for an opportunity to work in a challenging organization to utilize skills and knowledge. Detail-oriented and motivated M.Sc. Biotechnology student with strong academic background and hands-on training in Clinical Data Management (CDM). Seeking to contribute to a dynamic CDM team to ensure data quality and regulatory compliance.

Area of Interest

• Pharmacovigilance, Clinical Data Management and Clinical Research.
• Regulatory affairs related to clinical trials and pharmacovigilance (ICH-GCP, FDA, EMA guidelines).

Education

• M.Sc Biotechnology
  
  Modern College of Arts, Science and Commerce, Pune – Savitribai Phule Pune University – 2025
• B.Sc Biotechnology
  
  Mahatma Gandhi Mission, Aurangabad – Dr. Babasaheb Ambedkar Marathwada University – 2023 – 69.77%
• Intermediate (10 + 2)
  
  Vidyadham College – Maharashtra education of secondary and higher secondary – 2019 – 54.77%
• High School (10th)
  
  Anant Bhalerao Vidya Mandir – State Board – 2017 – 74.80%

Project Work

1. Isolation, Identification and Antifungal Activity Of Air Microflora in Microbiology laboratory.
2. Structure-based drug discovery: screening natural compounds for BACE1 inhibition in Alzheimer’s disease.

Clinical Data Management Training

• Biotecnika – Online CDM Certification Program
• Trained in ICH-GCP, regulatory guidelines, and CDM lifecycle.
• Practical experience in data entry, discrepancy management, and working with EDC tools.
• Exposure to SDTM/CDASH standards and SAE reconciliation.

Internship Experience

• GREENARRAY – Genomic Research & Solutions Pvt. Ltd.
  
  – Participated in genomic analysis tasks and lab-based experimentation.
  
  – Gained exposure to biotechnology techniques and research processes.

Workshop

1. Workshop | Hands on training workshop on Molecular cloning at Agharkar Research Institute.
2. Three Dimensions of Stem Cells- Drug Discovery, Drug Screening and Drug Delivery at Modern College.
3. Molecular docking at SPPU.

Technical Skills

• EDC Systems: Medidata Rave, Oracle InForm
• Clinical Data Standards: SDTM, CDASH
• CDM Processes: Data entry, query management and resolution, SAE reconciliation
• Compliance & Regulations: ICH-GCP, 21 CFR Part 11
• Database Activities: Clinical database design, User Acceptance Testing (UAT)

Strengths

• Strong understanding of clinical research and data workflows
• Quick learner and highly adaptable
• Strong communication and interpersonal skills
• Attention to detail and organizational abilities
• Team collaboration and positive attitude
• Excited to learn new things

Declaration

I hereby declare that the information provided above is true and correct to the best of my knowledge.

Place: Pune

Date:

Rohit Bodkhe

“`

Cover Letter:

**Rohit Bodkhe**
Kulshree PG, Laxman Nagar
Baner-Balewadi Road, Pune – 411045

**Hiring Manager**
Panacea Medical Technologies Pvt. Ltd.
Malur, Kolar District
Dear Hiring Manager,
I am writing to express my strong interest in the Clinical Research Associate position at Panacea Medical Technologies Pvt. Ltd. , as advertised. With a Master’s degree in Biotechnology and focused training in clinical data systems, regulatory standards, and data quality assurance, I am enthusiastic about contributing to your team and ensuring excellence in clinical data processes.
During my CDM training with Biotecnika, I gained practical experience in Electronic Data Capture (EDC) tools such as **Medidata Rave** and **Oracle InForm**, as well as a solid understanding of **ICH-GCP** guidelines, **query management**, and **SAE reconciliation**. My hands-on exposure to **SDTM/CDASH standards** and user acceptance testing has equipped me with the necessary skills to support clinical trials from a data integrity and compliance standpoint.
Academically, I have completed a Bachelor’s degree in Biotechnology and am also completed my Master’s at Modern College, Pune. My background also includes project work in antifungal microbiology and structure-based drug discovery, further strengthening my analytical and research skills.
Beyond technical abilities, I bring a positive attitude, strong communication skills, and a collaborative spirit—qualities that I believe are vital in cross-functional clinical teams. I am a quick learner, eager to apply my knowledge to real-world CDM processes while continuing to grow professionally.
I would welcome the opportunity to discuss how my background, training, and enthusiasm align with your team’s needs. Thank you for considering my application. I look forward to the possibility of contributing to your organization’s success.
Sincerely,
**Rohit Bodkhe**

“`

Cover Letter:

Dear Hiring Manager,

I am writing to express my interest in the Clinical Research Associate position at Panacea Medical Technologies Pvt. Ltd. With a Master’s degree in Biotechnology and over two years of hands-on experience in a clinical research organization, I am eager to move my career ahead in clinical research and work with your esteemed team.

