Research - Laboratory/Non-Laboratory, Research Support - Laboratory/Non-Laboratory, Staff/Administrative
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Posted Job Title
Clinical Research Coordinator A
Job Profile Title
Clinical Research Coordinator A
Job Description Summary
Assists in clinical research tasks related to Cardiology. A variety of skills will be utilized, including: screening subject records for eligibility, recruitment of study subjects, data entry, database management, coordinating with study team members and other external department members, coordinating research studies, and processing samples. The candidate must be organized, detail oriented, accountable, and adaptable.
"This position is contingent upon available funding"
Screen daily to identify potential patients for specific studies and determine patient eligibility by communicating with physicians, clinical staff and by reviewing medical records to validate potential patient data against Inclusion /Exclusion checklists before introducing opportunity to patient. Recruit patients and explain protocol and consent forms. Assure original signed consents are maintained in study binder, Complete screening/enrollment logs and submit to sponsor, as protocol defines.
Assist in the conduct of clinical research studies performed by physicians using currently approved protocols, according to Good Clinical Practice. Obtain detailed knowledge of all components of study protocols by review of study protocol, related literature prior to study start date. Assure accurate and timely completion & updating of the Delegation of Duties and Authorized Signatures Form. Create & maintain research data, regulatory files, subject data, billing records, and study database.
Complete all source documents and worksheets within 48 hours of study activity. Complete and/or enter all clinical record forms (CRFs) within 5 working days or less depending on sponsor requirements. Create and maintain subject binders. Obtain records required to complete CRFs. Assure inclusion of enrollment information, research orders, and other communications are entered into the electronic medical record of each subject. Resolve data queries with sponsors/CROs in a timely manner.
Create and maintain a complete and accurate regulatory binder for each study. Assist with preparation and processing of all Institutional Review Board (IRB) documentation including submissions, continuing reviews, amendments and adverse event reporting. Prepare and process all regulatory documentation with research sponsors and clinical research organizations (CROs). Obtain the appropriate signatures for regulatory forms.
Schedule and conduct follow-up visits with patients and assure research team availability to assure all follow-up activities are conducted within sponsor designated timeframes including documentation of lost-to-follow-up efforts. Schedule additional protocol-required tests/procedures.
Monitor adherence to protocol throughout patient enrollment in study. Notify PI, RPM, sponsor of any deviations from protocol or adverse events. Assure reported trial data are accurate, complete, verifiable from source documents; collect data on adverse events and reports serious adverse events per regulatory standards.Â Assure correct version of approved consent is used for each enrollment. Assure timely notification to all enrolled subjects of significant changes in consent.
Other duties as assigned.
Qualifications Bachelor's Degree with 1-3 years of related experience in research and clinical study methodologies or equivalent combination of education and experience is required
Working Conditions Office, Library, Computer Room; Requires extensive safety
Physical Effort Typically sitting at a desk or table; Occasional lifting 25 lb. or less
Job Location - City, State
Department / School
Perelman School of Medicine
$36,401.00 - $65,521.00
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.
Internal Number: JR00007344
About University of Pennsylvania
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.