Clinical Research Coordinator B (Dept. of Orthopaedic Surgery Research)
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Posted Job Title
Clinical Research Coordinator B (Dept. of Orthopaedic Surgery Research)
Job Profile Title
Clinical Research Coordinator B
Job Description Summary
This position will support the faculty, residents, and fellows of the Department of Orthopaedic Surgery in the preparation for, conduct of, and completion of any and all Human Subjects Research projects and sub-projects in which they are engaged. This position will report administratively to the Manager of Clinical Research for Orthopaedic Surgery and will report, on a study-specific basis to the respective principal investigators. The CRC B for the Department of Orthopaedic Surgery will also work on Department level research, education, and quality/process improvement initiatives as required. Position contingent upon funding.
DUTIES: The CRC 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. 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 is actively engaged in collaborative studies with other institutions and with industry partners. The CRC B 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 and collaborative partners. Must be willing to travel between clinical sites.
Bachelor's degree in Biology or similar science preferred and 2-3 years of experience or an equivalent combination of education and experience 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. Position contingent upon funding.
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.
Job Location - City, State
Department / School
Perelman School of Medicine
$42,953.00 - $77,315.00
Affirmative Action Statement
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Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.