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 Division of Rheumatology with a particular focus on clinical trials for new therapeutics for the treatment of scleroderma and vasculitis. The primary duties for the Clinical Research Coordinator A will include, but are not limited to:
* 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.
* Coordinate acquisition of tissue samples and copies of radiographs from other academic medical institutions and help investigators conducting a series of projects related to Systems Biology.
* 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.
The Clinical Research Coordinator B will undertake the duties outlined for the Clinical Research Coordinator A position, with the additional expectation that the candidates will develop novel solutions to research questions in addition to employing only established methods. Moreover, it is expected that the Clinical Research Coordinator B candidate will have more clinical research experience than the Clinical Research Coordinator A candidate, such that (s)he can make greater contributions to the research program, and coordinate multiple Phase I-IV clinical trials. The Clinical Research Coordinator B will work with federal or private sponsors, pharmaceutical companies and CROs. (S)he will assist with preliminary budget proposals and complete perspective reimbursement analyses.

Qualifications: CLINICAL RESEARCH COORDINATOR A: BA/BS and 1 to 3 years clinical trial/clinical research experience or equivalent combination of education and experience 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. Position contingent upon funding.

CLINICAL RESEARCH COORDINATOR B: Same as above with 2 to 4 years of experience or equivalent combination of education and experience.

Reference Number: 40-25951

Salary Grade: 025/026

Employment Type: Exempt

Org: DM-Rheumatology

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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