RESEARCH PROJECT MANAGER
Duties: The Research Project Manager will be expected to understand the full complement of duties typically assigned to Clinical Research Coordinators at Penn and elsewhere and to execute these tasks as needed in service to the Department of Orthopaedic Surgery, specifically, the subspecialty of Fibrodysplasia Ossificans Progressiva (FOP). These duties include but are not limited to (1) managing a coordinated research team, (2) coordinating patient related activities and study progress with the clinical team caring for the subject, work with the clinical team to conduct assessments, collect medical history, monitor patient care, assess patient status and monitor treatment side effects, (3) recruiting of patients for research protocols, screening for eligibility, management of patient care, collection of medical and medication history, completion of patient visits according to protocol specifications, procurement of specific laboratory specimens, and completion of source documentation and clinical research forms, (4) reviewing all clinical and laboratory data with medical staff/PI and reviewing any protocol specific management of toxicities and adverse events, (5) leading the research team and sponsor organized meetings, (6) Regulatory responsibilities including writing, editing and submitting study documents such a protocols, summaries reporting of adverse events, informed consent to the IRB and other applicable committees (7) other duties as needed. Travel may be required. The Department of Orthopaedic Surgery FOP Division is actively engaged in collaborative studies with other institutions and with industry partners. The research project manager will be expected to be comfortably familiar with internal and external partners and to interact with them appropriately to advance the research goals of the Department, the Division, and collaborative partners.
Position is contingent on continued funding.
Qualifications: Bachelor's degree and 5 to 7 years of clinical research experience or an equivalent combination of education and experience. Prior experience in managing team required; experience with FOP patients is also highly preferred. This position requires professional and clinical skills and well-developed speaking, writing, and public relations abilities.
Experience limited to research on human data sets and/or bench lab only research will not satisfy. Experience with REDCap or similar electronic data collection systems preferred. A high level of proficiency with UPHS medical records system and research processes is an indispensable part of the job and should be present at the time of hire. The candidate should be energetic, interactive and comfortable working both independently and also as part of a team. Ongoing independent reading and discussion with faculty and other clinical practitioners, as appropriate to ongoing studies, evolving faculty interests and Departmental/Divisional needs. The position also requires working knowledge and understanding of the regulatory environment in which human subjects research occurs and conducting research operations accordingly. This includes but is not limited to ICH GCP, 21 CFR, 45 CFR 46, the HIPAA privacy rule, and similar. Excellent customer service inclination and problem solving skills are required.
The Research Project Manager must be extremely dependable, compassionate, able to meet deadlines, self-motivated, and highly efficient. She/he should be comfortable doing a variety of tasks, be able to balance multiple commitments, and be proficient at adaptive multi-tasking. She/he should demonstrate interest in the work, a strong work ethic, and personal and professional integrity. Penn CRC certification required or obtained within 3 months of employment; ACRP or SoCRA certification a plus. Must pass Pennsylvania's Child Protective Services Act (also known as Act 73) background checks within 30-90 days of employment
Reference Number: 40-25214
Salary Grade: 028
Employment Type: Exempt
Org: OS-Orthopaedic Surgery Research
Special Requirements: Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.
Job Family: I-Technical/Professional Research