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Damini Gujar
Clinical Research Associate
Panvel
Summary
Clinical Research Associate with 2.5 years of experience in managing clinical trials. Skilled in monitoring sites, ensuring regulatory compliance, and collecting data. Familiar with ICH-GCP guidelines and EDC systems, committed to supporting smooth and successful research projects
Overview
3
3
years of professional experience
5
5
years of post-secondary education
3
3
Languages
Work History
Clinical Research Associate
DiagnoSearch LifeSciences Private
Mumbai
07.2023 - Current
- Coordinate the implementation of clinical protocol and documentation at the assigned sites in accordance with GCP, company / sponsor SOPs (as applicable) and applicable regulatory requirements
- Coordinate, schedule and conduct site initiation, routine monitoring and closeout visits as per protocol and monitoring plan.
- Verify whether the most updated IRB/ IEC approved informed consent forms are used by the site during the consent process and the informed consent process is appropriately documented for each study subject.
- Review source documents and verify against eCRF for completeness, accuracy and compliance. Assist site in resolving queries raised by Data Manager or Medical Monitor.
- Ensure that non-serious and serious adverse events are documented and reported in compliance with safety reporting procedures / timelines.
- Reconcile regulatory documents filed in the ISF with in-house study files/ eTMF during the monitoring visits to ensure availability and accuracy
- Ensure that at all times, drug, non-drug clinical supplies, facilities and personnel are adequate at the assigned study sites.
- Coached, guided and supported investigators and site staff to maintain progress towards study objectives.
- At the end of the visit, prepare and finalize site visit report as per the defined timelines.
- Translation and back translation of core study documents (e.g., Informed Consent Document, Diaries), ancillary data: Submission, follow up, in-house verification and documentation.
- Co-ordinate start-up activities, prepare IRB/IEC dossiers in coordination with PM / site CRA based on IRB/ IEC document requirements and ensure timely IRB/ IEC submissions (initial and subsequent approval, annual status reports, etc)
- On an ongoing basis, upload of documents on eTMF/ file documents in In-house study files and maintain electronic filing on the server with appropriate nomenclature.
- Update project tracking tools and status reports.
Trainee Clinical Research Associate
AnaZeal Analytical and Research Pvt. Ltd.
Mumbai
06.2022 - 06.2023
- Assist in the preparation and finalization of Confidentiality Agreements and Clinical Trial Agreements.
- Prepared Investigator Site File (ISF) as well as in house study file, compile and review the regulatory documents of the sites as per the filing structure approved for the study.
- Drafted agenda, minutes and other meeting material for sponsor/Internal meetings
- Conducted co-monitoring visits to ensure accuracy, consistency and protocol compliance through on-site review file, records, source data verification against case report form.
- Ensured timely completion of all deliverables by tracking project timelines and milestone.
- Ensured Trail Master File and study logs are constantly updated.
- Maintained accurate records of study progress and ensured availability of study materials.
Education
Certification Course - Advance Program in Clinical Research & Management.
Clini India
Mumbai 05.2021 - 10.2021
Master of Science - Genetic Engineering
School of Biotechnology And Bioinformatics,DYPatil
Navi Mumbai 07.2018 - 04.2020
Bachelor of Science - Life Sciences
Ramnairan Ruia College
Mumbai 07.2015 - 04.2018
Skills
Clinical documentation
Clinical data management
IRB submissions
Project management
Site management
Electronic data capture
ICH guidelines
Good clinical practice
Adaptability and flexibility
Good Communication
Software
Wide Angle Insights (EDC and eTMF)
Hobbies
- Traveling
- Reading
- Listening to Music
Therapeutic Area
- Gastroenteritis
- Vaccine
- Musculoskeletal Pain
- Unani
Timeline
Clinical Research Associate
DiagnoSearch LifeSciences Private
07.2023 - Current
Trainee Clinical Research Associate
AnaZeal Analytical and Research Pvt. Ltd.
06.2022 - 06.2023
Certification Course - Advance Program in Clinical Research & Management.
Clini India
05.2021 - 10.2021
Master of Science - Genetic Engineering
School of Biotechnology And Bioinformatics,DYPatil
07.2018 - 04.2020
Bachelor of Science - Life Sciences
Ramnairan Ruia College
07.2015 - 04.2018
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