Divya Ganesh Kamble

PERSONAL STATEMENT:

I am a highly motivated and experienced Biotechnologist, who is ambitious, logical thinker and quick learner, with a proven track record of success in the Hospital, Healthcare and Research industry.

Working over 2 years as a Clinical Trial Coordinator managed multiple and complex projects. Experience of working with PI, physicians and medical staff to correlate hospital procedures with clinical trials and reports. Proven experience with regulations regarding research projects like IEC Submissions, Patient Recruitment, Trial Management, and Data management.

Also have 2 years as a Scientific/Technical Officer in managing laboratory work, maintaining QA/QC files and data management. Possessing leadership qualities, able to adapt and execute challenging tasks. Open-minded, self-motivated, and hardworking with commendable interpersonal skills.

I am confident that I have the skills and experience necessary to be a valuable asset to your team, and I look forward to the opportunity to discuss my qualifications with you in more detail.

EDUCATION

• Diploma Clinical Research | Catalyst Institute | 2023 | PASS
• Master’s Science Biotechnology | Institute Of Science, Mumbai University | 2019 | Total CGPA: 8.40
• Bachelor’s Science Biotechnology | Bhartiya Vidhya Bhavan’s (Andheri), Mumbai University | 2017 | 61.09
• H.S.C | Bhartiya Vidhya Bhavan’s (Andheri), Maharashtra Board | 2014 | 53.85
• S.S.C | St. Anne’s High School, Malad, Maharashtra Board | 2012 | 74.00

EXPERIENCE

• Clinical Research Coordinator at ACTREC, Kharghar, Navi Mumbai | Oct 2022 – Sept 2024
• Past Experience:
  • Scientific Officer at SRL Diagnostics, Mahim, Mumbai | Nov 2020 – May 2022
  • Technical Officer at Kokilaben Dhirubhai Ambani Hospital, Mumbai | May 2022 – Oct 2022

INTERNSHIP PROJECTS

• Preparation of fruit flavored yogurt at Bhavan’s College, Department of Biotechnology
• Production of biofertilizer (phosphate solubilizing bacteria) at Rashtriya Chemical Fertilizer Ltd.

SKILL AND EXPERTISE

• Oncology Clinical Research
• Clinical Trials
• Patient/Clinical trial participant recruitment
• Clinical trial Management & Clinical Data management
• Informed consent
• REDCap
• Electronic Data Capture
• Trial Master File
• eCRF
• MS Access
• SPSS
• RAVE
• Cancer Trials Support Unit (CTSU)
• Instrument Handling
• Microbiology and Molecular Biology techniques

ACADEMIC ACHIEVEMENTS

• Participated in an event in Operon festival of S.I.E.S College
• Presented a project on fishery individually and in a group form during the bachelor’s degree
• Presented a poster on Preparation of fruit flavored yogurt at Institute of Science, 2019
• Organized a survey on tasting of fruit flavored yogurt in Bhavan’s College
• Attended a field visit to National Institute for Research in Reproductive Health (NIRRH)

I hereby declare that the above-written particulars are true to the best of my knowledge and belief.

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Cover Letter:

Dear Hiring Team,

I am **Divya Ganesh Kamble**, writing to express my interest in the positions of **Clinical Research- CTA, CDM, CRA**. As a highly skilled and motivated individual with a passion for research and a strong background in healthcare.

My previous roles as a **Scientific Officer at SRL Diagnostics **and **Kokilaben Hospital** and currently working as **Clinical Research Coordinator (TATA MEMORIAL HOSPITAL- PAREL & ACTREC- Kharghar) ** have experience in preparing study documents such as informed consent forms, study protocols, submissions, patient counselling, eCRF, TMF and maintaining GCP.

I hold a Bachelor’s degree and a **Master’s degree in Biotechnology** with a **Diploma (PGDCRC) in Clinical Research** from a reputable institute.
Thank you for your attention to this matter and I eagerly await your response.
 