Currently, I work at IQVIA RDS India as a Lab Associate in the Vaccine Team, where I worked on Eli spot application to determine the plaque formed by viral antigen and primary dengue antibodies formed for Den 1 to Den 4 antigens by microneutralization assay method of analysis. This role has deepened my understanding of GCP guidelines, GDP and regulatory frameworks. Prior to this, I served as a QC Microbiologist at Flamingo Pharmaceuticals, where I led microbial testing of both sterile and non-sterile pharmaceutical products and mentored junior staff in laboratory best practices.

Throughout my academic and professional journey, I have been driven by a curiosity to understand how microbiology intersects with public health and medical technology. My academic projects—including a published study on phytoremediation of heavy metals and a quality assessment of pharmaceutical-grade water—reflect my hands-on approach to research and data validation.

Thank you for considering my application. I would welcome the opportunity to contribute to your clinical team and am eager to bring my experience and enthusiasm to Panacea. I look forward to the opportunity for an interview.

Warm regards,
Vaishnavi Bhike

“`

Cover Letter:

Diganta Roy
Siliguri, West Bengal – 734006

Date-27th July 2025

Hiring Manager
Panacea Medical Technologies Pvt. Ltd.
Malur, Kolar District

Dear Hiring Manager,
I am writing to express my interest in the Clinical Research Associate position at Panacea Medical Technologies Pvt. Ltd. With an academic background in Biotechnology (B.Sc. and pursuing M.Sc. Hons.) and hands-on research experience at national-level institutes, I am confident in my ability to contribute effectively to your clinical research team.
During my training and current master’s research at BRIC–National Institute of Biomedical Genomics (NIBMG), I have gained experience in data handling, documentation, and working with experimental protocols. My work on zebrafish disease modeling has familiarized me with biosample tracking, adherence to SOPs, and reporting in a structured research environment. I have also worked with molecular biology techniques such as PCR/qPCR, protein/RNA isolation, western blotting, and confocal microscopy, which demand precision and attention to data integrity.
At SHRM Biotechnologies Pvt. Ltd., I was trained in GLP, SOP documentation, quality control, and microbial testing. I also handled laboratory documentation and report filing procedures in line with regulatory standards—experiences that align well with the GCP, SOP adherence, and data management expectations for this role. My training at IISER Kolkata further enhanced my understanding of sample processing, microscopy, and analytical workflows. I have a good understanding of ICH-GCP guidelines, clinical documentation, and the ethical responsibilities associated with patient safety and trial monitoring. My interest in clinical research stems from a desire to contribute to data-driven medical advancements and ensure accuracy and compliance throughout the trial lifecycle.
I am detail-oriented, highly organized, and a fast learner, eager to grow in a professional clinical research environment. I would welcome the opportunity to join Panacea’s team and contribute to its commitment to developing impactful medical technologies.
Thank you for considering my application. I have attached my resume and would be happy to discuss my background further.

Sincerely,
Diganta Roy
M.Sc. Biotechnology

Divya Bharathi B

Professional Summary

Aspiring Clinical Research Associate with hands-on experience in EDC tools (Castor, REDCap), clinical documentation, and simulated trial execution. Familiar with ICH-GCP guidelines, trial phases, and data integrity protocols. Committed to supporting patient safety, regulatory compliance, and the successful execution of clinical trials.

Education

Bharathidasan University, Trichy, Tamil Nadu

B.Tech in Biotechnology CGPA: 8.1 / Percentage: 76.85%

Certifications & Training

Clinical Data Management Certification | Biotecnika (Mar 2025 – Present)

• Used Castor EDC to enter and monitor participant-level clinical trial data.
• Simulated CRF-based data entry including adverse events, consent, vitals, and medical history.
• Ensured data consistency, standard coding (binary/date formats), and basic audit trail review.
• Practiced query generation, form validation, and CRF logic verification.
• Participated in mock team coordination exercises for CDM task delegation.
• Gained working knowledge of REDCap, trial documentation workflows, and ICH-GCP standards.

