BHAVESH BAROT
CLINICAL RESEARCH ASSOCIATE
AHMEDABAD
Summary
Accomplished Clinical Research Associate with 2 years and 6 Months of experience performing and documenting pre-study site evaluations, regulatory document collection, interim monitoring and study close-out visits. Diligent in performing studies aligned with good clinical practices, study-specific requirements and clinical monitoring plans. In-depth knowledge of company procedures, regulatory requirements and quality standards.
Overview
6
6
years of professional experience
6
6
years of post-secondary education
2
2
Languages
Work History
CLINICAL RESEARCH ASSOCIATE
LET’S EVOLVE LIFE PVT. LTD
AHMEDABAD
08.2021 - 10.2022
- Performs initial qualification visits of potential investigators
- Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
- Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
- Coordinate activities with site in preparation for initiation of studies
- Participates in investigator recruitment process
- Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials
- Obtaining regulatory (IRB/IEC) approval for study-specific documents
- Performing Site initiation visits and verifying that investigator and investigator’s team are adequately trained and comply with protocol
- Preparing initiation visit reports and follow-up letters
- Assists with, and attends, Investigator Meetings for assigned studies
- Periodic SMF/ISF filling and auditing to ensure compliance with GCP and SOP
- Assuring adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits
- Performing validation of source documentation as required by sponsor
- Preparing site monitoring reports and follow-up letters within stipulated time as per SOP and sponsor requirements
- Also taking follow-up for open action items
- Reviews quality and integrity of clinical data through (1) In-house review of electronic CRF data and (2) on-site source verification
- Work with sites to resolve data queries
- Reviews protocols, eCRFs, study manuals, and other related documents, as requested by Project Manager
- Serves as primary contact between company and investigator; coordinates all correspondence; ensures timely transmission of clinical data with study site and technical reporting, as requested
- Escalating observed deficiencies and issues to clinical management expeditiously, proposing solutions, and following all issues through to resolution
- Maintain regular contact with investigative sites to confirm that protocol is being followed, that previously identified issues are being resolved, and that data is being recorded in timely manner
- Assisting in final data review and query resolution through database lock
- Performing study close-out visits
- Ordering, tracking, and managing IP and trial materials accountability, Investigational Product stability, and storage conditions of investigational product on site as required by sponsor
- Performs investigational product inventory
- Ensures return of unused materials to designated location or verifies destruction as required
- May serve as mentor for new clinical study monitors
- Implementing action plans for sites not meeting expectations
- Ensuring compliance with SOPs, local regulations, and ICH and GCP guidelines
- Assists project manager or clinical team manager on assigned projects
- Providing trial status tracking and progress update reports to Project Manager as required
- Other tasks and responsibilities as needed.
RESEARCH ASSOCIATE
CADILA HEALTHCARE LTD.
AHMEDABAD
04.2020 - 06.2021
- Assures timely reporting of AEs/ SAEs and Protocol Violations to EC/IRB and Regulatory
- Preparation of study documents dossier for EC/IRB and Regulatory submission
- Ensure IEC/IRB has been regularly updated about study development as per requirement
- Regularly performs Investigational Product (IP) accountability
- Review status of contents of site Regulatory Binder/ISF
- Ensures timely collection/uploading of essential documents into eTMF as per requirements
- Ensure readiness of site for Internal/external audits and facilitates auditor as and when required
- To perform Site Feasibility, Site Qualification, Site Initiation, Monitoring, and Closeout Visits
- Plan and execute site initiation visits and training activities for site staff (Study coordinator, Pharmacist, Co-Investigator, and PI)
- ICH GCP training to site staff and collection of training logs and ensure regular training of study staff during conduct of study as well
- Perform monitoring visits according to monitoring plan, prepare site monitoring reports and finalize within set timeline
- Performs source document verification (SDV) according to contractual requirements
- Ensures timely completion and submission of CRFs according to Clinical Monitoring Plan (CMP) and/or Data Management Plan (DMP)
- Assures timely and accurate completion of Data Clarification Forms (DCFs)
- Ensures compliance with all protocol requirements
- Assures effective patient identification and recruitment plan is in place.
