University of Pennsylvania Clinical Research Coordinator B in Philadelphia, Pennsylvania
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Posted Job Title
Clinical Research Coordinator B
Job Profile Title
Clinical Research Coordinator B
Job Description Summary
This position coordinates immune therapy clinical trials sponsored by the Center for Cellular Immunotherapies or industry sponsors and conducted by the Clinical Trials Unit at the University of Pennsylvania.
Coordination of trial activities will include but is not limited to obtaining informed consent, screening and enrollment of study participants, scheduling study related visits (e.g., lab tests and procedures), processing and shipping of study related specimens, scheduling of administration of investigational or study specified medications (e.g., study vaccines), completion of source documents and case report forms (CRFs), preparation for monitoring visits and audits, assisting with the submission of study documents to all applicable institutional committees (e.g., IRB) for initial approval, continuing reviews and for approval of any amendments. Communicate with sponsor entities to ensures compliance with project management timelines and milestones. Due to the complex nature of our clinical trials we are seeking candidates with excellent communication skills, attention to detail, organizational and time management skills, and the ability to work independently and as a team member. This position is contingent upon funding.
Possess working knowledge of the ICH-GCP regulations and an understanding of clinical trial processes, and the conduct of clinical studies.
Possess appropriate computer skills and working knowledge of Microsoft Office tools (e.g., Word, Excel, PowerPoint).
Ensure proper screening and enrollment of all study participants, including administering informed consent and confirming subject study eligibility prior to participation
Ensure proper reporting of serious and non-serious adverse events to the Sponsor and all applicable institutional or study related committees and personnel (e.g., IRB, DSMC, DSMB/Medical Monitor) according to applicable regulations and policies
Coordinate the administration of the investigational product and study related medications including obtaining orders, scheduling administration dates, administration of investigational and study related medications (as applicable), monitoring subjects for post-administration adverse events or reactions
Manage scheduling and coordination of subject study specified treatment, follow-up visits and procedures
Meet with Principal Investigator routinely to discuss study related issues and to ensure completion of study related procedures (e.g., determination of causality for adverse events, deviation/exception requests)
Manage collection of data from source documents pertaining to study visits and transcribe to case report form, including concomitant medications and adverse events
Prepare and maintain study related documents/patient charts for audit and monitoring review. Communicate with study monitors and auditors to schedule visits and resolve queries.
Assist with protocol development to ensure logistical feasibility of all study related procedures and study work-flow
Assist with mentoring and training of new staff
Other duties and responsibilities as assigned
QualificationsBachelor's Degree with 2-4 years of related experience in research and clinical study methodologies or an equivalent combination of education and experience requiredWorking ConditionsOffice, Library, Computer RoomPhysical EffortTypically sitting at a desk or table; Intermittently sitting/standing/stooping; Occasional lifting 25 lb. or less
Job Location - City, State
Department / School
Perelman School of Medicine
$42,953.00 - $77,315.00
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.
The University of Pennsylvania's special character is reflected in the diversity of the Penn community. We seek talented faculty and staff who will constitute a vibrant community that draws on the strength that comes with a substantive institutional commitment to diversity along dimensions of race, ethnicity, gender, sexual orientation, age, religion, disability, veteran status, interests, perspectives, and socioeconomic status. Grounded in equal opportunity, nondiscrimination, and affirmative action, Penn's robust commitment to diversity is fundamental to the University's mission of advancing knowledge, educating leaders for all sectors of society, and public service. The University of Pennsylvania prohibits unlawful discrimination based on 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.
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