Clinical Research Coordinator B

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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.

Posted Job Title

Clinical Research Coordinator B

Job Profile Title

Clinical Research Coordinator B

Job Description Summary

This position will support the management of 5-6 clinical research studies (all phases) that involve assessment of new devices, diagnostic tests for lung cancer, and an investigational drug for pleural infection. Under the indirect supervision (minimal supervision) of the Principal Investigator (PI) and Project Manager (PM), the Clinical Research Coordinator B (CRC-B) will carry out research activities including recruitment, consenting participants, management of study materials, IRB submissions, device and supply management, biosample handling (collection, shipping and processing), and preliminary data analysis with manuscript writing. The CRC-B will work on industry sponsored research across three sites (HUP, PPMC, and PAH) that may include working with central IRB regulation and communicating frequently with sponsors, CROs, and coordinating site study teams. Participate in study team meetings and ongoing protocol training/compliance meetings. Show vigilance in patient safety, protocol compliance and data quality. Adhere to all University of Pennsylvania, FDA and GCP guidelines.

Job Description

Job Responsibilities

Planning and implementation of study protocols.

Manage regulatory aspects of clinical research studies (e.g IRB submissions, CTSRMC submissions, study binders).

Screening and enrollment of study participants.

Data collection, data entry (PennCTMS) and CRF completion.

Oversee device management and biosamples (collection, processing, inventory and shipment).

Overseeing internal audits.

Correspondence and team meetings with study sponsors, CROs and investigators.

Working with investigational drug services (IDS) for placebo controlled trials.

Conducting study visits.

Additional duties as assigned.

CONTINGENT UPON FUNDING

Qualifications

• Bachelor of Scienc