CLINICAL RESEARCH COORD B
Duties: The Clinical Research Coordinator B 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) writing, editing, and submitting study documents such as protocols, summaries, Informed Consent Forms (ICFs) and similar documents for faculty initiated studies, and submitting to the IRB and applicable committees according to the requirements of each reviewing body, (2) developing appropriate de novo study specific documents and study tools to enable the proper and compliant execution of investigator initiated studies including but not limited to Case Report Forms and completion guidelines, operations manuals, data management plans, standard operational procedures, workflow processes and similar (3) performing all site-specific activities associated with either faculty initiated or extramurally funded studies to ensure study and site compliance with applicable regulations and policies, whether Penn is or is not the lead study site (4) Ensuring study progress and patient safety by actively engaging the faculty through the clinic and other mechanisms to identify and enroll applicable subjects and performing all necessary activities associated with study maintenance including venipuncture, and specimen processing, and any and all protocol related functions, (5) becoming an integral part of the overall Human Subjects Research Program at the Division and Departmental levels, (6) train and oversee other staff, residents, or students as applicable in the conduct of human subjects research as needed, (7) taking initiative to observe and continuously satisfy patient needs and improve team knowledge, compliance, practices and processes applicable to human subjects research and (8) 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 Clinical Research Coordinator 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, preferably in Biology or similar science, and 2-4 years of experience with FOP patients or patients with rare debilitating diseases (clinical research), or equivalent combination of education and experience, is required. This position requires entry to mid-level professional 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 or developed immediately thereafter. The candidate should be energetic, interactive and comfortable working both independently and also as part of a team. Knowledge in the clinical practice of Orthopaedic Surgery is not expected at the time of hire but should be aggressively acquired through clinical exposure with faculty, attendance at Department and Division level conferences, and 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 CRC 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. Must also demonstrate extreme sensitivity to the needs and comfort of children, patients and families involved in clinical trials. Penn CRC certification required and/or ACRP or SoCRA certification a plus. Position contingent upon funding.
Reference Number: 40-26101
Salary Grade: 026
Employment Type: Exempt
Org: OS-Orthopaedic Surgery Research
Job Family: I-Technical/Professional Research