Regards,
Divya Kamble

**AMPABATHINA NANDINI**
D. No: 26/2/136, Kanneluru Village,
Jammalamadugu Mandal, Kadapa
district, 516434.

**CAREER OBJECTIVE:**
To work for an organization which encourages me to succeed and grow professionally where I
can utilize my skills and knowledge to grow along with the organization objective.

**ACADEMIC QUALIFICATIONS:**
– MSc
– Specialization: Bioinformatics
– Institution: SVIMS University, Tirupati
– University: SVIMS University, Tirupati
– Percentage: 81.2%
– Year of passing: 2024

– BSc
– Specialization: Biotechnology
– Institution: SKSC Degree College, Proddatur
– University: YVU University, Kadapa
– Percentage: 93.69%
– Year of passing: 2022

– Intermediate
– Specialization: BiPC
– Institution: Vivekananda Jr. College, Jammalamadugu
– Board: BIE
– Grade: 9.2 (CGPA)
– Year of passing: 2019

– SSC
– Institution: St. Mary’s English Medium High School
– Board: BSE
– Grade: 9.3 (GPA)
– Year of passing: 2017

**TECHNICAL SKILLS:**
– C & C++
– PERL
– RDBMS & SQL
– Bioinformatics tools and databases
– Biotechnology practical handling

**PROJECT:**
– Title: Designed Alanine aminotransferase1 (ALAT1) agonist for Parkinson’s disease
– Description: In Parkinson’s disease reduced ALAT1 expression impairs glutamate regulation, disrupting the glutamate-glutamine cycle and leads to neurodegeneration which results in Parkinson’s disease. Enhancing ALAT1 activity restores glutamate levels, boosts metabolic balance, reduces neurodegeneration, and protects dopaminergic neurons. Hence ALAT1 activators have been designed to enhance its expression using bioinformatics tools and databases.

**WORK EXPERIENCE:**
– DBT- Studentship: Bioinformatics (6 months)
– Title: Immuno-informatics driven peptide based vaccine design against FZD2 in breast cancer
– Description: Immuno-informatics enables the design of peptide vaccines targeting FZD2 in breast cancer by identifying potent epitopes. These vaccines can activate immune responses, aiding in tumor suppression. Computational methods ensure high affinity, stability, and broad population coverage. This approach holds potential for effective and personalized cancer immunotherapy.

**STRENGTHS:**
– Ability to adjust with new environment
– Ability to work smart
– Ability to hard work and respecting the job
– Effective communication and time management
– Good analytical and decision making

**PERSONAL DETAILS:**
– Father’s name: A. Veeraiah
– Mother’s name: A. Reddy Roja
– Date of birth: 22/06/2002
– Gender: Female
– Marital Status: Single
– Nationality: Indian
– Languages Known: Telugu, English, Hindi
– Hobbies: Explorer & Family leisure

**REFERENCES:**
1. Dr. A. Umamaheswari
Professor and HOD,
Department of Bioinformatics, SVIMS, Tirupati

2. Dr. P.V.G.K. Sarma
Professor and HOD,
Department of Biotechnology, SVIMS, Tirupati

**DECLARATION:**
I, A. NANDINI, do hereby confirm that the information given above is true to the best of my knowledge.

Date:
Place:

Yours faithfully,
(A.NANDINI)

**SKILLS:**
C & C++, PERL, RDBMS & SQL, Bioinformatics tools and databases, Biotechnology practical handling
“`

Cover Letter:

A. Nandini
Kadapa, Andhra Pradesh
Date: 28/05/2025

**Subject:** Application for the Clinical Research Associate Position

Dear Hiring Manager,
I’m reaching out to express my enthusiasm for the Clinical Research Associate (CRA) position at Panacea Medical Technologies Pvt. Ltd., as advertised. I recently completed my Master of Science in Bioinformatics from SVIMS University, Tirupati, where I built a solid foundation in clinical research principles, data analysis, and regulatory compliance.

During my postgraduate studies, I worked on a project titled “Design of Agonist for Parkinson’s Disease,” which really deepened my understanding of drug development and the various phases of clinical trials. Additionally, I completed a six-month DBT Studentship focused on “Immuno-Informatics Driven Peptide-Based Vaccine Design for Breast Cancer.” This experience sharpened my skills in data management, understanding regulatory guidelines, and scientific documentation—all crucial for a successful CRA.

