Pratap P. Namekar
Mumbai
Summary
Looking for a position in clinical research area. Where I can utilize my learning attitude, hard work, sincerity, for the good research result of the organization as well as my personal growth.
Overview
6
6
Certifications
9
9
years of professional experience
Work History
Executive Clinical Trials / Clinical Research Associate
Encube Ethicals Private Limited
Mumbai
08.2024 - Current
- Explore new prospective sites and conduct feasibility survey for studies
- Assists CPM in study start-up process.
- Prepare and maintain ongoing communication withs sites to provide information, query resolution, and review overall progress of clinical trials and adherence to respective guidelines.
- Keeps the clinical project manager updates with study status.
- Regularly checking of SUGAM portal.
- Ensure the correct handling, use and storage of IP in accordance with SOPs, guidelines.
- Participated in Investigator meeting and training session.
- Ensure that timely reporting of Follow-up of adverse events, medical management.
- Mainting of TMF and ISF and CSF.
- Ensure that site staff are well trained on study Protocol, GCP and other applicable regulatory requirement.
- Prepare monitoring agenda, Monitoring report and Follow-up letter after monitoring.
- Assist with protocol, ICF and Study Plans preparations like, Study Management Plan, Site monitoring Plan.
Clinical Research Associate – I
Macleods Pharmaceuticals Limited
Mumbai
06.2017 - 11.2021
- Maintenance of Central Site File, TM
- SAE, AE reporting to Sponsor, EC & DCGI.
- Monthly, 6 monthly reports notification to EC.
- Drug/IP accountability, inventory, reconciliation, review storage and security, Verifies the IP has been dispensed and administered to the subjects/patients according to protocol.
- Attend the investigator meetings and sponsor and CRO face to face meeting, participated in Global clinical monitoring/ projects staff meeting.
- Source documentation review/ PD identification.
- CRF, Protocol and ICF review.
- Mail/Telephonic Communication with Sponsor, CRO and other stakeholders.
- Site staff protocol, IB, ICF and any other required training.
- Clinical Trails Planning like, Monitoring Planning, managements planning, SAE handling planning, PD planning and Regular Planning of visits.
- Updating the information to site like, Newsletter, EDC, IP shipments, Lab kits order etc.
- Taking and updating the clinical trial Metrics, milestones, and timelines.
- All study related documents Maintain ready 'before Audit.
- Verifies the Process of obtaining ICF has been adequately performed and documented for each subjects and patients.
- Update Sponsor for total screening, randomized, recruitment completed patient, withdrawal patients.
- Assesses factors that affects patient’s safety like, Protocol Deviation/Protocol Violation log
- Perform all duties and responsibilities in accordance with respective CRO and Sponsor SOPs
- Train study team in GCP and ensure these sites are conducting Research according to protocol
- Review investigative sites, regulatory documentation and ensure compliance with CCP
- Evaluate and Resolve Data Queries on e-CRF Databases like - Rave-Medidata, oracle etc.
- Evaluate study query trends and interact with Study Team in improving data quality.
- Effectively negotiate and manage clinical 'study budgets for the investigational sites.
- Payment process for subjects visit Invoices.
- Conducted site monitoring visits to ensure compliance with study protocols and regulatory requirements.
- Assisted in the preparation and submission of clinical trial documents to regulatory authorities.
- Collaborated with cross-functional teams to support project timelines and deliverables.
- Managed data entry and verification processes for clinical trial databases, ensuring accuracy and consistency.
- Trained junior staff on standard operating procedures and best practices in clinical research.
- Led initiatives to streamline documentation processes, reducing turnaround time for approvals and audits.
- Identified areas for process improvement within clinical operations, contributing to enhanced efficiency.
- Maintained site monitoring schedules to facilitate effective communication with members of clinical team.
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
Clinical Trials Assistant- I
KlinEra Global Services
Mumbai
11.2021 - 08.2024
- Protocol, IB and ICF customization.
- EC submissions, approval follow-up.
- Weekly/monthly meeting arrangement and attend meeting with different vendors/sponsors.
- Maintain study update tracker/payment tracker/ visit tracker/report tracker.
- CRO and subject visit payment invoice review and approval for payment.
- Lab Kits order and send to respective sites as per requirement.
- ICF translation process.
- Lab Kits order and dispatch to respective sites.
- EC approval and other documents follow-up with the sites.
- EC submissions of dossier.
- CIOMS and Safety tracker maintenance.
- Worked on Rheumatoid Arthritis, Hepatitis, Dermatology, Phase I, II, III Randomized, Double-blind Clinical Trial
Education
M.Pharmacy - Pharmacology
School of Pharmacy
01-2016
B. Pharmacy - undefined
Government Pharmacy College
Aurangabad01-2014
D. Pharmacy - undefined
Shri Shivaji institute of Pharmacy
Parbhani01-2011
HSC - undefined
Lal Bahadur Shastri, College
Dharmabad01-2007
SSC - undefined
Secondary School, Ashram shala
Kuntur Tanda01-2004
Skills
Chat GPT
Excel
Look-up
Certification
Successfully completed internship in Wockhardt Pharmaceuticals, Aurangabad.
Interests
Dancing, Singing, Travelling
Timeline
Executive Clinical Trials / Clinical Research Associate
Encube Ethicals Private Limited
08.2024 - Current
Clinical Trials Assistant- I
KlinEra Global Services
11.2021 - 08.2024
Clinical Research Associate – I
Macleods Pharmaceuticals Limited
06.2017 - 11.2021
SSC - undefined
Secondary School, Ashram shala
HSC - undefined
Lal Bahadur Shastri, College
D. Pharmacy - undefined
Shri Shivaji institute of Pharmacy
B. Pharmacy - undefined
Government Pharmacy College
M.Pharmacy - Pharmacology
School of Pharmacy
Declaration
I hereby declare that above are true to the best of my knowledge and belief.