CLINICAL RESEARCH COORD A/B

Duties: 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 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.
* Assist with Penn Vasculitis Lab operations including the specimen tracking database, receiving and shipping of specimens, and other tasks as needed.
* 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.

The Clinical Research Coordinator B is expected to perform the duties above with general 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. 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.

Qualifications: CLINICAL RESEARCH COORDINATOR A: Bachelor's degree and 1 to 3 years clinical trial/clinical research experience or equivalent combination of education and experience required.
CLINICAL RESEARCH COORDINATOR B: Bachelor's degree and 2 to 4 years of 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.

Reference Number: 40-28630

Salary Grade: 025/026

Employment Type: Exempt

Org: DM-Rheumatology

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.

Job Family: I-Technical/Professional Research

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