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Regulatory Coordinator
4 months ago
Description:
Responsibilities
The Regulatory Coordinator position coordinates and guides the review and approval processes of research activities associated with clinical research studies involving human subjects, and helps ensure the protection of their safety, rights, and welfare
Main role responsibilities include advising on, interpreting and applying rules and regulations (Central, local, state, federal, industry, sponsor, etc.), submitting and with recommending and guiding principal investigators (PIs) and research staff in the creation, submission, documenting, reporting, etc., of study activities ensuring appropriate compliance
The Regulatory Coordinator collaborates with the daily operations of the research study teams (biomedical &/or social-behavioral research studies) which can include multidisciplinary teams of colleagues, sponsors & other external project stakeholders
The role helps ensures that all study activities are completed in accordance with the Good Clinical Practice (GCP) & current local, state, & federal laws, regulations, guidance, policies & procedures developed by the Institutional Review Board (IRB), Food and Drug Administration (FDA) Code of Federal Regulations (CFR), & the International Conference on Harmonization (ICH)
This position has frequent interaction with physicians, sponsor contacts, Institutional Review Board staff, and study staff members, and interpersonal communication, strong writing skills, and organizational skills are necessary to being successful in this position
Determines and interprets applicable rules and regulations associated with clinical research studies and trials involving human subjects ensuring the protection of their safety, rights, and welfare
Guides and coordinates all associated submission, documentation, and reporting processes (new study applications, renewals, revisions, modifications, amendments, adverse events, safety reports, close-out, etc.) recommending alternatives to ensure compliance and approval
Acts as liaison between research staff (PI, faculty, nurses, technicians, etc.), and internal/external regulatory and oversight groups (IRB, sponsors (NIH, industry), government agencies (FDA), etc.)
to resolve issues and problems, negotiate compromises, and offer alternatives and recommendations to facilitate and expedite research while ensuring compliance
Determines compliance required documentation and drafts necessary items such as protocols, informed consent, etc
Ensures accuracy of IRB approval letters with respect to sponsor information and NIH grant identifiers
Provides guidance and training to research staff to ensure compliance with complex, highly specialized rules and regulations associated with clinical research studies and trials involving human subjects
Creates reports, summaries and analysis in regard to compliance requirements recommending changes in practice or procedure to increase effectiveness and efficiency of compliance
Alerts appropriate staff to changes and ensures appropriate interpretation and application to new and existing studies and trials
Skills:
Regulatory, Clinical Research, IRB submission, review, audit, regulatory compliance, federal regulation, CITI, gcp
Top Skills Details:
Regulatory, Clinical Research, IRB submission, review, audit
Additional Skills & Qualifications:
-Bachelor's Degree required
- at least 1 year of hands on regulatory experience at a site level
- need to have managed at least 4-5 studies from a regulatory perspective
-experience with advarra, Ereg, Complion (that's what they use), Florence is usually key
Experience Level:
Intermediate Level
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
+ Hiring diverse talent
+ Maintaining an inclusive environment through persistent self-reflection
+ Building a culture of care, engagement, and recognition with clear outcomes
+ Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