- Gathered, arranged, and corrected research data to create representative graphs and charts highlighting results for presentations.
- Helped team meet regulatory requirements by coordinating documentation and filings.
SENIOR SCIENTIFIC ASSISTANT
CADILA HEALTHCARE LTD
AHMEDABAD
11.2017 - 04.2020
- Collaborate with Project Manager to select sites, develop project plans and Assist in designing of clinical trials
- Support Clinical Sites and served as primary sponsor contact when Project manager was unavailable Ensuring clinical trials maintain their integrity by following ethical practices and legal regulations
- Tracking of recruited and screened people to participate in clinical trials
- Follow up with Clinical Operations for Data entries, source data verification, and query resolution in EDC
- Review monitoring visit reports
- Review study drug accountability documentation
- Maintain documents to electronic and paper TMFs and participate in TMF audits
- Process and track vendor invoices and investigator grant payments
- Organize and tracking of purchase orders from finance department
- Distribution, tracking, and execution of site CTAs and CDAs with assistance from legal department
- Collection, maintaining and reviewing essential and non-essential documentation
- Coordinate packaging, shipping, and tracking of study supplies and materials Monitor study progress and enforce deadlines
- Update and manage several project deadlines
- Develop and maintain system for receipt, tracking, and archiving of clinical trial documentation
- Provide support at start-up, maintenance, and close-out activities for investigation sites, specifically as these pertain to records management
- Draft Meeting agendas and meeting minutes
- EC Dossier submission and any updated document notification to ECs
- Coordination with QC and QA team to compliance queries related to study
- Logistic Support for Supply study documents and IP
- Additional site notification to DCGI and other regulatory submissions (e.g., Annual Study status, PI change)
- Study Update in CTRI
- Presentation and study documents preparation e.g., TMF Plan, Lab manual, study Protocol, ICH GCP Coordination with Lab and Lab data review and maintain tracking
- Assist to Data Management team for SAE Management
- SIV Submissions.
- Demonstrated high level of initiative and creativity while tackling difficult tasks.
RESEARCH ASSOCIATE
CADILA PHARMACEUTICAL LTD
AHMEDABAD
06.2016 - 09.2017
- Act as Point of Contact between sponsor, operation team, and sites
- Prepared and submitted Ethics Committee Dossier to ECs
- Study-specific Site feasibility form executed
- Maintained and Updated Trial Master File
- Presentation prepared e.g., Study Protocol, ICH GCP
- Reviewed Site Initiation and Monitoring reports
- CTAs & CDAs execution
- Gathered, arranged, and corrected research data to create representative graphs and charts highlighting results for presentations.
- Helped team meet regulatory requirements by coordinating documentation and filings.
Education
MASTER - PHARMACY
K B INSTITUTE OF PHARMACEUTICAL EDUCATION AND RESEARCH
GANDHINAGAR 07.2014 - 05.2016
BACHELOR - PHARMACY
SHREE SWAMINARAYAN SANKAR PHARMACY COLLEGE
ZUNDAL 06.2010 - 05.2014
Skills
Experienced in assisting on clinical research projects
Good understanding of the clinical trial methodology and extensive knowledge of ICH GCP
Worked with CTMS (Clinical Trial Management System), IWRS, and EDC
Familiar with the experimental procedures and medical terminology
Microsoft OfficePossess strong communication skills
Ease of multi-tasking and troubleshooting
Ability to maintain the essence of a professional at work
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Timeline
CLINICAL RESEARCH ASSOCIATE
LET’S EVOLVE LIFE PVT. LTD
08.2021 - 10.2022
RESEARCH ASSOCIATE
CADILA HEALTHCARE LTD.
04.2020 - 06.2021
SENIOR SCIENTIFIC ASSISTANT
CADILA HEALTHCARE LTD
11.2017 - 04.2020
RESEARCH ASSOCIATE
CADILA PHARMACEUTICAL LTD
06.2016 - 09.2017
MASTER - PHARMACY
K B INSTITUTE OF PHARMACEUTICAL EDUCATION AND RESEARCH
07.2014 - 05.2016
BACHELOR - PHARMACY
SHREE SWAMINARAYAN SANKAR PHARMACY COLLEGE
06.2010 - 05.2014