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Purpose:

The Clinical Research Services (CRS) team is made up of nearly 200 staff members who facilitate the development, implementation, coordination, internal data monitoring, and completion of oncology-focused trials at Hillman. These trials include institutional (investigator-initiated), multi-center cooperative group/National Clinical Trial Network (NCTN), consortium, and industry-sponsored trials. Using a disease-specific centers model for conducting clinical trials, CRS provides study development and implementation assistance, submissions to the FDA, IRB processing, patient recruitment, study coordination, study-specific training, data collection, and specimen collection and processing.

UPMC Hillman Cancer Center is currently hiring a regular full-time Laboratory Clinical Research Associate I to help support the Clinical Research Services team located within the Hillman Cancer Center in Shadyside/Pittsburgh, PA, and at our Women's Oncology Program at Magee Women's Hospital location in Oakland/Pittsburgh, PA. This position will work a Monday through Friday daylight schedule working between locations.

Under the direction of the Clinical Research Manager, the research associate will work with physicians, nurses, and allied health professionals to facilitate clinical research trials provided through the University of Pittsburgh Cancer Institute (UPCI) and UPMC Cancer Centers and to independently execute job functions related to protocol management.

Responsibilities:

+ Clinical trial research lab responsibilities

+ Responsible for de-identification of samples, consenting of patients, extraction of samples, and coordination with the clinic at UPMC Hillman Shadyside and UPMC Community Centers.

+ Responsible for prompt and accurate data entry for protocols.

+ Assists with monitoring visits and coordinate data collection including data locks.

+ Processes study specific data collection documents into case report forms.

+ Assists the CRC in screening process and ensures that patient's records, archival tissue, radiology tests, lab work results, etc. are obtained prior to patient entry into a study.

+ Responsible for lab kit preparation.

+ Demonstrates industry-accepted good documentation and clinical practices during the conduct of research to collect quality data, in compliance with institutional, and statutory guidelines.

+ Maintains patient tracking spreadsheets to ensure data entry requirements are met.

+ Works with CRC in managing the visits of active and FU patients on research protocols.

+ Performs query resolution.

+ Assists in the coordination of initiation, site evaluation, monitoring visits, and audits required by the sponsor.

+ High school diploma or equivalent required.

+ Bachelor's degree in healthcare or related field

+ OR four (4) years of experience in clinical research and/or related setting

+ OR three (3) years of experience in clinical research with certification.

+ A minimum 1-year post-college lab experience is strongly preferred

+ Pathology, genetics, or histology lab experience is a plus.

+ Additional skills include prior knowledge and use of Microsoft Office software products and the ability to work with PC database applications.

+ Preferred knowledge of research methodology and prior supervisory and or/ project management experience preferred.

+ Oncology and/or Research experience preferredLicensure, Certifications, and Clearances:

+ Act 34

UPMC is an Equal Opportunity Employer/Disability/Veteran