As Lead Clinical Research Coordinator, Project Manager, 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.
Serve as the team leader for clinical research studies and the primary point of contact for the study team; manage a group of 8-12 staff members and study investigators; may serve as a direct supervisor for some members of the study team which includes the conduct of annual performance evaluations.
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; may orient and train study staff on applicable policies and procedures and study conduct.
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.
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,with 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: inclusion/exclusion criteria, informed consent process/documentation of consent; recruit/screen subjects for eligibility, gather info from medical record, field phys referrals, post ads/schedule visits, Collect/prepare/ship/store biological materials using universal precautions.
Conduct informed consent process and ensure that the subject understands what is required ; schedule/run study visits, which includes ensuring sufficient staff and physical resources are available to conduct the visit; conduct study visits, and obtain and document information within the time frame specified; write progress notes that reflect study procedures; may complete assessments on study subjects/patients per protocol; follow-up with items and patients/subjects as part of research study.
Monitor for outward effects or issues regarding patient/subject safety and report this to the Principal Investigator, Physician and/or Clinical Nurse; schedule, order (if appropriate), and follow-up on all tests, labs, procedures, exam, and treatment; ensure that adverse events are reported to regulatory and governing bodies in a timely manner.
Maintain complete/accurate subject charts, case report forms, enrollment logs, and hospital records from patient screening through final follow-up; record/update/edit/maintain confidential info in a neat/accurate/ timely manner and ensure subsequent data collection as reqd; secure signatures and forward documents/forms to appropriate destination; maintains files in an organized/up-to-date manner in order to facilitate their retrieval and maintains copies of all required documentation and forms.
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.
Other duties and responsibilities as assigned.
Internal Number: 43490
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Penn has a long and proud tradition of intellectual rigor and pursuit of innovative knowledge, begun by Benjamin Franklin in 1740. That tradition lives today through the creativity, entrepreneurship, and engagement of our faculty, students, and staff. Academic life at Penn is unparalleled, with an undergraduate student body of 10,000 from every U.S. state and around the world. The entering class of 2015 is the most talented and diverse in Penn's history. Consistently ranked among the top 10 universities in the country, Penn welcomes an additional 10,000 students to our top-ranked graduate and professional schools.