Under the general direction of the Principal Investigator or designee, the Research Project Manager is responsible for implementing multiple research and other projects from inception to completion and overseeing the daily operations.
Manage the performance and activities of research support staff
Responsible for operational procedures for one or more research teams
Represent studies/projects in internal and external settings
Coordinate the recruitment, hiring and training of staff
Participate in Steering Committee meetings and other study related activities
Manage all study events/tasks including offsite locations
Present study status reports
Design and implement research project tracking systems
Oversee all regulatory documentation, including local or central IRB. Oversee provision of data/support to study Investigators, sponsors and/or external monitors/auditors
Monitor strict adherence to all study protocols, including all regulatory requirements adhering to appropriate federal, local and institutional guidelines. Identify and resolve issues with protocol compliance. Keep principal investigator and manager aware of any issues regarding compliance
Comply with all safety and infection control standards appropriate to this position
Adhere to Good Clinical Practice (GCP) guidelines and all human subject protection practices
Collaborate with investigators in grant preparation, evaluation of protocol feasibility, conference presentations, manuscript writing and other project reports
Provide detailed written summaries from literature searches and related sources to serve as a resource for the study team and clinicians/PI's
Assist in the development of the design, development, and documentation of study related data and collection tools, (e.g. questionnaires, treatment data and/or therapeutic checklists) , IRB submissions and protocol implementation activities.
Document and collect data for research related procedures performed during participant study visits. Ensure clinicians and/or PI accurately document their study activities according to protocol.
Oversee the input of study related information in the data management system within the required timeframe
Conduct preliminary quality assurance reviews of study data.
Ensure consent of research participants is obtained in accordance with the IRB approved protocols and all applicable regulations including HIPAA are fulfilled.
Manage the recruitment, screening, and subject selection activities for a research study
Monitor adherence to protocol required study procedures and schedule
Perform other duties as required.
Bachelor's degree in a scientific or health related field, or equivalent experience
5-7 years of relevant experience with a minimum of 1 year of supervisory experience
Demonstrated knowledge of quality management principles in a scientific or hospital setting
Ability to travel off site locations
University Of Massachusetts Medical School