Clinical Research Program Manager
About The Position
As our Clinical Research Professional, you will be instrumental in advancing medical knowledge by expertly managing and executing clinical trials. You will ensure the highest standards of data integrity, patient safety, and regulatory compliance throughout the research process. Every day you will manage trial activities, including participant recruitment, data collection, and documentation, serving as a key liaison for all stakeholders. You will ensure strict adherence to protocols and regulatory requirements from study initiation to completion. To be successful in this role, you will bring relevant clinical research experience and a strong understanding of regulatory guidelines (e.g., GCP, FDA). Your exceptional organizational skills, attention to detail, and ability to communicate effectively will be crucial in this dynamic field. Facilitates research activities in partnership with program Medical Director(s) and Research Administration colleagues leveraging clinical experience in related specialty area. Activities include coordination of grant submissions and sponsored clinical trials. Work includes management of site selection process, site initiation visits, and study submissions consistent with regulatory requirements and local policies. Directs, organizes and plans the daily research operational activities of the program and support staff to manage and grow the divisions research activities. Serves as the primary liaison for internal and external project sponsors, routinely informing key stakeholders of project plans, status updates, milestones (including subject enrollment metrics, timely data collection and submission and related contract and/or grant goals) through regular reporting and coordinated discussions. Manages program budget working synergistically with Research Administration to perform and coordinate transactional tasks; i.e., sponsor invoicing, patient financial billing, time and effort reporting, etc. Proactively manages supplies, staffing needs and research portfolio via forecasting reports to ensure a robust study pipeline is in place. Acts as the program fiscal steward and works to promote and grow the research portfolio thru public relations, web-based activities, newsletters and social media outlets. A strong working knowledge of GCP, ICH, DHHS, OIG and FDA regulations and depth of clinical expertise in the assigned area is required along with familiarity of all applicable federal and state regulations and institutional policies. Coordinates the process flow of a study from initial concept to IRB through the final study closure. Facilitates feasibility reviews based upon governing policies.
Requirements
- Relevant clinical research experience.
- Strong understanding of regulatory guidelines (e.g., GCP, FDA).
- Exceptional organizational skills.
- Attention to detail.
- Ability to communicate effectively.
- Bachelors Of Nursing, upon hire or Masters Other in healthcare related or business field.
- 4-6 years Minimum of five (5) years experience in related field.
- Three (3) years management experience.
- Registered Nurse: AZ, upon hire.
- Clinical Research Associate, within 12 - months.
Nice To Haves
- A strong working knowledge of GCP, ICH, DHHS, OIG and FDA regulations.
- Depth of clinical expertise in the assigned area.
- Familiarity of all applicable federal and state regulations and institutional policies.
Responsibilities
- Manage trial activities, including participant recruitment, data collection, and documentation.
- Serve as a key liaison for all stakeholders.
- Ensure strict adherence to protocols and regulatory requirements from study initiation to completion.
- Facilitate research activities in partnership with program Medical Director(s) and Research Administration colleagues.
- Coordinate grant submissions and sponsored clinical trials.
- Manage site selection process, site initiation visits, and study submissions consistent with regulatory requirements and local policies.
- Direct, organize, and plan the daily research operational activities of the program and support staff.
- Serve as the primary liaison for internal and external project sponsors, routinely informing key stakeholders of project plans, status updates, and milestones.
- Manage program budget working synergistically with Research Administration to perform and coordinate transactional tasks.
- Proactively manage supplies, staffing needs and research portfolio via forecasting reports.
- Act as the program fiscal steward and work to promote and grow the research portfolio.
- Coordinate the process flow of a study from initial concept to IRB through the final study closure.
- Facilitate feasibility reviews based upon governing policies.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
