POSITION SUMMARY:

Under the supervision of the Senior Regulatory Manager, the Regulatory Assistant is responsible to ensure the maintenance of regulatory documentation for the portfolio of studies within the program. This person prepares and submits IRB continuing review reports, amendments, revisions, deviation reports, protocol exceptions, CAPAs, new information and unanticipated events and safety reports to local and central IRBs for Industry sponsored and NCI- sponsored clinical trials.

Position: Clinical Research Coordinator - Regulatory Assistant

Department: Cancer Care

Schedule: Full Time

ESSENTIAL RESPONSIBILITIES / DUTIES:

Maintain basic regulatory documents across all studies within the Cancer & Hematology Clinical Research Program, including, but not limited to:

• Curriculum Vitae, Medical Licenses, Good Clinical Practice Certifications, Research Licenses and renewals, NCI RCR and expiration tracking
• Delegation of Authority & Training Logs
• Monitoring Visit Logs
• IRB Continuing Review Submissions
• Safety Report tracking and submissions
• Deviation Reports
• Protocol Exception Reports
• Corrective Action Plan Submission
• Protocol Amendment Compilation and Submission
• Audit Preparation and Implementation

Meeting Scheduling:

• Pre-Study Visits
• Site Selection Visits
• Site Initiation Visits
• Monitoring Visits
• Monthly Sponsor Updates (as necessary)

Coordinates and is responsible for collaboration with representatives of pharmaceutical companies and/or CROs as required for site feasibility visits, site initiation visits, all monitoring/audit visits, and study close out visits for all industry, investigator initiated, NCI, AMC and RTOG studies. This person carries out study preparation for investigator meetings, site training, tracking of these activities, as well as resolves queries raised by other study teams and CROs.

Maintains regulatory binders with the above documents as well as IRB approvals and study-related correspondence for each protocol from pre-activation through close-out, making sure to update each document as information changes or the document expires.

Submits and maintains up to date documentation for investigator research licenses along with submission of annual NCI Investigator renewal packets (RCR) to the FDA for each investigator, including FDA Form 1572, Financial Disclosure Form, Supplemental Investigational Data Form and curriculum vitae.

Maintain current certifications in Good Clinical Practice, the Protection of Human Subjects and HIPAA, CVs, IND research licenses

Create, maintain, and archive clinical study documentation, TMFs in accordance with Standard Operating Procedures, Good Clinical Practice ICH-GCP guidelines and FDA regulations.

Assists the Senior Regulatory Manager to perform Quality Control (QC) checks of paper and electronic Trial Master Files (TMFs) in preparation for internal audits and for audits by FDA, SWOG, NRG Oncology, or site monitors for industry-sponsored protocols. Ensures that the CH-CRP office is "audit-ready" at all times, with regard to regulatory documentation

Must adhere to all of BMC's RESPECT behavioral standards.

(The above statements in this job description are intended to depict the general nature and level of work assigned to the employee(s) in this job. The above is not intended to represent an exhaustive list of accountable duties and responsibilities required).

JOB REQUIREMENTS

• CRC I: Entry Level Position
  • Baccalaureate Degree Required AND 0-2 years experience

Req id: 29331