I’m highly motivated, detail-oriented, and eager to contribute to clinical research while ensuring compliance with GCP and regulatory standards. I have strong communication and interpersonal skills, and I’m confident in my ability to work effectively with site staff and cross-functional teams.

I’m excited about the chance to join your team and help advance medical technologies. Thank you for considering my application. I look forward to the opportunity to discuss how I can be a valuable part of your clinical research team.
Sincerely,
A. Nandini

Mayuri Dadmal
Plot.no 182, Suraj Nagar, Hingna, Nagpur, Maharashtra 441110

Objective
Life science postgraduate with Knowledge of Clinical Research Domains and passion for clinical research, excited to apply my knowledge and research skills to innovative healthcare solutions. Committed to learning and dedicated to making a meaningful impact in Clinical Research.

Experience
All India Institute of Medical Sciences, Nagpur
Trainee Clinical Research Coordinator (Internship)
Under the supervision of Canvass clinical research services Pvt Ltd.
During this period the clinical trial related activities observed are:
Consenting process, Subject Recruitment/ Randomization, IP Handling, Safety Reporting, IEC Communication, Handling eCRF/ IWRS, ISF etc

Education
Canvass Clinical Research Services Pvt Ltd
Advance Diploma in Clinical Research
70%
University of Hyderabad
M.Sc Biochemistry
SGPA: 8.21
Dr Ambedkar College, Rashtrasant Tukadoji Maharaj Nagpur University
B.Sc Biotechnology
70.70%
Vidarbha Buniyadi Jr College, Nagpur
HSC
74.62%
School of Scholars
SSC
CGPA: 8.6

Skills
Basic knowledge of Clinical Trial Management, Clinical Data Management, Pharmacovigilance, Regulatory affair, and eTMF and the interlink between them.
Basic knowledge of protocol understanding, essential documents, NDCT 2019, ICH-GCP.
Awareness of ISF, Source document writing.
Basic knowledge of safety reporting.
Awareness of Investigation Product Handling and EDC.
Awareness of subject visit Handling and subject Recruitment
Knowledge of Clinical Trial software Handling: Oracle (EDC), Octalsoft, Excelsior LIMS, Smooth
Can work on MS Word, MS Excel, MS PowerPoint, and have good knowledge of Handling laptop and desktop.

Strengths
Willingness to learn, Ability to work in a team, Time Management, Quick learner, Leadership quality

Languages
English, Hindi, Marathi

Certifications
Hands-on training program entitled “ANIMAL TISSUE CULTURE” organized by Department of Biotechnology and Biochemistry. Dr Ambedkar College, Nagpur
Hands-on workshop on Chemoinformatics approaches in Drug Discovery conducted by EdGene BioMed Pvt Ltd. India
Participated in Hy-Sci Conference (Hyderabad’s Student-centric Conference) held at the Centre for DNA Fingerprinting and Diagnostics, Hyderabad, India

Extracurricular Activities
Worked as mentor/volunteer of the Campus Chapter “Seeding Labs” Dr Ambedkar College, Biochem-Biotech Society India (A Seeding Labs, Boston USA Approached Campus Chapter)

Personal Details
Father’s Name: Balwant Dadmal
Mother’s Name: Jayashree Dadmal
Nationality: Indian
Gender: Female
Religion: Hindu

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

Skills: Clinical Trial Management, Clinical Data Management, Pharmacovigilance, Regulatory Affairs, eTMF, Protocol Understanding, Safety Reporting, Investigation Product Handling, Subject Recruitment, MS Office Suite, Leadership.

