Clinical Research Program Manager

Mass General BrighamBoston, MA
13dOnsite

About The Position

The Sean M. Healey & AMG Center for ALS at Mass General (Healey Center) is a busy and growing center for Amyotrophic Lateral Sclerosis that has a multidisciplinary ALS Clinic and is focused on research both clinical and observational. The team consists of physicians, nurse practitioners, nurses, physical therapists, speech and swallowing therapists, respiratory therapists, and research coordinators. We are in search of a Clinical Research Program Manager to help with research site operations, including managing research coordinators, participating in creating/revising SOPs, and participating in oversight/strategy of a maintaining and growing a high performing research site.

Requirements

  • 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, overseeing budget management, and subcontracting with associated institutions.
  • Ability to make independent effective decisions.
  • Strong organizational and communication Skills.
  • Ability to effectively supervise and train Staff.
  • Strong database management and computer skills.
  • Demonstrated analytical skills to problem solve effectively.
  • Must possess strong budget management skills.
  • Bachelor's Degree required

Nice To Haves

  • Master's Degree preferred

Responsibilities

  • 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.
  • Performs other duties as assigned
  • Complies with all policies and standards
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