As Translational Clinical Research Coordinator, work as part of a team to initiate and manage research studies in the most optimal fashion. Ensure the accurate execution of research protocols in accordance with Good Clinical Practices, HIPPA, and other federal/institutional requirements, and meet required obligations to patient/subject, Principal Investigator, research team and the sponsor. Directly interface with patients/subjects, the Principal Investigator, and study team in support of the clinical trials.
Assist the Lead CRC to plan, organize, and run study-related meetings, including but not limited to site initiation visits, weekly staff meetings, monitoring visits, and training sessions; maintain complete and accurate records of all meetings and training sessions, and ensure that resulting action items are completed in a timely manner.
Demonstrate knowledge of and follow all policies and procedures of the host institution where the study is being conducted, applicable state and federal regulatory requirements, ICHGCP, Institutional Review Board (IRB) policies, HIPPA, and other requirements as appropriate; demonstrate a thorough knowledge of the research study, study rationale, study subject, and clinical procedures associated with each study to which he/she is assigned.
Assist the Lead CRC to prepare and submit applications to the IRB, respond to IRB queries or concerns, and remain aware of the regulatory statuses for assigned protocols; maintain complete, accurate, and well-organized study essential documents; may be asked to draft or edit study protocols and associated documents, such as informed consent forms, manuals of procedure, advertisements, and participant brochures.
Responsible, in conjunction with the study team, for developing/implementing recruitment strategies, assessing effectiveness of recruitment efforts, and reporting on recruitment/retention status to PI; review screening process with PI such as inclusion/exclusion criteria, informed consent process, and documentation of consent; recruit/screen potential patients/subjects for eligibility, medical record review, physician referrals, posting advertisements, and scheduling patient evaluation visits.
Conduct informed consent process, ensure patient/subject fully understands req.; schedule/run visits, ensure sufficient staff/physical resources are available; timely documentation of progress notes; complete assessments on subjects; follow-up on items/subjects. Monitor effects/issues regarding subject safety and report to Pl/provider/Clinical Nurse; schedule/order/follow-up on tests/labs/procedures/exam/treatment; ensure adverse events are reported to regulatory/governing bodies timely.
Maintain complete/accurate subject charts/case report forms/enrollment logs/hospital records from patient screening through final follow-up; record/update/edit/maintain confidential information in a neat/accurate/timely manner and ensure subsequent data collection as required; secure signatures and forward documents/forms to appropriate destination; maintains files in an organized and up-to-date manner in order to facilitate their retrieval and maintains copies of all required documentation and
Interact with patients/subjects and families in a courteous and professional manner; show consistency and regular follow through with his/her patients/subjects; respond to requests in a timely manner, give complete and accurate information, and encourage required dialogue and follow- through; utilize available resources and established procedures to identify problems ideally before they happen, suggest solutions, and implement corrective action for quick resolution.
May serve as the back-up to the Lead CRC in his/her absence, which includes management of the study team and serving as the point of contact for day-to-day study issues; may be required to assist in the set-up and break-down of the clinic area before and after study visits. Collect, prepare, ship, and/or store biological materials using universal precautions.
Assist Lead CRC with QC/QA processes related to the study; implement study QA and QM plans; review study records, including study charts/case report forms/informed consent forms/essential documents, for accuracy/completeness; identify and seek appropriate correction of errors/omissions within study records; draft reports of QA activities and provide to appropriate parties; assist in the development/implementation of corrective action plans as necessary.
Other duties and responsibilities as assigned.
Internal Number: 43489
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