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Cover Letter:

**To:** Hiring Manager
Panacea Medical Technologies Pvt. Ltd.
**Subject:** Application for Clinical Research Associate
Dear Hiring Manager,
I am writing to express my interest in an Clinical Research Associate position at your organization. As a postgraduate in Biochemistry from the University of Hyderabad with a recent diploma and internship in Clinical Research, I am eager to begin my professional journey in this field.
During my internship at AIIMS Nagpur (in collaboration with Canvass Clinical Research Services), I gained hands-on exposure to trial coordination, subject recruitment, informed consent processes, and safety reporting. I developed familiarity with tools such as eCRF, IWRS, and various EDC platforms.
I bring with me a strong academic foundation, a deep interest in research ethics, and a willingness to continuously learn and adapt. Though I had to take time to recover from a health setback last year, I am now fully focused and committed to building a meaningful career in clinical research.
I would be grateful for the opportunity to contribute to your team and further develop my professional skills. Thank you for considering my application.
Warm regards,
**Mayuri Dadmal**

Resume

Intro Summary: Anil Surya Yellapantula is an aspiring Clinical Research Associate with a background in M.Pharm in Regulatory Affairs. He aims to contribute to clinical trial operations, site coordination, and regulatory documentation.

Objective

Aspiring Clinical Research Associate, graduate in M.Pharm in Regulatory Affairs, aiming to contribute to clinical trial operations, site coordination, and regulatory documentation. Skilled in ICH-GCP, ethics committee processes, and EDC systems, with a strong foundation in compliance and patient-centric research.

Experience (Academic Project Role)

• Drafted sample informed consent forms and protocol summaries
• Simulated EC submission packets
• Assisted in analyzing real-world regulatory case studies

Education

• Chandigarh College of Pharmacy, Mohali, India
  M.Pharm in Regulatory Affairs, 2023–2025 CGPA: 8.8
• Maharajah’s College of Pharmacy, Vizianagaram, India
  Bachelor of Pharmacy, 2019–2023 CGPA: 7.6

Key Competencies

• Clinical trial startup assistance
• Regulatory binder preparation
• Study protocol familiarity
• Patient communication understanding
• EC/IRB documentation knowledge

Clinical Research & Regulatory Skills

• ICH-GCP, Schedule Y, FDA, CDSCO, and EMA guidelines
• Ethics Committee & IRB submissions
• Informed Consent Form (ICF) design and review
• CRF handling and data entry (EDC platforms: REDCap, Medidata)

Software Proficiency

CTMS, Veeva Vault (Basic), MS Office, Google Workspace

Soft Skills

Attention to detail, strong time management, clear communication, adaptability, collaborative team player, documentation accuracy

Academic Projects

• Regulatory hurdles and patient-centric perspectives on cochlear implants: A survey-based study evaluating clinical and regulatory barriers – including ethics submissions, informed consent, and post-market feedback.
• Bland Altman Plot comparative study of new validated IR-ATR & UV-Spectroscopic Methods for estimation of Rosuvastatin Tablets.
• A review on NCAR system.

Certification Courses

• Pharmaceutical and Medical Device Innovation – Coursera
• Clinical Trials Management and Advanced Operations – Coursera

Conferences & Presentations

• Participated in 72nd Indian Pharmaceutical Congress, Nagpur
• Poster presentation in Pharma Anveshan 2024 on National Pharmacy Education Day
• Participated in International Conference at Uttaranchal University

Declaration

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

Yours sincerely,
Anil Surya

Skills: Clinical trial startup assistance, Regulatory binder preparation, Study protocol familiarity, Patient communication understanding, EC/IRB documentation knowledge, ICH-GCP, Ethics Committee & IRB submissions, Informed Consent Form (ICF) design and review, CRF handling and data entry (EDC platforms: REDCap, Medidata), CTMS, Veeva Vault (Basic), MS Office, Google Workspace, Attention to detail, strong time management, clear communication, adaptability, collaborative team player, documentation accuracy.

