Megha Patel
Vadodara
Summary
Skilled clinical research coordinator with background in managing and overseeing clinical trials. Experience includes coordinating with research teams, ensuring compliance with protocols, and managing participant recruitment and data collection processes. Possess strong organizational skills, ability to manage multiple tasks efficiently, and capability to ensure accuracy in documentation and reporting. Contributed to improving trial procedures and enhancing data integrity in previous roles.
Overview
17
17
years of professional experience
Work History
Head of Clinical Research Department
Rhythm Heart Institute
Vadodara
01.2017 - Current
- Collaborated with internal departments such as Regulatory Affairs, Data Management, and Biostatistics to ensure timely completion of studies.
- Served as a liaison between sponsors, investigators, vendors throughout the duration of the study.
- Maintained accurate records of study documents including CRFs, informed consents, laboratory results.
- Organized, analyzed and modeled study data.
- Prepared financial reconciliation statements for each site involved in the trial.
- Adhered to standards in areas involving data collection, research protocols, and regulatory reporting.
- Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.
- Organized investigator meetings, prepared agendas, collected presentations, and took minutes at meetings.
- Trained new team members on the principles of Good Clinical Practice and ICH regulations.
- Developed and maintained regulatory documents for clinical trials.
- Participated in safety review boards to evaluate the safety profile of investigational products.
- Performed quality control checks on eCRF data by reviewing discrepancies reported by Data Management staff or generated from database queries.
- Managed the development of study materials such as questionnaires or training manuals.
- Ensured that all research activities were conducted according to protocols and in compliance with local laws and regulations as well as GCP guidelines.
- Collaborated closely with team members to achieve project objectives and meet deadlines.
- Demonstrated strong problem-solving skills, resolving issues efficiently and effectively.
Sr. Study Coordinator
Rhythm Heart Institute
Vadodara
01.2012 - 12.2016
- Developed and maintained study timelines for multiple studies.
- Assisted in preparation of submissions for Institutional Review Board approval process.
- Kept patient care protocols and clinical trial operations in compliance.
- Adhered to standards in areas involving data collection, research protocols, and regulatory reporting.
- Educated participants on studies and anticipated outcomes.
- Conducted screening interviews to determine eligibility of possible subjects.
- Reviewed patient medical records for completeness and accuracy according to protocol specifications.
- Collected, processed and delivered specimens from trial participants.
- Served as primary contact between sponsor companies and investigators throughout each stage of the trial process.
- Monitored subject enrollment and tracked dropout details.
- Took vital signs and collected medical histories as part of study protocols.
- Ensured compliance with Good Clinical Practices guidelines throughout all stages of clinical trials.
- Created reports summarizing patient recruitment activities, enrollment numbers, and adverse events.
- Documented any changes made during a trial such as amendments or protocol deviations.
- Recognized by management for providing exceptional customer service.
Assistant Course Coordinator
Apollo Hospital Educational and Research Foundation
Gandhinagar
01.2012 - 01.2013
- Developed course content and materials to support the learning objectives.
- Assisted with the design of new curricula for courses as needed.
- Monitored compliance with academic policies regarding grading, attendance, and other matters related to courses.
- Met with parents and instructors to discuss student progress and behavioral or learning issues.
- Assessed student progress throughout their academic programs using a variety of assessment tools.
- Planned and facilitated relevant, needs-based professional learning tools, resources and educational materials to enhance teaching skills.
- Updated course descriptions in college catalogs annually.
- Represented organization at many job fairs each year.
- Conducted regular meetings with faculty members to discuss curriculum changes and updates as needed.
Study Coordinator
Concept Clinical Services
Surat
01.2008 - 01.2012
- Monitored subject enrollment and tracked dropout details.
- Educated participants on studies and anticipated outcomes.
- Served as primary contact between sponsor companies and investigators throughout each stage of the trial process.
- Took vital signs and collected medical histories as part of study protocols.
- Placed orders for medications to be used in studies.
- Collected, processed and delivered specimens from trial participants.
Education
Masters - Clinical Research
Cranfield University
United Kingdom (U.K.)01.2009
Certificate - Intellectual Property
WIPO Worldwide Academy
Geneva01.2009
Post Graduate Diploma In Clinical Research Management (PGDCRM) - Clinical Research
ICRI
Ahmedabad01.2008
B.Pharm - Pharmacy
AISSMS College of Pharmacy Pune University
Pune, Maharashtra01.2007
Skills
- Quality assurance
- Public speaking
- Trial management
- Adverse event tracking
- Trial oversight
- Clinical research ethics
- Good clinical practice
- Data analysis
- Investigational product management
- Investigator coordination
- Subject retention strategies
- Patient recruitment
- Research sops understanding
- Biostatistics
- Informed consent process
- Adverse event reporting
- Study monitoring
- Participant recruitment
- Clinical trial management
- Site management
- Good clinical practices
- Research experience
- Study protocols
- Records maintenance
Faxnumber
+91-265-2541006
Telephonenumber
+91-9727166471
Clinicaltrials
- Obesity, III, Study Coordinator, 2023
- Heart Failure, III, Study Coordinator, 2023
- Heart Failure, IV, Study Coordinator, 2022
- Covid-19, III, Study Coordinator, 2022
- Dyslipidemia, III, Study Coordinator, 2022
- Acute MI, III, Study Coordinator, 2022
- Covid-19, II, Study Coordinator, 2021
- Covid-19, III, Study Coordinator, 2020
- Dyslipidemia, III, Study Coordinator, 2020
- Asthma, III, Study Coordinator, 2019
- Acute MI, III, Study Coordinator, 2018
- Statin Intolerance, III, Study Coordinator, 2018
- Asthma, III, Study Coordinator, 2017
- COPD, IV, Study Coordinator, 2017
- Acute Heart Failure, III, Study Coordinator, 2016
- ACS with diabetes, III, Study Coordinator, 2015
- Dyslipidemia, III, Study Coordinator, 2014
Timeline
Head of Clinical Research Department
Rhythm Heart Institute
01.2017 - Current
Sr. Study Coordinator
Rhythm Heart Institute
01.2012 - 12.2016
Assistant Course Coordinator
Apollo Hospital Educational and Research Foundation
01.2012 - 01.2013
Study Coordinator
Concept Clinical Services
01.2008 - 01.2012
Masters - Clinical Research
Cranfield University
Certificate - Intellectual Property
WIPO Worldwide Academy
Post Graduate Diploma In Clinical Research Management (PGDCRM) - Clinical Research
ICRI
B.Pharm - Pharmacy
AISSMS College of Pharmacy Pune University
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