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 projectsundefined
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
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