“`

Cover Letter:

**Anil Surya Yellapantula**
Mohali, Punjab
28/05/2025
**Subject:** Application for Clinical Research Associate Position
Dear Hiring Manager,
I am writing to express my interest in the Clinical Research Associate position at Panacea Medical Technologies. As a recent M.Pharm graduate in Regulatory Affairs from Chandigarh College of Pharmacy, I bring strong knowledge of ICH-GCP guidelines, clinical trial protocols, and regulatory documentation. My academic project on cochlear implants involved informed consent design and ethics committee submissions, providing hands-on experience with regulatory and patient-centric research practices.
With working knowledge of CTMS, Veeva Vault, and EDC systems such as REDCap and Medidata, combined with solid communication and organizational skills, I am confident in my ability to support clinical trial operations effectively. I am eager to contribute to Panacea’s mission in advancing healthcare innovation and would welcome the opportunity to discuss how I can add value to your research team.
Warm regards,
**Anil Surya Yellapantula**

Profile

Motivated biotechnology graduate with a keen interest in biomedical diagnostics and healthcare innovation. Strong foundation in molecular biology, genetics, and clinical research methodologies. Skilled in diagnostic assay techniques, data analysis, and scientific communication. Enthusiastic about leveraging cutting-edge technologies like Electrogastrography (EGG), ELISA, and LAMP PCR to address unmet diagnostic needs. Committed to contributing towards improving patient care and advancing diagnostic solutions while fostering meaningful collaborations with healthcare professionals.

Education

• Matriculation (CBSE) |KENDRIYA VIDYALAYA
• Session: 2019- 20| Percentage: 61%

Certificates and Achievements

• Training in MRD life science (June 2024)
  • Purpose of the Training: Learn about PCR, Spectrophotometer and Handling Lab Equipments
• Chegg Freelance Assignment and Payment Certificate
• LINKEDIN LEARNING
  • Time Management
  • Entrepreneurship

Language

• English
• Hindi

Expertise

• Decision making
• Adaptability
• Effective Communication
• Multitasking
• PCR
• ELISA
• Biomedical Diagnostics
• Analytical techniques

“`

Cover Letter:

Dear Hiring Manager,

I am writing to express my interest in the biotechnology position at your organization. As a recent graduate with a Bachelor’s degree in Biotechnology from Chandigarh University, I am eager to contribute my academic background and hands-on training to a team focused on innovation in biomedical diagnostics and healthcare research.

My experience includes training at MRD Lifesciences, where I developed practical skills in PCR, spectrophotometry, and laboratory equipment handling. In addition, my work as a Chegg freelance biochemistry tutor helped strengthen my scientific communication skills and analytical thinking. I have a strong foundation in molecular biology, genetics, and diagnostic assay techniques, and I am particularly interested in using tools like ELISA and PCR to address diagnostic challenges.

I am a quick learner with excellent adaptability, time management, and multitasking abilities. My passion lies in leveraging biotechnology to improve patient care and develop practical, real-world solutions. I am enthusiastic about the opportunity to contribute to your organization’s mission and grow professionally within your team.

Thank you for considering my application. I look forward to the possibility of discussing how my background and goals align with your needs.

Sincerely,
Shishir Pandey

Vandhana V

Naganathapura, Hosa road,
Electronic city,
Bangalore 560100

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CAREER OBJECTIVE:

To work in an innovative & demanding environment where I shall prove to be a valuable team member contributing quality ideas & work for an organization where I can constantly learn skills and knowledge, to build a long term career with opportunities for career growth.

---

WORKING EXPERIENCE:

Quality Analyst (Part-Time)
Shree Krishna Beverages – Water Purification Division
Bangalore, [sept, 2021] – [june, 2024]

• Conducted quality control tests on purified water samples to ensure compliance with FASSI.
• Monitored and maintained documentation for daily water testing parameters (pH, TDS, hardness, microbial contamination).
• Assisted in calibration and maintenance of lab equipment and ensured hygiene and safety standards were followed.
• Supported the team during internal audits and contributed to improving SOPs for water purification and packaging.

---

KEY STRENGTHS:

• Learning & development oriented
• Strong collaborative approach
• Highly organized
• Rapid learning capability
• Innovative problem-solving
• Strong decision-making

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ACADEMIC PROFILE:

• M.Sc [Microbiology] from Maharani Cluster University – 8.8/10 (CGPA) 2024 passed out.
• B.Sc [Chemistry, Zoology and Bio-Technology] from Maharani Cluster University –8.5/10 (CGPA).