Certifications:

• Good Clinical Practice (GCP) – NIH (2025)
• Clinical Data Standards (CDASH, SDTM) – Coursera

Clinical Data Projects (Simulation-Based)

• Castor EDC Mock Trial Simulation – 2025
• Simulated full patient entry across CRFs with demographics, history, AEs, and visit schedules.
• Practiced resolving auto-generated queries and reviewed audit trails.
• Understood clinical data flow from subject enrollment to database lock.

Academic Projects

Final Year Project – CSIR-NIIST, Trivandrum (Dec 2024 – Apr 2025)

• Maintained structured research documentation and bioactivity datasets.
• Analyzed data using NMR, FTIR, and Mass Spectrometry.
• Conducted in vitro assays: DPPH, ABTS.

Minor Project – Anna University, Trichy (May – July 2024)

• Conducted molecular docking using AutoDock and validated findings experimentally.
• Organized experimental and computational datasets for reporting.

Internship Experience

• Bharathidasan University, Dept. of Bioinformatics
• Project: Methane Production by Methylotrophic Methanogen
• Handled analytical data using GC instrumentation.
• Maintained lab documentation aligned with SOPs.

Bioinformatics Internship (2023)

• Worked with ligand screening, visualization tools (PyMol, Chimera).

Skills & Tools

Clinical Knowledge & Monitoring

• Knowledge of clinical trials, study designs, and trial phases
• Familiarity with ICH-GCP guidelines and regulatory frameworks
• Understanding of data privacy, integrity, and ethical considerations in clinical research
• Ability to monitor and manage clinical site follow-ups effectively

Clinical Data Management & Compliance:

• Castor EDC (data entry, query simulation, audit trail), REDCap (data collection, form setup)
• Clinical Documentation, CRF Management, ICH-GCP, GMP, GLP, Data Quality Checks
• Query resolution, audit review, CRF validation

Analytical Techniques:

• Chromatography (Column, TLC, GC), Spectroscopy (NMR, UV-Vis, FTIR, MS)
• Bioassays: DPPH, ABTS, FRAP

Bioinformatics & Software:

• AutoDock, PyMol, Chimera, LigPlot+, PubChem, ChemDraw
• Microsoft Excel, Word, PowerPoint

Interpersonal Skills

• Strong attention to detail and accuracy in data handling
• Effective organizational, communication, and leadership skills
• Able to work independently with initiative to resolve problems
• Proven ability to collaborate and maintain professional relationships with coworkers, managers, and clients
• Comfortable with medical terminology and clinical documentation

Declaration

I hereby declare that the above information is true and correct to the best of my knowledge and belief.

Place: Trichy Signature: B. Divya Bharathi

Skills: Clinical Trials, ICH-GCP Guidelines, Data Management, Clinical Documentation, CRF Management, Bioassays, Spectroscopy, Bioinformatics, Microsoft Office, Leadership

“`

Cover Letter:

Divya Bharathi B
Trichy, Tamil Nadu
Subject: Application for the Position of Clinical Research Associate
Dear Hiring Manager, Date: 26.05.2025
I am writing to express my interest in the Clinical Research Associate position at Panacea Medical Technologies Pvt. Ltd. With a strong academic background in Biotechnology and hands-on experience in clinical research simulations, I am excited about the opportunity to contribute to your innovative work in advancing medical technologies.
Through my clinical data management training and simulation-based projects, I have developed practical knowledge of clinical trial processes, including CRF design, data accuracy checks, and mock trial monitoring using Castor EDC and REDCap. My academic and internship experiences have reinforced my skills in documentation, regulatory compliance, and analytical problem-solving. I am well-versed in ICH-GCP guidelines and understand the ethical considerations and data privacy essential to clinical research.
I am particularly drawn to Panacea’s mission of delivering advanced therapeutic solutions, and I am confident that my commitment to precision, teamwork, and continuous learning will allow me to add value to your clinical research operations. I would welcome the opportunity to further discuss how my background aligns with your goals. Thank you for considering my application. I look forward to the opportunity to speak with you.
Warm regards,
B. Divya Bharathi

Dixita Joshi

Career Objective

Motivated and detail-oriented Biomedical Science postgraduate with a specialization in Human Genetics, seeking a Clinical Research Associate position. Equipped with theoretical knowledge of ICH-GCP, clinical trial protocols, ethical regulations, and basic data handling. Eager to contribute to high-quality clinical trial operations and ensure regulatory compliance and patient safety.

