Mar 11, 2017
Administrative Jobs
Academic Affairs
Institution Type
Four-Year Institution

Duties: We are looking for a highly motivated, dedicated, organized, and enthusiastic individual who will provide study coordination, support, and training for investigator-initiated studies, multi-center research studies, and patient-oriented clinical and translational research projects within the Renal, Electrolyte, and Hypertension Division.

Position is contingent on continued funding.

* Prepare and process Institutional Review Board (IRB) documentation including submissions, continuing reviews, amendments, and adverse event reporting.
* Prepare, process, and organize all regulatory documentation.
* Coordinate, organize and maintain all documentation required by sponsor or clinical research organizations (CROs) - source documentation, case report forms, study and regulatory binders, and patient binders.
* Review and update research billing.
* Resolve regulatory-related queries with IRB, study sponsors and CROs.
* Work with research sponsors, CROs, or regulatory agencies on study initiation, monitoring, closeout visits, and any audits.
* Research data entry.
* Recruit, screen, and enroll patients as specified per protocol.
* Schedule patient visits and necessary testing.
* Process and ship blood, urine, and serum specimens.
* Obtain records and any other material required to complete case report forms and comply with protocols.

Qualifications: A BA/BS and 2 - 4 years clinical trial/clinical research experience; or equivalent. Effective problem solving abilities. Effective communication and writing skills. Knowledge of IRB and human research protection regulations Must have the ability to multi-task and be flexible. Should have excellent interpersonal skills and be able to work as part of several teams Must be able to direct his or her own work and is able to work independently.

Must pass Pennsylvania's Child Protective Services Act (also known as Act 73) within 30-90 days of employment.

Reference Number: 40-24924

Salary Grade: 026

Employment Type: Exempt

Org: DM-Renal-Electrolyte and Hypertension

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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