Clinical Research Project Manager

Massachusetts General Hospital
United States, Massachusetts, Boston
149 13th Street (Show on map)
Feb 12, 2025
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. Does this position require Patient Care? No 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. 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 Licenses and Credentials 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 staff from other CONNECTS projects, e.g.: Regular meetings of CONNECTS working groups Annual CONNECTS network-wide meetings Coordinate activities related to the NIH-mandated Plan to Enhance Diverse Perspectives: Set up and monitor annual application process for trainees Assist with reviewing applications and assigning trainees to teams/programs Organize training camps and trainee project presentations Manage day-to-day operations of the investigative team, e.g.: Preparation of grant proposals, manuscripts, and presentations Maintenance of IRB or biosafety protocols and material transfer agreements Scheduling of scan sessions Packing and shipping of biological samples to collaborating sites Purchasing requests for equipment and supplies Assist with team supervision: Onboard new team members Supervise research assistants Assist with performance reviews and corrective action SKILLS & COMPETENCIES REQUIRED: A background relevant to neuroscience, as evidenced by relevant coursework. The ideal candidate will have a degree in neuroscience, biology, or related field, and an interest in learning about cutting-edge imaging tools. Strong quantitative skills. High comfort level with computers, and ability to acquire new computer skills. Ability to prioritize multiple tasks and handle fluctuating priorities and deadlines. Excellent organizational and decision-making skills. Excellent oral and written communication skills. Excellent interpersonal skills and ability to supervise others. Ability to work independently as well as within an integrated research team. A high degree of professionalism and attention to detail. SUPERVISORY RESPONSIBILITY: Supervise ~3 research assistants directly and ~7 other research staff indirectly. FISCAL RESPONSIBILITY: The individual will be responsible for ordering research equipment and supplies for the lab, monitoring and reviewing scanning and IT invoices, and reporting on usage of laboratory funds to the PI. Physical Requirements The position involves working in a computer lab and in imaging facilities with fixed post mortem brains. Flexibility to oversee data acquisition on evenings or weekends, depending on scheduling constraints of the respective imaging facilities, is required. The General Hospital Corporation is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.