Clinical Research Program Manager

Northwell•Village of New Hyde Park, NY

1d•$70,470 - $116,870

About The Position

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.

Requirements

Bachelor's Degree required, or equivalent combination of education and related experience.
1-3 years of relevant experience, required.

Nice To Haves

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

Responsibilities

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.
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