Clinical Research Project Manager
Mass General BrighamAbout the role
Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham.
Job Summary
Summary: Responsible for the management of multiple clinical research studies and the direct hiring and supervision of Clinical Research Coordinators. Serves as the key liaison with the sponsor, IRB, core laboratories, site P.I.'s, as well as all levels of study staff. Will also coordinate trial initiation, patient recruitment, and expedite project approval and study start-up time. Responsibilities also include participation in developing and maintaining standard operating procedures for the projects, developing advertising strategies to support recruitment activities, oversee budget management and subcontracts with associated institutions.Essential Functions: Supervises operations of all study staff.
-Writes operations manuals.
-Participates in the formulation of policies and procedures for the study.
-Prepares Case Report Forms.
-Coordinates multi-center trials with NIH, FDA and Private foundations.
-Reports study progress at investigators' meetings.
Qualifications
Education
Bachelor's Degree Related Field of Study required or Master's Degree Related Field of Study preferred
Can this role accept experience in lieu of a degree?
No
Experience
Required: Research Related Experience 5-7 years required, and Supervisory Experience 1-2 years preferred
Preferred: Experience in quality assurance and analysis of biomedical data and coding experience.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- Ensure the timely and successful completion of annual project milestones:
- Communicate milestones to the investigative teams responsible for them
- Facilitate communication between teams as needed to achieve milestones
- Monitor progress and propose actions to overcome obstacles
- Communicate progress and issues to the PI
- Manage data flow
- Interface with research staff across sites to ensure timely exchange of data
- Perform regular reviews of remote and local databases to identify redundancies and improve organization
- Assist with data quality assurance
- Manage documentation and training materials for team members
- Work with team members to compile documentation for common data acquisition and analysis pipelines
- Ensure that documentation remains up to date
- Serve as a point person for interfacing with NIH:
- Compile annual milestone reports
- Communicate with NIH program staff regarding progress or changes to milestones
- Organize in-person or hybrid meetings and events of the investigative team, e.g.:
- Regular meetings of local team at MGH
- Regular meetings with teams across sites
- Biannual coding retreats
- Annual site visits by NIH program staff and external advisory board
- Assist with organizing CONNECTS network-wide activities, in coordination with
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