Clinical Research Coordinator

Pennsylvania United States
12 Oct 2018
End of advertisement period
12 Dec 2018
Contract Type
Full Time

The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn’s distinctive interdisciplinary approach to scholarship and learning.

Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play.

The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more.

The Perelman School of Medicine at the University of Pennsylvania is the oldest and one of the finest medical schools in the United States. Penn is rich in tradition and heritage and at the same time consistently at the forefront of new developments and innovations in medical education and research. Since its founding in 1765 the School has been a strong presence in the community and prides itself on educating the leaders of tomorrow in patient care, biomedical research, and medical education.

We are looking for a highly motivated, dedicated and detail-oriented individual to coordinate patient-oriented clinical and translational research projects within the Division of Rheumatology.

The primary duties of the Clinical Research Coordinator A (CRC-A) include, but are not limited to:

  • Daily coordination of multiple sponsored longitudinal studies and investigator-initiated research. Recruit, screen, & enroll potential study patients as specified per protocol. Schedule patient visits & any necessary testing/specimen collection.
  • Process & ship blood, urine, tissue & serum specimens.
  • Coordinate, organize and track acquisition of tissue samples and copies of radiographs from other academic medical institutions.
  • Prepare and process Institutional Review Board (IRB) documentation including submissions, continuing reviews, amendments, and adverse event reporting.
  • Coordinate, organize, complete, and maintain all documentation required by sponsor or clinical research organizations (CROs) including source documentation, case report forms, essential study documents, regulatory documents, and patient binders. Enter data in electronic data capture systems.
  • Work with research sponsors, CROs, or regulatory agencies on study initiation, monitoring, closeout visits, and any audits.
  • Show vigilance in patient safety, protocol compliance and data quality. Adhere to all University of Pennsylvania, FDA and GCP guidelines.
  • In addition to the duties outlined for CRC-A , the Clinical Research Coordinator B (CRC-B) is expected to perform the duties above with minimal supervision with the additional expectation that the candidate will develop novel solutions to research questions, and present and implement strategies to improve subject recruitment. (S)he will also assist with preliminary budget proposals and complete perspective reimbursement analyses. The CRC-B will streamline and improve current processes for requesting samples, organizing and tracking requests, returning tissue blocks, and closing out a request.
  • Position contingent upon funding.

CLINICAL RESEARCH COORDINATOR A: Bachelor’s degree and 1 to 3 years clinical trial/clinical research experience or an equivalent combination of education and experience required.

CLINICAL RESEARCH COORDINATOR B: Bachelor’s Degree and 2 years to 4 years of clinical trial/clinical research experience or an equivalent combination of education and experience required.

Both levels: Effective problem solving abilities; detail-oriented; effective communication and writing skills; strong organizational and time management skills; flexible and able to multi-task; demonstrated ability to work as part of a team, as well as independently; knowledge of IRB and human research protection regulations. Proficient in Microsoft Windows including Microsoft Excel and in using the internet as well as databases such as REDCAP and LabVantage. Prior clinical trial experience is required.

The ideal candidate has the duty to understand the role of the CRC as the intersection of study execution, customer service, subject safety, and overall compliance in clinical research. To this end, the proper candidate will be expected to have a strong foundation in clinical research regulations and operations through direct experience in the role.

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.