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CERTIFICATES:

• Good clinical practices- ICH guidelines E6 R2 (E-Certificate from Alison institute)
• HACCP Food safety system for Restaurants and other Catering Services (E-Certificate from Alison institute)
• Food Safety: Good Manufacturing Practices (GMP) in the Food Industry (E-Certificate from Alison institute)

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SKILL SET:

Serological tests, Biochemical tests, Spectrophotometer, LAF, Autoclave, Aseptic Inoculation, DNA extraction, Centrifuge, Chromatographic techniques, Media preparation, ELISA, Electrophoresis, Bioinformatics (PUBMED, NCBI, FASTA, BLAST, EBI, ORI FINDER, SEQUENCE ALIGNMENT, MULTIPLE SEQUENCE), have knowledge of HPLC.

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TECHNICAL SKILLS:

MS Office (Word, Excel), Speed typing, Tally, PowerPoint.

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EXTRA CURRICULAR ACTIVITIES:

• Participated in Educational Trip Organized by Biotechnology Department to “GROUP PHARMA” and “MEDO PHARMA, Malur”.
• Participated In 45-Day Intensive Training Program on Core Employability Skills at MSDF [2022-2023].
• An Industrial visit to “SULA WINE WARDS”.
• A Field trip to “CENTRAL INSTITUTE OF MEDICINAL AND AROMATIC PLANTS”.

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PROJECT:

Exploring “NOVEL MICROBIAL SOURCE ENHANCED” L-asparaginase production.

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PERSONAL PROFILE:

• Name: Vandhana V
• Father Name: Venkatesh M V
• Date of Birth: 14th February 2000
• Nationality: Indian
• Sex: Female
• Marital Status: Single
• Hobbies: Travelling, Reading books, Listening to music, and Cooking.
• Languages: English, Kannada (read and write), Telugu, Tamil (speak only)

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DECLARATION:

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

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Skills: Serological tests, Biochemical tests, Spectrophotometer, LAF, Autoclave, Aseptic Inoculation, DNA extraction, Centrifuge, Chromatographic techniques, Media preparation, ELISA, Electrophoresis, Bioinformatics, HPLC, MS Office (Word, Excel), Speed typing, Tally, PowerPoint

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Cover Letter:

Vandhana V
Hosa road, electronic City
Bangalore, India

Hiring Manager
Panacea medical terminologies

Dear Hiring Manager,

I am writing to express my interest in a position within your Clinical Research Associate. I am a recent MSc Microbiology graduate from Maharani Cluster University with two years of part-time experience in Quality Assurance. My academic background, combined with my practical experience in QA, has equipped me with a strong foundation in research methodology, documentation practices, and regulatory standards, all of which are crucial in clinical research.

During my postgraduate studies, I gained extensive knowledge in microbiological techniques and data analysis. My coursework emphasized research ethics, experimental design, and laboratory management. Concurrently, my part-time QA role enabled me to develop a keen eye for detail and a disciplined approach to documentation and compliance—skills directly transferable to clinical research operations.

I am particularly drawn to the clinical research field because of its vital role in advancing healthcare. I am eager to contribute to high-quality, ethically sound research that makes a real impact on patient outcomes. I am confident that my blend of academic knowledge and hands-on QA experience will make me a valuable addition to your team.

Thank you for considering my application. I welcome the opportunity to discuss how my background aligns with your department’s goals. Please find my resume attached for further details.

Sincerely,
Vandhana V

Introduction:

Name: Parvathy Venugopal
Address: B-4, Kute Vrindavan, Behind Vitthal Mandir, Akurdi, Pune – 41103
Contact: [Removed]
Email: [Removed]

Objective:

Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals. Hardworking and passionate job seeker with strong organizational skills. Ready to help team achieve company goals.

Skills:

• Clinical Research
• ICH-GCP Guidelines
• TMF
• Clinical Data Management
• Collaborative Teamwork
• Excellent communication
• Multitasking abilities
• Organizational skills

Education:

Jan 2025 – Present
Advance PG Diploma in Clinical Research, Mitcon Institute

July 2019 – April 2022
BSc. Biotechnology, University of Calicut

Experience:

Jan 2022 – Amplicon Biolabs – Basic techniques in microbiology and molecular biology.

