Clinical Research Coordinator
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Job Description Summary
The purpose is to implement the Improving Access to Cancer Clinical Trials (iMPACT) study at the Abramson Cancer Center. The iMPACT study is a phase II/III multi-site study examining the impact of Lazarex Foundation’s Financial Reimbursement Program (FRP) among patients enrolling in Therapeutic Cancer Clinical Trials (TCT) at the Abramson Cancer Center (ACC). The Clinical Research Coordinator (CRC) is will oversee the start-to-end processes from study start-up to ongoing data collection and study management to data analysis and presentation. The individual will assume the lead role to ensure implementation of and adherence to protocol.
POSITION IS CONTINGENT UPON FUNDING
The Clinical Research Coordinator (CRC) will oversee the start-to-end processes from study start-up to ongoing data collection and study management to data analysis and presentation. The individual will assume the lead role to ensure implementation of and adherence to protocol. Specifically, the responsibilities of the iMPACT Study CRC will include:
Complete all required human subjects, data management, and institutional required training prior to launching this study. Obtain IRB and CTRMC approvals. Screen and identify patients with cancer who are eligible for cancer clinical trials at the Abramson Cancer Center (PCAM, HUP and PAH) AND who are also eligible for the iMPACT trial. Educate physicians and patients about the study; Recruit, consent and enroll patients, including helping participants overcome barriers to participating the iMPACT trial. Schedule study appointments and calls for the required information. Administer study instruments including questionnaires and interviews. Coordinates translation, if needed. Collect, review and report timely, valid, accurate study data (Redcap) and conduct data queries. Participate in the development/maintenance of study specific case report forms and source document tools. Monitor patients per protocol requirements and ensure adherence to protocol requirements, organize and maintain all documentation required by the sponsor or CRO- includes source documentation, case report forms, and research charts. Obtain records required to complete case report forms. Update/maintain study record in the Clinical Trials Management System (CTMS aka Velos) in real-time including study status, screening logs, serious adverse events and subject enrollment status. Maintain clinical trial databases by completing case report forms within 5 business days of subject visits and resolving data queries within 5-7 days of issuance. These timelines may be shortened during periods of data lock or in preparation for abstract/manuscript submission. Manage the study budget and prepare study budget reports. Works with Operations, Regulatory, Education/QA. Acts as the initial clinical resource and liaison between physicians, nurses, and laboratory personnel. Participate in weekly or bi-weekly meetings with PI and Sponsor and disease team meetings to review the study status. Prepare agendas and record minutes for circulation. Present regular updates to the research team and sponsor. May supervise collaborating students, trainees and community leaders. Work with community partners to organizing and help lead educational and outreach events in the community to promote the iMPACT trial multiple times per year. Adhere to the requirements of the University of Pennsylvania, GCP, FDA and all applicable regulatory bodies.
The successful candidate must have: (1) A Bachelor’s degree and at least 2-4 years of related experience coordinating day to day activities of clinical research projects or an equivalent combination of education and experience required. (2) practical experience coordinating the day-to-day activities of multiple research projects; (2) effective verbal and written communication skills; (3) ability to learn new methods quickly and multi-task; (4) demonstrated ability to work as part of a team as well as independently; (5) knowledge or experience in oncology preferred but not required; (6) ability to work flexible hours; (7) possess working knowledge of the IRB and human research protection regulations and Title 21 Code of Federal Regulations (CFR), International Conference of Harmonization (ICH) and Good Clinical (Research) Practice (GCP) Guidelines
Job Location - City, State
Department / School
Perelman School of Medicine
$42,953.00 - $77,315.00
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