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Regulatory Coordinator
2 months ago
The Regulatory Coordinator is responsible for overseeing the day-to-day regulatory management of all types of clinical research protocols. The position will manage all aspects of study start-up, modification submissions, continuous reporting, and study close-out to the Institutional Review Board (IRB) and any relevant regulatory agencies.
Primary Responsibilities:
- Manage day-to-day regulatory operations and workload of regulatory team, plan resource needs and strategize growth.
- Provide regulatory support for research programs and oversee maintenance of all required regulatory documents.
- Provide regulatory start-up support for research teams for all types of clinical trials.
- Partner with study teams to provide ad hoc regulatory management for ongoing clinical trials.
- Oversee timely regulatory submissions to meet project timelines.
- Maintain Standard Operating Procedures (SOPs) and ensure procedural compliance.
- Identify program improvement opportunities and lead improvement efforts within team, including technology solutions; identify opportunities for expanding solutions to study teams.
- Coordinate with appropriate departments to address regulatory-related quality and compliance matters.
- Assist with the development of standard regulatory-related training requirements and with ongoing education and training for investigators and research personnel.
- Work with Quality Assurance to perform internal audits and quality assurance reviews on regulatory files, as needed.
- Liaise with appropriate personnel, departments and outside entities on clinical trial regulatory operations.
- Performing routine audits of research documentation such as
- proper informed consent of participants
- proper screening and recruitment methods
- adherence to the IRB approved study protocol
- accurate data collection and entry
- proper protection of participants' privacy and confidentiality
- accurate and timely reporting of adverse events and protocol deviations
- Assist sites with quality assurance i.e., create corrective and prevention action plan (CAPA) and note to file (NTF) documents etc.
- Submit protocol deviations, adverse events (AE) and severe adverse events (SAE) to IRB after discussing with Director of Clinical Research.
- Ensure receipt and filing of acknowledgments for deviations, AEs and SAEs.
- Ability to travel to local sites for monitoring purposes if need arises
- Bachelor's degree in Clinical Health Science/Healthcare Administration or a related field
- At least 2 years of Clinical Research Experience preferred
- Current and comprehensive knowledge of GCP, the International Conference on Harmonization (ICH) and FDA regulations
- Demonstrate good decision-making, positive judgment, attention to detail and follow through skills