Lead Coordinator - Research

Position Responsibilities

• Affords support to the Departmental Manager in managing the Regulatory department to align with established objectives, policies, and protocol requirements.
• Coordinates the work of support personnel in implementing regulatory requirements.
• Maintains oversight and monitors the regulatory department’s activities and clinical staff; implements standard policies and procedures related to compliance and Good Clinical Practices (GCP).
• Represents the research program at hospital, departmental, national, or local meetings as necessary.
• Provides creative leadership and customized solutions to meet the needs of the research program and affiliated institutions.
• Attends pre-study and site initiation visits and collaborates with program leadership on strategic planning.
• Participates in meetings with auditors and monitors to resolve any issues or queries.
• Develops and implements communication strategies and materials for internal and external audiences supporting program goals and objectives.
• Serves as a liaison for the implementation of hospital, federal, and regulatory agency policies and procedures to affiliated institutions.
• Reviews and approves all regulatory packets before submission to the Institutional Review Board (IRB) for review.
• Assists with the preparation for National Cancer Institute (NCI) and Food and Drug Administration (FDA) audits and sponsor audits.
• Supports research staff and physicians with regard to clinical protocols.

Qualifications

• License/Registration/Certification: Related field certification preferred.
• Education: College degree and/or technical degree preferred.
• Experience: One year of medical background required; research experience preferred.

Benefits

• Health benefits
• Life insurance
• Long-term disability coverage
• Healthcare spending accounts
• Retail retirement plan
• Paid time off
• Pet insurance
• Tuition reimbursement
• Employee assistance program
• Wellness program
• On-site housing for select positions and more!