Regulatory Affairs Specialist
We are currently searching for a Regulatory Affairs Specialist at (NIDA), Intramural Research Program (IRP), Office of the Clinical Director (OCD) that supports and facilitates the NIDA clinical research program through leadership oversight of clinical research practice, provision of critical infrastructure support such as protocol review and monitoring. Training of clinical research personnel, data management, biostatistics for trial design and analysis, auditing, monitoring of intramural trials, outreach to promote patient accrual and data collection and storage. This is a full-time, on-site opportunity in Baltimore, MD.Duties & Responsibilities
- Monitor key ethical and legal issues related to protection of research participants, adherence to policies for the appropriate use of biospecimens, and adherence to federal and state regulations surrounding the collection, storage, dissemination, and use of biospecimens.
- Aid with all aspects of the protocol lifecycle including initial Investigational New Drug/Device (IND/IDE) submission, Institutional Review Board (IRB) submission of protocols, continuing review applications, protocol amendments, annual reports, protocol inactivation with IRB and other regulatory bodies.
- Review documents for content, accuracy, and compliance with applicable regulations prior to submission to regulatory agencies.
- Serve as a Quality Assurance/Quality Improvement (QA/QI) monitor for the CD and the Clinical Investigators reviewing data collection to provide regulatory guidance, review, and expertise to ensure documentation conforms to applicable regulations and guidelines.
- Tracks the review process and maintains detailed, complete, and accurate records for each protocol of the approvals at the various stages of the review process, including new protocol submissions, amendments to protocols, and continuing reviews.
- Assist primary investigators and clinical supervisors obtain and maintain government approval for drugs, medical devices, nutritional products and related healthcare materials.
- Collaborate with primary investigators or project teams to ensure awareness of and compliance with all manner of government regulation.
- Prepare documentation, manage information, and maintain files and data repositories securely and in accordance with regulatory standards.
- Assist editors draft product and procedure language for regulatory accuracy and completeness.
- Document regulatory compliance actions and track progress against predetermined project plans and schedules.
- Works closely with the NIDA Records Management Office in establishing and maintaining a paperless automated document management and tracking system for NIDA protocols.
- Compile and maintain IND/IDE Sponsor regulatory files throughout the lifecycle of sponsorship.
- Adhere to standard operating procedures for quality assurance and monitor quality assurance standards.
- Obtain continuing education about current regulatory issues with the Food and Drug Administration (FDA), Sponsor, Office for Human Research Protections, and other regulatory bodies.
- Serve on NIDA IRP-wide QA/QI committees toward improving patient safety and research integrity e.g., Intramural Research Protocol Audit Committee (IRPAC).
- Consults with clinicians and research teams, IRB personnel, Clinical Investigators, contractors, research sponsors, and regulatory personnel regarding regulatory issues, requirements, protocol adherence and interpretation.
- Provide guidance and leadership for the establishment of regulatory standards and templates for regulatory documents.
- Master’s degree in Multi-Disciplinary or General Science
- Institutional Review Board (IRB) Practice Experience
- Human Research Protection Program (HRPP) Certifications
- Good Clinical Practice (GCP) Certifications
- 1-2 years experience
- Oral and written scientific communication
- Excellent Inter-personal skills
- Advanced time management and organization
- Microsoft Office Suite Proficiency
- Data Base Management
Dovel Technologies and its Family of Companies (Medical Science & Computing and Ace Info Solutions) was acquired in October 2021.
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