March 2024 – Monera Labs – Basic chemical analysis of water.

May 2024 – Dec 2024 – Asha Kiran Hospital Pathology lab – Analysis of body fluids.

Languages:

English, Hindi, Malayalam

Declaration:

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

Keywords:

Clinical Research, ICH-GCP Guidelines, TMF, Clinical Data Management, Collaborative Teamwork, Excellent communication, Multitasking abilities, Organizational skills

“`

Cover Letter:

I have a post graduate diploma in clinical research and looking for opportunities. I am good with communication and a good team player

Dr. Shashank M Jogur

Address: Vijayanagar, Bangalore Karnataka – 560040

Professional Summary

Detail-oriented and highly motivated Pharm.D graduate with hands-on exposure to
pharmacovigilance and safety data management, complemented by a strong understanding of
document management best practices. Skilled in collecting, tracking, and processing adverse events
(AEs), writing narratives, and MedDRA coding. Knowledgeable in ICH-GCP guidelines and safety
regulations including FDA and EMA. Seeking to leverage strong organizational, analytical, and
communication skills to contribute to a safety operations team, specifically in a dynamic document
management role focused on maintaining compliance and data accuracy within eTMF systems.

Core Competencies

• Document Management and Archiving (Paper and Electronic)
• Electronic Trial Master File (eTMF) Maintenance and Quality Control
• Regulatory Compliance (ICH-GCP, FDA, EMA)
• Adverse Event (AE) Data Collection and Tracking
• Case Processing and Database Entry
• Safety Narrative Writing and MedDRA Coding
• Data Entry and Quality Checks
• Strong Attention to Detail and Time Management
• Effective Verbal and Written Communication
• Proficient in Microsoft Office (Word, Excel, PowerPoint) and Web-Based Tools
• Literature Search Tools (Pubmed training exposure)
• Scientific writing

Education

Doctor of Pharmacy (Pharm.D) | BLDEAS SSM College of Pharmacy, Vijayapura

• Completed coursework in pharmacology, toxicology, and clinical research

Certifications & Training

• Good Clinical Practice (GCP) Certification
• Certified in Medical Terminology (CMT)
• Basic Life Support (BLS) – Cardiology Focus
• Certificate in Clinical Research – Clindus Academy Solutions

Research and Internship Experience

• Pharm.D Internship | BLDEAs Hospital, Vijayapura
• Assisted in clinical trial-related tasks including AE tracking and reporting
• Supported safety documentation and IRB submission preparation
• Contributed to data entry and quality checks to ensure regulatory compliance
• Interpreted lab reports and helped review patient medication charts for ADRs
• Gained practical exposure to maintaining accurate and complete clinical trial records

Technical Proficiency

• Document Management: Electronic Trial Master File (eTMF) applications (training exposure), Paper Document Collection, Indexing, Storage, Retrieval, Archiving Databases
• Software: Microsoft Word, Excel, PowerPoint
• Coding: MedDRA Coding (training exposure)
• Databases/Tools: Pubmed (training exposure)

Publications

• Cyclosporine-Induced Hypertrichosis and Hypokalemia in an Infant: A Case Report Journal of Hospital Pharmacy (JOHP), 2025-1

Project

• Assessment of Medication Adherence in Cardiovascular Disease Patients Conducted at BLDEA’s Hospital under the guidance of Dr. Sunanda Nandikol

Skills

Document Management, eTMF, Regulatory Compliance, Adverse Event Tracking, Data Entry, Safety Narrative Writing, MedDRA Coding, Time Management, Communication, Microsoft Office, Literature Search, Scientific Writing

“`

Cover Letter:

Dear HR/ Recruiter
I am Shashank Jogur, Pharm D graduate writing this to show interest in Clinical research associate job as posted recently
My skills and experience allign to the job description and my clinical trial knowledge would be fit for this job role
Kindly consider me for this role and please review my CV
Thank you
Shashank M Jogur
interested

Gayatri Raghunath Kulkarni

Location: Kolhapur, Maharashtra

Profile

I am a dedicated MSc Biotechnology student with a profound understanding of molecular biology and genetics. My expertise includes PCR, protein purification, and bioinformatics analysis, complemented by strong analytical skills in HPLC and UV-Vis spectrophotometry. I am committed to contributing to innovative research projects while upholding stringent laboratory protocols.

