Clinical Research Program Manager

Job Description Leads clinical research activities within the department under the direction of a physician; exhibits technical and functional expertise in the area of research through the development of protocols, hypotheses and educational curricula. Coordinates daily activities of a designated study or group of studies and maintains industry, FDA, and granting agency relationships. Leads training of faculty physicians, residents, medical students and research staff on good clinical practice, IRB and regulatory and grant agency requirements. Job Responsibility * Oversees coordination of a designated study or group of studies and recruitment of subjects in research projects, implementation of study procedures, and the collection and processing of data; keeps accurate and up-to-date records. * Identifies and pursues extramural funding opportunities through pursuit of grants and clinical trials; collaborates with physicians, investigators and other healthcare providers regarding subject care as necessary; promotes respect for subjects’ rights. * Maintains cooperative relations with drug companies and other research centers for information on new research interests. * Prepares manuscripts for publication in peer-reviewed journals and scientific meetings; engages physician leaders from various specialties to develop collaborative multidisciplinary research. * Liaises with agencies, pharmaceutical companies, laboratories, and equipment and supply companies as needed. * Oversees clinical research staff performing clinical functions i.e. phlebotomy, monitoring vital signs on study participants, etc. , when warranted; educates family and contributes to the care and evaluation of subjects, including determining preliminary inclusion/ exclusion criteria. * Oversees the administration of assessments as assigned and as related to study protocol; collects data, confers with PI and forwards results to sponsor (internal or external). * Operates under general guidance and work assignments are varied and require interpretation and independent decisions on course of action. * Performs related duties as required. All responsibilities noted here are considered essential functions of the job under the Americans with Disabilities Act. Duties not mentioned here, but considered related are not essential functions. Job Qualification * Bachelor's Degree required, or equivalent combination of education and related experience.

• 1-3 years of relevant experience, required.
• Experience assisting in protocol writing and informed consent development,

preferred * Working knowledge of FDA regulatory processes, including IND submissions, preferred

• Familiarity with ClinicalTrials.gov registration and maintenance, preferred
• Ability to manage multiple projects and collaborate across team, preferred
• Experience in an academic medical center or cancer research environment,

preferred Additional position responsibilities ay also include: * Collaborate with investigators to manage development of clinical trial protocols for oncology-based IITs * Draft, edit, and refine informed consent forms in alignment with regulatory, ethical, and institutional standards

• Provide input on study design, feasibility, and protocol optimization
• Additional Salary Detail

The salary range and/or hourly rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job advertisement and may be modified in the future.When determining a team member's base salary and/or rate, several factors may be considered as applicable (e.g., location, specialty, service line, years of relevant experience, education, credentials, negotiated contracts, budget and internal equity).