Research Regulatory Coordinator
About The Position
The Clinical Research Regulatory Coordinator is a specialized research professional that facilitates and coordinates the regulatory aspects of a clinical trial and plays a critical role in the conduct of research at Carle. This role is responsible for preparing, completing, and submitting required forms and documents, in consultation with the research team, to meet regulatory, IRB, and HIPAA guidelines and policies, at the time of initial review, modifications, and continuing review. The Clinical Research Regulatory Coordinator performs Informed Consent review and modifies consent form/HIPAA language while working with sponsors and IRBs for all studies to conform to Carle institutional guidelines.
Requirements
- Certified Clinical Research Professional (CCRP) within 3 years - Society of Clinical Research Associates (SOCRA)
- Related Field; Bachelor's Degree: Related Field
- Related field
Responsibilities
- Prepares, completes, and submits required forms and documents, in consultation with the research team, to meet regulatory, IRB, and HIPAA guidelines and policies, at the time of initial review, modifications, and continuing review.
- Performs Informed Consent review and modifies consent form/HIPAA language while working with sponsors and IRBs for all studies to conform to Carle institutional guidelines.
- Ensures consent language matches the research contract, budget, and protocol.
- Completes, submits, and maintains regulatory documents as applicable (including 1572s, Delegation of Authority logs, Financial Disclosure Forms, Consent Forms, and trainings) for industry sponsored as required.
- Prepares for and participates in external sponsor/monitor visits.
- Prepares for and participates in internal/external audits to ensure regulatory compliance and implement corrective and preventive action plans as needed.
- Updates and maintains current protocol information on the Research website.
- Distributes protocol documents to appropriate researcher and PI for review, approval, and implementation.
- Tracks study approvals and expirations to ensure uninterrupted project approval.
- Maintains regulatory database and manages electronic filing of all regulatory documents.
- Creates, submits, and maintains complete documentation to comply with research base regulatory requirements for oncology federally funded research projects
- Trains/assists new/seasoned Staff on regulatory process including CITI training, Study start-up, IRB submissions, maintaining a Study, and ensuring all essential documents are correct to submit to monitor/sponsor.
- Advises on remedies and revisions, in collaboration with the coordinator and/or investigator, and resolves any procedural issues that might arise in order to ensure timely IRB review
- Updates and maintains the active informed consent documents and HIPAA authorizations that are being utilized in projects in which subjects are consented (whether Carle research is assisting with consenting or not)
- Notifies appropriate staff, physicians, investigators and affiliates of protocol activations and closures in a timely manner
- Facilitates study closure in collaboration with investigator, research coordinator, and sponsor
- Applies rules and regulations (Carle local, state, federal, industry, sponsor, etc.), in collaboration with the Sr Clinical Research Regulatory Coordinator, and recommends and guides principal investigators (PIs) and research staff in the creation, submission, documenting, reporting, etc. of study activities ensuring appropriate compliance
- Monitors Investigator Initiated IRB-deferred studies, exempt and non-engaged projects for by ensuring regulatory documentation is current and maintained , including any IRB approvals
Benefits
- Comprehensive benefits package
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
