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Posted Job TitleClinical Research Coordinator, Clinical Studies, Department of DermatologyJob Profile TitleClinical Research Coordinator BJob 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.Job Description
Responsibilities
– Coordinate the conduct of 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. Complete relevant training to function in the role including but not limited to electronic databases, and processing/shipping specimens. Maintain Delegation of Authority Logs. Coordinate completion and appropriate documentation of study staff training.
– Assist manager with initiating study procedures for new industry-sponsored and investigator-initiated clinical trials. Organize, participate and assist in the preparation of documents needed for initiation, monitoring, internal and external auditing, and study close-out visits. Interface with regulatory authorities, sponsors and cooperative groups as directed by the manager.
-Be actively involved in planning and implementation of patient recruitment into studies (involves deciding which strategies are best, reviewing medical records of upcoming new and return patient clinic visits and discussing with investigators, reaching out to potential referring physicians, approaching potential subjects in the office or speaking to them by phone, asking pre-screening eligibility questions, etc.).
– 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, monitoring patient care and treatment side effects in concert with investigators, detailed documentation of study activities). Ensure drug accountability and appropriate diary completion. Ensure adequate drug supply and assist Pharmacist with ordering if needed. Monitor subjects per protocol requirements and ensure adherence to protocol. Show vigilance in patient safety, protocol compliance and data quality. Adhere to all University of Pennsylvania, FDA and GCP guidelines.
– 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.
– Perform additional duties as assigned.
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.
Qualifications
Bachelor’s degree and 2-3 years of experience, or equivalent combination of education and experience, are required. The successful candidate must have: (1) 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 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.
COVID-19 vaccination is a requirement for all positions at the University of Pennsylvania.
Working Conditions Office, Library, Computer Room; Requires extensive safety
Physical Effort Typically sitting at a desk or table
This position is contingent upon funding.
Job Location – City, StatePhiladelphia, PennsylvaniaDepartment / SchoolPerelman School of MedicinePay Range$43,919.00 – $55,000.00 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
Penn adheres to a policy that prohibits discrimination on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.Special Requirements
Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.University Benefits
To learn more, please visit: https://www.hr.upenn.edu/PennHR/benefits-pay
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