CLINICAL RESEARCH ASST B
Duties: We are looking for a highly motivated, dedicated and enthusiastic individual who will provide study coordination for patient-oriented clinical and translation research projects within the Renal Division. The primary duties will include, but are not limited to:
* Assist with Institutional Review Board (IRB) documentation including submissions, continuing reviews, amendments, and adverse event reporting.
* Assist, process, file, and organize all regulatory documentation.
* Assist in the coordination, organization, and maintenance of all documentation required by sponsor or clinical research organizations (CROs) - source documentation, case report forms, study and regulatory binders, and patient binders.
* Assist in resolving 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.
Position is contingent on continued funding.
Qualifications: The minimum of a High School diploma and 3 to 5 years of experience or an equivalent combination of education and experience is required. Associate's degree with background in science and 2 - 4 years clinical trial/clinical research experience, or Bachelor's degree, strongly preferred. A minimum of 1-2 years of experience in a healthcare setting is required; knowledge of medical terminology required. Venipuncture certification preferred. Effective problem solving abilities. Effective communication and writing skills. Ability to multi-task. Demonstrated ability to work as part of a team as well as independently. Knowledge of IRB and human research protection regulations.
Must pass Pennsylvania's Child Protective Services Act (also known as Act 73) background checks within 30-90 days of employment.
Reference Number: 40-25703
Salary Grade: 024
Employment Type: Non-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: 6-Technical Scientific/Statistical