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.
Qualifications: Minimum of a High School diploma and 3 to 5 years of experience or an equivalent combination of education and experience required. College degree or coursework strongly preferred. Knowledge of medical terminology is required. 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 is a plus.
Reference Number: 40-28284
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