Clinical Trials Regulatory Coordinator

Clinical Trials Regulatory Coordinator

The Clinical Research Regulatory Coordinator will support clinical research teams (research physicians, research nurses, research coordinators etc.) in research efforts by facilitating the study start-up approval process and maintaining documentation of regulatory compliance throughout the trial's duration for research studies involving human subjects. S/he will be responsible for ensuring that all research studies are compliant with regulations as well as maintain accurate and up-to-date regulatory files. S/he will serve as a central regulatory resource for staff conducting clinical research. This position reports to the Director, Clinical Research.

Essential Functions:

• Works closely with Investigators and Research Staff on new studies to ensure timely, accurate submissions to the IRB and sponsors.

• Understands current regulatory requirements and ensures a smooth submission process to minimize delays to study initiation.

• Works with multiple IRBs and understands their submission process and requirements.

• New study submissions to the regulatory authorities, IRB, and sponsors including initial submissions, amendments, safety reports, deviations, etc. to ensure timely, accurate submissions. Maintains staff credentials including the CV, licenses, FDQ, etc. Serves as primary IRB contact & provides institutional authorization for new submissions.

• Tracks each protocol through the IRB/subcommittee approval process, evaluates for recurrent problems, develops and implements systems to decrease the delay in the approval process.

• Works with sponsors to ensure all proper regulatory documents are approved and that all documents, access to CRF and databases, monitoring/auditing requirements have been completed prior to the start of a study.

• Will produce, as applicable, and maintain regulatory binders prior to studies starting with all required documents and ensure dedicated electronic study folder is current.

• Obtains and completes all required documents for new submissions, exemption requests, compassionate uses, amendment applications, continuing review, and closure activities.

• Reviews and completes CDAs for new studies; assists with assigning study codes.

• Reviews informed consents for institutional language and work with legal and sponsors to ensure CTA language is consistent with consent.

• Provides study, enrollment updates and SAE reports to Director, Clinical Research.

• Remains informed of current federal, state, and local regulations regarding clinical research and communicate any changes to the study team.

• Maintains working knowledge of current protocols and internal SOPs. Assists in the development and maintenance of SOPs including work instructions, forms, and templates. Develops forms, checklists, and other tools to facilitate study completion and compliance.

• Communicates regularly with Research Staff to review data accuracy, clinical data quality, and overall study progress. Participates in required teleconferences, on-site meetings, and off-site investigator meetings, as required.

• Documents and tracks research training of investigators and research staff.

• Performs other duties as assigned.

Education:

• BA/BS degree preferred.

Certification/License:

• ACRP/SoCRA (or equivalent) certification preferred.

Experience:

• Two (2) years minimum of directly related experience, or equivalent combination of education and experience.

• Working knowledge of FDA, NIH, and OHRP regulatory requirements and ICH GCP guidelines.

Other Qualifications Required:

• Excellent communication skills and superb attention to detail.

• Excellent interpersonal skills and customer service focus is required.

• Strong writing and organizational skills. • Able to work in a fast-paced environment with flexibility and autonomy.

• Must be able to prioritize tasks on a daily basis.

• Computer knowledge in Microsoft Windows applications including Word, Outlook, and Excel and familiarity with electronic data capture systems.

Preferred Qualification:

Knowledge of oncology and hematology preferred. Knowledge in working in the oncology clinical trials preferred.