Tufts Medical Center
Boston, MA
Department::Clinical and Translational Science Institute (CTSI)
Schedule:Full-Time Regular
Shift:Day shift
Grade:12
Hours:8:30am-5:00pm; M-F; 40hrs/wk
Job Details:
Master's degree is required
Experience is required
This position reports directly to the Administrative Director of the Clinical and Translational Science Institute (CTSI) and is responsible for supporting the biomedical research enterprise and regulatory projects of the Tufts CTSI including 43 academic, hospital, industry, community and non-profit affiliates.
Under general direction of the Administrative Director, this position will (1) foster understanding of regulations and ethical issues inherent to biomedical research through education and consultation, (2) participate in innovative research projects that aim to better understand and/or demonstrate approaches that safeguard the well being of research subjects, and (3) work with offices responsible for improving systems and processes with the aim of enhancing clinical research (for example, patient recruitment; accelerate clinical trials; educate investigators on protocol development, federated IRB models, research subject advocacy, etc.).
Responsibilities:
Works with investigators and staff to ensure safe and ethical conduct of studies through education, and consultation.
Participate in the development of and implementation of policies and procedures to facilitate the protection of human subjects.
Coordinates linkages with other Tufts CTSI components.
Provides educational resources related to human subjects protections to the Tufts CTSI-wide research community, including affiliated hospitals.
Assists with efforts to streamline the Institutional Review Board (IRB) and clinical trial contracting process. Assists the CTSI Central Office with public education efforts focused on clinical research.
Performs other similar job related duties as required or directed (that may or may not be regulatory in nature).
Requirements:
Masters degree in a related field.
Appropriate training and experience within the human subjects/clinical research arena.
Thorough knowledge of federal, state, and local regulations governing clinical research and human subjects protection. Able to multi-task and communicate effectively.
At least 5 years in a project management position.
Familiarity with federal regulations and policies that protect subjects in clinical research.
Appropriate expertise in clinical research and human subjects protection.
High-level interpersonal skills (to interact collaboratively with faculty, administrators and staff from diverse backgrounds and levels).
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