Clinical Research Program Manager
About The Position
The Clinical Research Program Manager (CRPM) is a specialized, independent research professional responsible for the operational management and oversight of all local Shriners Children’s (SHC) clinical research activities. Reporting to the Hospital Administrator/Clinic Director and the Research Programs Office at SHC International Headquarters, the CRPM provides support and leadership in accordance with SHC’s policies and procedures, hospital regulations, the Code of Federal Regulation, and Good Clinical Practice guidelines. The CRPM collaborates closely with the Chief of Staff, SHC scientific and medical staff, and other research personnel to ethically recruit and consent SHC’s vulnerable pediatric subjects and to appropriately collect and safeguard data. The CRPM serves as the site’s primary liaison among research participants, local study staff, the local investigator(s), and study sponsor(s), ensuring proper study conduct, subject safety, and the quality of data and data safeguards. This position manages the day-to-day operations of the clinical research program, ensures competent and standardized staff practices, and coordinates strategies to enhance interdisciplinary communication and collaboration. For sites with multiple Clinical Research Coordinators (CRCs), the CRPM is responsible for their direct oversight and reporting.
Requirements
- Without a Bachelor's degree, 5 or more years of specific job-related experience in the administration of clinical research.
- 3 or more years Clinical research experience, e.g. experience with site management, study management, IRB's and federal regulations regarding clinical research compliance.
- Basic Life Support (BLS)
Nice To Haves
- Bachelor or Master's in Clinical Research, science or other healthcare related field.
- Experience in the coordination of intergroup or multi-site clinical studies.
- CCRP or CCRC certification.
Responsibilities
- Accountable for the site’s research activities.
- Facilitates the local site’s research programs and projects through collaborative, timely communications and teamwork.
- Coordinates with the Department of Research Programs regarding clinical research activities, including OnCore, audits, and regulatory compliance issues.
- Proactively collaborates with the Department of Research Programs to train and support research staff, including the development of work aides, templates, guidelines, policies, and initiatives aimed at improving process and efficiency.
- Provides support, direction, supervision, and mentoring for any site clinical research coordinators, promoting exemplary study conduct, subject safety, and the generation of accurate and complete substantiated data within SHC’s data safeguards.
- Supports the implementation of approved research protocols.
- Ensures studies are conducted in compliance with the approved protocol, Good Clinical Practice (GCP) guidelines, applicable regulatory requirements, SHC policies and standards.
- Performs study-specific research activities and/or interventions, within the bounds of professional licensure.
- Verifies data accuracy through internal quality control measures to confirm reported study data is accurate, complete, and verifiable from source documents.
- Provides timely responses to data queries; reviews source documents and addresses data discrepancies.
- Participates in timely and thorough data cleaning and database lock procedures in preparation for data analysis.
Benefits
- Compensation is determined based on years of relevant experience and departmental equity.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
