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Posted Job TitleClinical Research Coordinator C (Department of Cardiovascular Medicine)Job Profile TitleClinical Research Coordinator CJob Description SummaryThis position will be a resource for best practices of managing major clinical trials. The coordinator will provide guidance to both study trials and device trials. The incumbent will be a liaison to departmental interaction such as the investigational team, the nursing units and sponsor. They will be a resource to other members of the team and will oversee the implementation of new clinical trials. Will review all new trials to help identify the challenges and opportunities discovered. Will problem-solve the challenges to implement a plan of action. Work with the regulatory manager to ensure that submissions to the IRB are completed in a timely manner.Job Description
This position is contingent upon favorable funding.
The Division of Cardiology at Pennsylvania Hospital seeks a full-time Clinical Research Coordinator to organize, coordinate and implement complex studies involving a wide variety of investigational products/devices and various sponsors. S/he will be responsible for all aspects of clinical trial coordination. The coordinator will assist physicians/investigators with initiating study procedures for new industry-sponsored and investigator-initiated clinical trials. Sh/e will organize and assist in the preparation of documents and systems needed for initiation, enrollment, monitoring, internal and external auditing, and study close-out visits for complex Phase I-IV clinical trials. They will interface with regulatory authorities, sponsors, CROs, and cooperative groups as directed by the supervisor.
He/she will be responsible for submission of studies to Institutional Review Board (IRB), ongoing maintenance of regulatory documentation including additional applicable reviewing entities per each entity’s required timeline, and maintenance of the essential documents binder/TMF. S/her will assist in review of new trials, assist with development of site specific documents (CRFs, SOPs, databases development), help investigators identify the challenges and opportunities, problem-solve the challenges and implement a plan of action to mitigate potential barriers.
He/she will also be responsible for the screening of patients, provision and discussion of informed consent documents, subject enrollment, collection and storage of biological samples and related study documents, implementation and performance of study related procedures and assessments, collection of clinical and research data with proper source documentation and CRF completion, perform accurate data entry to study specified databases, and conduct accountability of investigational product and devices. The coordinator will execute and ensure adherence to the protocol and Good Clinical Practice, while taking an active role in preparation of trial audits and inspection. S/he will provide regular updates to the investigators, research team and other stakeholders as needed. S/he may 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. S/he may act as a mentor to coordinators who have joined the unit with less research experience.
Job Responsibilities
Qualifications
Position is contingent upon funding
Job Location – City, StatePhiladelphia, PennsylvaniaDepartment / SchoolPerelman School of MedicinePay Range$51,824.00 – $70,000.00 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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