Education

• Integrated M.Sc. in Biomedical Science (Specialization: Human Genetics)
  Navrachana University, Vadodara
  Expected completion: July 2025
  CGPA: 8.02/10
• Dissertation Research
• Title: Role of DNA Adenine Methylation (m6dA) in Promoter Regions of SHOX2 and RASSF1A Genes in Oral Squamous Cell Carcinoma
• Studied epigenetic changes in cancer using known biomarker genes.
• Performed DNA extraction, qPCR, and primer design.
• Analyzed methylation differences between cancer patients and healthy individuals.
• Gained hands-on understanding of data accuracy and integrity in biomedical research.

Internships

• Gene Explore Diagnostics – 15 Days
  – Learned NGS and Sanger sequencing workflow
  – Hands-on exposure to molecular and cytogenetic diagnostic testing
• DBL Enterprise – 1 Week
  – Performed protein-based assays including ELISA and Western blotting
  – Understood GCP-relevant lab documentation

Certifications

• Differential Gene Expression Analysis – Your Complete A to Z (Coursera– In Progress)
• Bioinformatics: Learn Docking & Molecular Dynamics (Udemy – In Progress)
• Data Analysis with R Programming (Coursera – In Progress)

Skills

Clinical Research Knowledge, Data Integrity & Documentation, Bioinformatics Tools, Communication & Collaboration, Software Proficiency

Academic Involvement

• Catering Committee Member – Navrachana University
  Managed logistics and food arrangements for academic events, showcasing planning and coordination skills.

Publication

Joshi, D. Hormones as a double-edged sword: the role of hormones in cancer progression and the potential of targeted hormone therapies. Medical Oncology. (First Author)

Declaration
I hereby declare that the above information is true and correct to the best of my knowledge and belief.

Date: 27/05/2025
Place: Vadodara

“`

Cover Letter:

I am writing to express my keen interest in the Clinical Research Associate (CRA) position at Panacea Medical Technologies Pvt. Ltd. With a Master’s degree in Biomedical Science (specialized in Human Genetics) and a deep interest in clinical research, I am enthusiastic about the opportunity to contribute to your innovative clinical team.
Throughout my academic journey, I have gained a foundational understanding of clinical trial design, regulatory requirements, and Good Clinical Practice (GCP) standards. My thesis project involved molecular techniques and patient-focused (Clinical research) analysis, aligning closely with the rigor required in clinical trials. I am particularly drawn to your organization’s work in medical technologies, and I am excited by the chance to contribute to data integrity, patient safety, and high-quality trial execution.
As a motivated and detail-oriented fresher, I bring strong documentation skills, familiarity with ethical guidelines, and the ability to work well with site staff and interdisciplinary teams. I am eager to learn and grow under the guidance of experienced professionals while adding value through my commitment and discipline.
Thank you for considering my application. I would be grateful for the opportunity to further discuss how I can support your clinical trial operations. I am available at your convenience for an interview.

Sincerely,
**Dixita Joshi**

Vaishnavi Yeshirao

Clinical Research Associate | Mumbai

Professional Summary

Detail-oriented Clinical Research Professional with 1.5 years of experience supporting end-to-end clinical trial execution under ICMR. Skilled in eCRF development, on-site and remote monitoring, IRB submissions, and maintaining data integrity. Knowledgeable in ICH-GCP guidelines, regulatory frameworks, and ethical standards. Seeking to leverage experience and technical skills in a Clinical Research Associate (CRA) role to ensure protocol compliance, subject safety, and high-quality data collection.

Technical Skills

• Clinical Trial Monitoring (On-site & Remote)
• Patient Safety & Data Integrity Monitoring
• eCRFs & Data Management Systems (Castor EDC, Veeva Vault)
• ICH-GCP, 21 CFR Part 11, Regulatory Compliance
• Ethical Submissions & IRB Coordination
• Data Validation & Cleaning
• Clinical Trial Lifecycle Management

Soft Skills

• Attention to Detail
• Communication
• Team Collaboration
• Critical Thinking
• Time Management

Certifications

• Principles and Practice of Clinical Research (NIH)
• Good Clinical Practice (NIDA)
• Clinical Data Management (Biotecnika)
• Regulatory Affairs
• Mini-Course EU MDR

Professional Experience

Project Technical Support III (ICMR Ad-hoc)

LTMMC, Mumbai | Mar 2023 – Sep 2024

• Conducted remote and on-site clinical monitoring activities in compliance with study protocols and GCP standards.
• Oversaw 100+ patient enrollments and ensured >90% follow-up adherence.
• Collected, cleaned, and validated clinical data using Castor EDC and Veeva Vault.
• Contributed to ethical and regulatory submissions and liaised with institutional ethics committees and sponsors.
• Ensured timely reporting and documentation of trial activities, maintaining audit readiness.
• Supported preparation of interim analysis and clinical reports.

