Rekha Gopal
Fairfax,VA
Summary
Regulatory Specialist with extensive experience at Inova Health Systems, specializing in regulatory submissions and compliance. Demonstrated ability to enhance study integrity and efficiency through strong analytical and problem-solving skills. Proven success in fostering collaboration among cross-functional teams, resulting in reduced study start-up times and improved audit readiness.
Overview
16
16
years of professional experience
1
1
Certification
Work History
Regulatory Specialist
Inova Health Systems
Falls Church, VA
08.2022 - Current
- Lead regulatory specialist for clinical research, ensuring compliance with regulations.
- Prepare and manage regulatory documents from initiation to close-out.
- Collaborate with IRBs, sponsors, and agencies for study communications.
- Primary contact for reliance agreements, and contract execution.
- Guide the team on compliance, mentor new hires, and support protocol submissions.
- Orchestrated collaboration with IRBs and sponsors, facilitating seamless communication, and significantly reducing study start-up times..
- Maintained comprehensive electronic regulatory binders, ensuring meticulous documentation that supports audit readiness and regulatory compliance.
- Guided and trained team members on research compliance, fostering a culture of accuracy and accountability within the clinical research team.
- Actively participated in internal and external audits, crafting CAPAs, and effectively addressing audit observations to strengthen regulatory processes.
- Led compliance initiatives for clinical research, ensuring adherence to regulations, and enhancing overall study integrity.
- Analyzed regulatory requirements to streamline document management, resulting in improved efficiency and reduced processing times.
Clinical Research Coordinator
Lysosomal and Rare Disorder Research and Treatment Center
Fairfax, VA
09.2019 - 08.2022
- Coordinated and performed all aspects of clinical research activities for drug and gene therapy trials.
- Executed contracts, negotiated budgets, responsible for invoices, and study start-up activities.
- Managed and performed study visits and liaised between participants and study-related parties.
- Prepared source documents and study logs, performed data collection and entry using EDC platforms, answered queries, scheduled and attended monitoring visits.
- Responsible for regulatory submissions to IRBs and Institutional Biosafety Committees (IBC), reporting AEs/SAEs and protocol deviations, and preparing closeout reports.
- Completed feasibility questionnaires and scheduled and attended SQV, SIV, and closeout visits.
- Assisted in preparing for FDA audits and responded to audit observations.
- Hired and trained the new hires for the study, coordinating activities and protocols.
- Attended investigator calls and meetings.
- Orchestrated cross-functional meetings to align study protocols and participant engagement strategies, fostering a unified approach to clinical trials.
- Presented findings to stakeholders, successfully advocating for resource allocation that led to improved trial efficiency and participant recruitment.
- Mentored new hires on study protocols and best practices, cultivating a knowledgeable team and enhancing overall research capabilities.
- Coordinated clinical research activities for drug trials, enhancing participant engagement and achieving measurable improvements in recruitment timelines.
- Executed regulatory submissions and managed adverse event reporting, ensuring compliance and safeguarding participant safety throughout the study lifecycle.
Pharmacy Technician
CVS Pharmacy
Falls Church, VA
08.2018 - 09.2019
- Advanced prescription processing while efficiently managing inventory.
- Initiated practical leadership skills by providing quality training for new hires.
- Worked closely with pharmacists and used medication input software to dispense medication accurately.
- Processed prescriptions with precision, ensuring timely delivery and enhancing customer satisfaction through increased accuracy.
- Partnered with pharmacists to streamline medication dispensing, improving workflow efficiency and reducing waiting times for patients.
- Monitored inventory levels and implemented reordering protocols, achieving substantial improvements in stock availability and minimizing shortages.
- Provided hands-on training for new hires, fostering a collaborative environment and enhancing team productivity.
- Maintained meticulous records of medication dispensation, upholding compliance with regulatory standards and ensuring patient safety.
- Executed accurate prescription processing, ensuring timely delivery and enhancing customer satisfaction through increased accuracy.
Clinical Trial Management Intern
Sollers
Edison, NJ
03.2019 - 08.2019
- Knowledge of Clinical Trial Phases, Contracts and Budgets, Vendor management, Stakeholder engagement, Trial Designs, and Roles and Responsibilities.
- Familiarized with Site Selection, Site Management, Site Initiation to Closeout, Trial Monitoring, Source Data Verification (SDV), Standard Operating Procedures (SOPs), Quality Assurance, Audits, Site Master Files (SMF) and Trial Master Files (TMF).
- Received hands-on experience in IVRS/ IWRS, Data cleaning, writing queries, reviewing regulatory binders, and data verifications using the CTMS tool.
- Attended Investigator meetings and conferences.
Clinical Research Associate
Micro Therapeutic Research Labs (CRO)
Chennai, India
12.2009 - 01.2013
- Involved in bioavailability and bioequivalence studies in clinical research for developing generic drugs.
- Screened subjects for eligibility using protocol-specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion.
- Completed and Maintained the source documents and made them ready for monitors to verify the source data.
- Conducted bioavailability studies, ensuring rigorous adherence to protocols, which led to improved accuracy in data reporting and regulatory compliance.
- Screened potential subjects for clinical trials, enhancing participant selection efficiency and contributing to timely study initiation.
- Maintained comprehensive source documents for clinical trials, facilitating smooth monitoring processes and upholding data integrity.
- Worked closely with cross-functional teams to streamline the study processes, fostering an environment of shared knowledge and timely results.
- Demonstrated strong interpersonal skills in managing participant communications, ensuring a positive experience throughout the study.
Education
Master of Science - Healthcare Management
Stevenson University
Owings Mills, MD08-2025
Master of Science - Biochemistry
Bharathiyar University
India04-2008
Bachelor of Science - Biochemistry
Bharathiyar University
India04-2006
Skills
- Regulatory submissions
- Trial master file (TMF)
- Clinical trial management systems (CTMS)
- Institutional review board (IRB) platforms
- Electronic data capture (EDC)
- Data management
- Problem solving
- Analytical skills
Certification
• Certified Clinical Research Professional – SOCRA 2022
• Clinical Trial Management System Certification, Sollers, Edison, New Jersey. 2019
• Clinical Trial Management System Certification, Sollers, Edison, New Jersey. 2019
Speaking Engagements
- Delivered an early study communication strategies as a panel speaker in "Brainstorm early communication strategies that set studies up for success" - 5th Investigator Initiated Trials Conference, Dynamic Global Events, Philadelphia, PA, Nov 2025.
Timeline
Regulatory Specialist
Inova Health Systems
08.2022 - Current
Clinical Research Coordinator
Lysosomal and Rare Disorder Research and Treatment Center
09.2019 - 08.2022
Clinical Trial Management Intern
Sollers
03.2019 - 08.2019
Pharmacy Technician
CVS Pharmacy
08.2018 - 09.2019
Clinical Research Associate
Micro Therapeutic Research Labs (CRO)
12.2009 - 01.2013
Master of Science - Healthcare Management
Stevenson University
Master of Science - Biochemistry
Bharathiyar University
Bachelor of Science - Biochemistry
Bharathiyar University