CLINICAL RESEARCH REGULATORY COORDINATOR - HOAG CENTER FOR CLINICAL RESEARCH

Salary Range: $33.9100 - $52.1700 /hour. Actual compensation may vary based on geographic location, work experience, skill level, and education.

 

The Clinical Research Regulatory Coordinator supports clinical research teams (physicians, nurses, 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.

 

The Regulatory Coordinator ensures all research studies are compliant with regulations and maintains accurate and up-to-date regulatory files. The Coordinator is the central resource for staff conducting clinical research. Understands current regulatory requirements and ensures a smooth submission process to minimize delays to study initiation. Remains informed of current federal, state, and local regulations regarding clinical research and communicates any changes to study team.

 

Tracks each protocol through the IRB/subcommittee approval process, evaluates for recurrent problems, develops and implements systems to decrease delay in the approval process. Works closely with Investigators and Research Staff on new studies to ensure timely, accurate submissions to the IRB and sponsors.

 

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.

 

Produces and maintains 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 complete CDAs for new studies; assists with assigning study codes.

 

Completes the External Visitors Checklist to meet badge requirements for access to institution. Reviews informed consents for institutional language and works with legal and sponsors to ensure CTA language is consistent with consent.

 

Works with multiple IRBs and understands submission process and requirements. Provides institutional authorization for new submissions with WIRB.  Communicates and maintains working relationship with WIRB ensuring institutional needs are met per Master Services Agreement. Provides study, enrollment updates, and SAE reports to Clinical Research Oversight Committee. Work with Investigators to renew NCI/CTEP applications. Participates in all investigator meetings, as required.

 

Maintains working knowledge of current protocols and internal SOPs. Assists with the coordination and review of amendments, annual reports, safety reports, and other regulatory submissions required for maintenance of INDs or IDEs.

 

Education and Experience

• Associate Degree or equivalent education and experience required
• One (1) year of regulatory documentation experience in clinical research preferred
• Working knowledge of FDA, NIH, and OHRP regulatory requirements and ICH GCP guidelines preferred

 

Hoag is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Hoag is committed to the principle of equal employment opportunity for all employees and providing employees with a work environment free of discrimination and harassment. Hoag hires a diverse group of people in a manner that allows them to reach their full potential in the pursuit of organizational objectives.