Clin Res Coord FSM/CC
Coordinates and guides the review and approval process of research activities associated with clinical research studies of low to moderate complexity involving human subjects ensuring the protection of their safety, rights, and welfare. Interprets and applies rules and regulations (NU, local, state, federal, industry, sponsor, etc.) and recommends and guides principal investigators (PIs) and research staff in the creation, submission, documenting, reporting, etc. of study activities ensuring appropriate compliance.
- Note: Not all aspects of the job are covered by this job description.
- Researches, interprets and applies rules and regulations (NU, local, state, federal, industry, sponsor, etc.) and recommends and guides principal investigators (PIs) and research staff in the creation, submission, documenting, reporting, etc. of study activities
- Provides regulatory support for multiple clinical research studies, which may involve multi-centered cooperative group studies, single site studies, intergroup studies, industry studies, and investigator-initiated studies. Maintains regulatory requirementsof relevant national trials registries. a Maintains documentation requirements, protocols, and approvals via multiple databases, systems and vehicles.
- Guides and coordinates all relevant submissions, documentation, reporting processes, communications, and audits (new study applications, renewals, revisions, modifications, amendments, adverse events, safety reports, close-out, etc.), recommending alternatives to ensure compliance and approval for internal and external constituencies
- Updates all systems, including registrations and training databases for faculty and staff
- Serves as regulatory contact and/or resource to internal and external constituencies as appropriate. Acts as liaison between research staff (PI, faculty, RNs, technicians, etc.), and internal/external regulatory and oversight groups (NU’s IRB, sponsors (NIH, industry), government agencies, etc.) to resolve issues and problems, negotiate compromises, and offer alternatives and recommendations to facilitate and expedite research while ensuring compliance
- Provides training and limited oversight/guidance to junior staff with regards to regulations, policies, protocols, and systems
Minimum Competencies: (Skills, knowledge, and abilities.)
- Bachelor’s degree in relevant area of study required
- One year of work experience in a regulatory and/or medical research environment from which a strong knowledge of clinical research protocols has been gained
- Demonstration of regulatory knowledge including familiarity with Code of Federal Regulations and Good Clinical Practice guidelines
- Excellent critical thinking, consultative, verbal and written communication skills required
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Professional Growth & Development:
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