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Posted Job TitleClinical Research Coordinator C (Department of Dermatology)Job Profile TitleClinical Research Coordinator CJob Description SummaryThe Clinical Studies Unit, Department of Dermatology of the seeks a full-time Clinical Trials Coordinator to organize, coordinate and implement studies involving a wide variety of investigational products and various sponsors. He/she will be responsible for all aspects of clinical trial coordination including: subject recruitment, detailed data entry, subject visits and follow-up and regulatory documentation.Responsibilities
Participate in the development/maintenance of study specific case report forms and source document tools. May include the development and management of REDCAP web sites for internet data capture. Organize and maintain all documentation required by the sponsor or CRO per GCP - includes source documentation, case report forms, and research charts.
Collect, review and report timely, valid, accurate study data. Obtain records required to complete case report forms. Update/maintain study record in the Clinical Trials Management System (CTMS) in real-time. 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. Responsible for IND reporting and/or assisting Sponsor with annual IND reporting.
Participate in Sponsor meetings/teleconferences as indicated. Ensure that site is meeting project timelines. May act as a mentor to coordinators who have joined the unit with less experience.
Duties
This individual will work under general supervision. They will assist with initiating study procedures. Coordinate the conduct of multiple trials. Actively involved in subject recruitment and screening. Oversee subject visits. Complete data entry in a timely manner. Adhere to all University of Pennsylvania, FDA and GCP guidelines.
This individual will work independently with minimal supervision. May act in a lead capacity or as back-up to manager.
Work directly with physicians to design, set-up and execute studies. Be responsible for writing investigator initiated / clinical trials in collaboration with faculty investigator. Speak at site initiation visits for IITs where physician is the Principal Investigator. Assist in analyzing clinical data to determine response and clinical outcomes; assist with literature reviews; contribute to the preparation of study abstracts, posters, manuscripts and grant applications.
Participate in budget preparation for trials as needed. Independently move a clinical trial through each phase of development, resolving issues and queries with input from a supervisor as required
Independently manage complex (i.e. multi-drug regimens, high toxicity potential, multiple random assignments, or immunotherapies, etc.) Phase I - IV clinical trials and registries within the Clinical Studies Unit. This includes managing various aspects of multi-center trials such as working with partnering institutions on budgets and IRB documentation, and monitoring external research site if indicated.
Develop, schedule and oversee subject visits and any necessary testing and appointment coverage according to protocol and in accordance with Good Clinical Practice ("GCP") (e.g. scheduling subject visits within the appropriate window, ensuring all tests and assessments at each visit are performed, reporting adverse events and ensuring review and appropriate follow-up by investigator, coordinating treatment administration and/or procedures with physician, monitoring patient care and treatment side effects in concert with investigators, detailed documentation of study activities).
Act in lead capacity in coordination of unit projects and assist unit managers in overseeing execution of project timelines as well as completion of study related activities delegated to research coordinators/assistants who provide study related support (e.g., regulatory submissions and data entry). May be responsible for orientation/mentoring of new staff and act as resource to current staff members with study related issues. Act as back-up to the manager when required.
Qualifications
The successful candidate must have: (1) practical experience coordinating the day-to-day activities of multiple therapeutic research protocols; (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 dermatology preferred but not required; (6) ability to work flexible hours; (7) possess working knowledge of the Title 21 Code of Federal Regulations (CFR), International Conference of Harmonisation (ICH) and Good Clinical (Research) Practice (GCP) Guidelines. Oncology clinical trials experience preferred.
COVID-19 vaccination is a requirement for all positions at the University of Pennsylvania.
This position is contingent upon funding
Job Location - City, StatePhiladelphia, PennsylvaniaDepartment / SchoolPerelman School of MedicinePay Range$51,824.00 - $67,000.00 Annual RateSalary offers are made based on the candidate's qualifications, experience, skills, and education as they directly relate to the requirements of the position, as well as internal and market factors and grade profile. Affirmative Action Statement
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