MGR RES PROJECT A
Duties: Research Project Manager A will be responsible for supporting clinical trials within Nuclear medicine and Molecular Imaging division of the department of Radiology including the initial set-up, regulatory filings, implementation and oversight of new and ongoing trials. Responsibilities will include regulatory submissions, operationalizing study protocols and procedures, correspondence with sponsors and/or investigators regarding start up and study management, communication with internal UPenn regulatory bodies and external regulatory agencies (e.g. FDA, sponsor or CROs). This position will include a supervisory role in training for clinical research coordinators or research assistants within the Nuclear Medicine clinical coordination unit. Tasks will include working closely with PET Center Administrative director, Principle Investigators and other coordinators in the unit and in collaborating departments and staff within the nuclear medicine clinic to plan and implement study procedures, collect and monitor data and report study progress internally and to study sponsor. Responsible for preparation and submission of IRB and other regulatory submissions, correspondence and organization and maintenance of regulatory documentation following good clinical practice guidelines for conduct of research involving human subjects. This position will oversee or perform data entry, aid in resolving data queries, review screening and enrollment for multiple studies and work with other study team members to identify optimal recruitment strategies. Project manager will oversee scheduling of study related visits, participate in preparation and conduct of monitoring and audits including study initiation and closeout visits with sponsor.
Qualifications: A Bachelor's degree and 3-5 years of experience in human subjects research, or an equivalent combination of education and experience, are required. Effective communication and writing skills, effective problem solving skills, working knowledge of regulatory documents and regulatory review requirements, understanding of humans subjects research protection regulations and training in good clinical practices required. Ability to multi-task, work independently and work as part of a team. Ability to train and supervise other staff to conduct human subjects research. Experience working with electronic data systems.
Reference Number: 40-28038
Salary Grade: 027
Employment Type: Exempt
Job Family: I-Technical/Professional Research