Education

• Master of Science in Biotechnology (M.Sc): Shivaji University of Kolhapur, 2023-2025, CGPA: 8.18
• Bachelor of Science in Biotechnology (B.Sc): Vivekanand College of Kolhapur, 2020-2023, CGPA: 8.79

Skills

• Core Laboratory Skills: Protein and Molecular analysis, Microscopy Techniques, DNA/RNA Extraction, Polymerase Chain Reaction (PCR), Gel Electrophoresis, Aseptic Techniques
• Protein and Molecular Analysis: Western Blotting, ELISA, UV-Vis Spectroscopy & Microplate Reader, HPLC, Gel Doc
• Computational Tools: Clustal W & BLAST, CHIMERA & RasMol, Molecular Docking, Sequences Alignment Tools, MS Office

Work Experience

Internship: Clinical Research Trainee

Aster Aadhar Hospital, Kolhapur

May 2024

• Improved data accuracy through meticulous review of Case Report Forms (CRF) and Electronic Case Report Forms (eCRF).
• Contributed to the successful execution of clinical trials, assisting in data analysis for actionable medical insights.
• Ensured adherence to Good Clinical Practice (GCP) standards.
• Streamlined data collection methods, cutting reporting errors through systematic documentation.
• Collaborated with a team of research professionals for project success.

Research Experience

Project 1: Extraction and Isolation of Beta-Glucan from Oats, Wheat, and Barley Using Alkaline Extraction

• Optimized extraction methodology for maximizing beta-glucan yield and purity.
• Performed dialysis for purification and spectrophotometric analysis for quantification.
• Validated extraction efficiency through comparative analysis.

Project 2: Evaluation of Pharmacological and Medicinal Properties of Momordica dioica and Chenopodium album

• Identified and characterized bioactive compounds through experimental studies.
• Conducted phytochemical screening and spectrophotometric assays for analysis.
• Applied statistical analysis for data interpretation.

Certificates

• “Preparation of Household chemicals and perfumes”
• On-Demand Human Hepatic Organoid Course
• Human intestinal on-demand training course
• “University-level Model presentation competition at CRSPIR 2025”
• Bioinformatics techniques for Nanobiotechnology and Clinical research
• Certificate of Participation for successful completion of 1-day visit in field of Research Activities at Biocyte Institute Of Research and Development, Sangli
• University-level Aavishkar research poster presentation competition participation

“`

Cover Letter:

Gayatri Raghunath Kulkarni
Kolhapur, Maharashtra
28/05/2025
**Hiring Manager**
Panacea Medical Technologies Pvt. Ltd.
**Subject:** Application for Clinical Research Associate Position
Dear Hiring Manager,
I am excited to apply for the Clinical Research Associate position at Panacea Medical Technologies Pvt. Ltd. With a strong background in your relevant expertise, in clinical research, I am eager to contribute my skills to your esteemed organization.
In my previous role as Clinical research trainee at Aster Adhar Hospital Clinical Research Department, I gained experience in key skills such as clinical trial monitoring, regulatory compliance, data analysis, or patient coordination. My ability to collaborate with multidisciplinary teams and adhere to rigorous research protocols aligns well with the standards of Panacea Medical Technologies.
I am particularly drawn to this opportunity because of a reason, such as the company’s innovative research, reputation in medical technology, and contributions to healthcare advancements. I am confident that my expertise, attention to detail, and dedication to ethical research will make me a valuable addition to your team.
I have attached my resume for your review. I would appreciate the opportunity to discuss how my skills align with your research objectives. Please feel free to contact me at your convenience.
Thank you for your time and consideration. I look forward to your response.
**Best regards,**
Gayatri Raghunath Kulkarni

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