Clinical Research Associate

UPMC•Pittsburgh, PA

6d•Onsite

About The Position

UPMC Department of Dermatology is seeking a full-time Clinical Research Associate to support its Clinical Research team at 3601 Fifth Avenue, 5th Floor, Falk Medical Building, Pittsburgh, PA 15213. The role coordinates and supports clinical research studies and is scheduled Monday through Friday from 8:00 a.m. to 4:00 p.m. The Clinical Research Associate facilitates patient entry and follow-up for clinical trials, supports informed consent and study implementation, coordinates study documentation and data collection, and assists with sponsor-related site activities. The position also works with patients, families, investigators, coordinators, research program leaders, radiologists, and other teams to support protocol compliance and trial progress.

Requirements

Bachelor of Arts degree in Business, Healthcare, or a related field, or an LPN license, and at least two years of clinical research experience; alternatively, a high school diploma or equivalent with current SOCRA or ACRP Clinical Research Associate certification and at least two years of clinical research experience.
Knowledge and ability to use Microsoft Office software and PC database applications.
Excellent organizational skills and ability to work on multiple projects or tasks simultaneously.
Motivation and ability to work with minimal supervision.
Ability to adapt to multiple organizational structures.
Ability to meet deadlines and respond flexibly to sudden workload changes.
Act 34 clearance.

Responsibilities

Create individualized study calendars and review them with patients.
Meet with the principal investigator and Clinical Research Coordinator/Supervisor as needed to review patient status.
Collect protocol data promptly and accurately.
Assist the coordinator with preparing, sending, and tracking documents for patient re-consenting.
Attend relevant seminars, conferences, sponsored educational events, and multidisciplinary meetings to support educational development.
Contact patients or family members after study completion to obtain follow-up or survival data, review survival record databases, and document follow-up in study CRFs and CTMA.
Provide consent forms to coordinators and investigators to support the informed consent process.
Meet monthly with the disease center research program leader and research team to present subject trial status.
Facilitate patient entry onto clinical trials.
Complete research requisitions to help prevent research procedures from being billed to third-party payers.
Perform consenting and implement studies for laboratory, registry, and non-therapeutic clinical trials.
Perform trial-related tasks, including processing, storing, and shipping specimens and administering study questionnaires.
Assist with entering subject trial registrations and study status updates into CTMA.
Obtain and review patient records, slides, radiology tests, laboratory results, and other materials before study entry.
Assist in verifying subject eligibility under study protocols by reviewing medical records, laboratory results, and radiology or CT scan results.
Complete financial review forms to determine insurance coverage for standard-of-care procedures and complete requisition forms.
Create study-specific source documents, case report forms, and study visit checklists.
Facilitate enrollment at community network sites and follow up on outstanding data collection.
Facilitate follow-up for protocol patients by developing maintenance-therapy data collection sheets.
Assist with coordinating sponsor-required initiation, site evaluation, monitoring visits, and audits.
Monitor subject compliance with oral study medications.
Assist in obtaining tumor measurements from radiologists or investigators to determine response information according to protocol.