Medix seeks a Clinical Research Manager to provide leadership and oversight of multiple clinical research projects in hematology. The Clinical Research Manager will be working in hematology. The Clinical Research Manager is responsible for supervising multiple clinical research staff along with managing clinical research operations, including quality management, personnel management, regulatory compliance, and fiscal oversight.
Provide leadership and oversight of one large or multiple small clinical research projects. Supervise multiple clinical research staff. Manage clinical research operations, including quality management, personnel management, regulatory compliance, and fiscal oversight.
-Hire, orient, train, and conduct performance reviews for staff handling research administration activities associated with the conducting of clinical trials.
-Monitor staffing levels, and identify adequate coverage for trial workload across teams of study coordinators.
-Audit operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes.
-Monitor Institutional Review Board submissions, and respond to requests and questions.
-Provide leadership and expertise in identifying and completing research grants.
-Oversee financial resources, as needed, create internal and external budgets for research protocols, assure financial accountability, and serve as primary liaison between sponsor, department accounting, and Research Management Group
-Coordinate new protocol submissions, renewals, and revisions to Institutional Review Board for multiple studies. Complete annual reports to Institutional Review Board, CSTA, FDA and other regulatory agencies. Submit Investigational New Drug applications to the FDA as required.
EDUCATION & EXPERIENCE (REQUIRED):
Bachelor's degree in related field and five years of experience in clinical research, or an equivalent combination of education and relevant experience. Master's degree preferred.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
•Excellent interpersonal skills.
•Proficiency in Microsoft Office and database applications.
•Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices.
•Knowledge of medical terminology.
•Demonstrated managerial experience; such as two or more years of supervisory experience.
CERTIFICATIONS & LICENSES:
Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.
Good Clinical Practice