Key Achievements

• Independently managed trial lifecycle ensuring protocol adherence.
• Played a key role in maintaining patient safety and high data quality standards.

Education

Master of Science in Microbiology

HBSU, Mumbai | 2020 – 2022

Bachelor of Science in Microbiology

University of Mumbai | 2017 – 2020

Languages

English | Hindi | Marathi

Skills

Clinical Trial Monitoring, Data Integrity Monitoring, eCRFs, ICH-GCP, Regulatory Compliance, Ethical Submissions, Data Cleaning, Clinical Reports, Attention to Detail, Communication, Team Collaboration, Critical Thinking, Time Management

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Cover Letter:

Dear Hiring Manager,

I am writing to express my strong interest in the Clinical Research Associate (CRA) position at Panacea Medical Technologies . With 1.5 years of hands-on experience in clinical data coordination under the ICMR, I am confident in my ability to contribute effectively to your clinical trial operations and uphold the highest standards of research quality and compliance.

In my previous role, I led the full lifecycle of clinical studies, from ethical submissions and eCRF development to monitoring data integrity and regulatory compliance. I successfully managed over 100 patient enrollments, maintaining a 90%+ follow-up rate and collaborating closely with site staff and sponsors to ensure accurate and timely data collection. My familiarity with ICH-GCP guidelines, data privacy standards, and tools like Castor EDC and Veeva Vault equip me to monitor trials rigorously and support your team’s success.

I am particularly drawn to your organization’s commitment to advancing high-quality clinical research. I bring not only technical competence and attention to detail but also strong interpersonal skills that enable smooth collaboration across cross-functional teams and investigative sites.

I would welcome the opportunity to further discuss how my background aligns with your goals. Thank you for considering my application. I look forward to the possibility of contributing to your team’s impactful work.

Warm regards,
Vaishnavi Yeshirao

Intro Summary: Faisal Khan M is a dedicated individual with a Master’s degree in Biotechnology. With a strong foundation in biotechnology and practical applications, Faisal has completed his education at various esteemed institutions and gained valuable skills through research projects and internships. His commitment to continuous learning and passion for making meaningful contributions positions him as a promising professional in the field.

Education:

• M.Sc Biotechnology: Completed at Garden City University
• Bachelors in Biotechnology: Completed at Garden City University (2017 – 2019)
• Pre – University Education: Completed PUC at Advitya PU college (2016 – 2017)
• High School Diploma: Completed at JSS Public School

Work Experience:

• Research Project at Vowels Lifesciences Pvt Ltd:

Skills:

Project Management, Basic computer knowledge, Equipment handling, Machine handling, Medical Coding, Research Project.

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Cover Letter:

FLAT NO 203, VR GRAND APARTMENT, RUBY ROYAL LAYOUT, MALUR MAIN ROAD
Hoskote, Karnataka 562114

Hiring Manager
Panacea Medical Technologies Pvt. Ltd
MALUR, 563130

Dear Sir/Madam,

I am writing to express my interest in the Clinical Research Associate position at Panacea Medical Technologies Pvt. Ltd, as advertised. With a Master of Science in Biotechnology and a strong foundation in molecular biology, genetics, and laboratory research techniques, I am excited about the opportunity to contribute to your team and support your mission in advancing scientific innovation.

Throughout my academic journey, I have gained hands-on experience in a range of biotechnological tools and procedures, including PCR, DNA/RNA extraction, electrophoresis, and cell culture techniques.

In addition to my technical expertise, I bring a strong work ethic, excellent communication abilities, and the flexibility to work both independently and collaboratively. I am particularly drawn to Panacea Medical Technologies Pvt. Ltd due to its reputation for, and I am eager to contribute to your ongoing projects.

I would welcome the opportunity to discuss how my academic background and enthusiasm for biotechnology can add value to your team. I have attached my CV for your review and look forward to the possibility of an interview.

Sincerely,
Faisal Khan M