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Location: Worcester, MA
Business Unit: UMass Med School
Department: School - Diabetes - W710025
Job Type: Full-Time
Salary Grade: 45
Union Code: Non Union Position -W60- Non Unit Professional
Num. Openings: 1
Post Date: March 8, 2022
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
- Oversee all aspects of clinical trial program billing review, working with Hospital Billers and internal stakeholders to ensure accurate and appropriate subject billing and compliance with approved Trial Coverage Analysis
- Facilitate clinical trial implementation and ensure regulatory compliance for the conduct of clinical research at UMMS/UMMHC; demonstrate familiarity with research protocols, regulatory mandates, and staff education to ensure research regulatory compliance with federal and state regulations and institutional policies.
- Develop and supervise collaboration with participating research sites and external sponsors/stakeholders
- Design and assist in the production of self-instructional and multi-media programs that promote research goals
- 5-7 years experience developing, implementing, and evaluating health education/health promotion activities, managing/coordinating clinical trials or projects, or related experience
- 3 years experience in supervision of staff, project management of large scale research projects, and developing clinical trial budgets
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