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Parexel Early Phase Clinical Unit supports the development of innovative new medicines which are vital for public health, improving outcomes, and saving lives. The early phase and “first in human” trials are the first step in testing these novel treatments in humans. As a Clinical Enrollment Coordinator you will constantly learn and be exposed to different parts of the early phase unit. The Clinical Enrollment Coordinator works closely with research associates, call center agents, clinical research coordinators, etc. to ensure the enrollment process of study participants is completed safely while following standards and protocols.
Job Responsibility:
Screen potential clinical trial volunteers according to protocol specific requirements and CFR/ICH GCP guidelines
Ensure all study laboratory and medical tests are completed and the eligibility requirements specific to assigned studies are met
Ensure all established timelines relating to area of responsibility and assigned projects are met
Ensure completion of enrollment for assigned studies and manage process closely to minimize waste
Ensure quality control (QC) performance of all electronic and paper source documents
Assist in reviewing Informed Consent Documents, Study Protocols, Source Documents, and Case Report Forms during development
Ensure screening ratio and marketing expenditures are maintained within study specific budget
Participate in team project meetings and ensure regular updates for assigned studies
Develop and present training material to department staff for assigned studies
Arrange for pre/post procedure lab work to be performed and initiate follow up as required
Ensure follow up to all queries related to screening and enrollment of assigned studies
Collect, organize, and prepare data for physician review
Enter data into database when required
Ensure all paper source documents are completed as required by protocol
Assist physician with completing flow sheets in medical record and progress note
Update and maintain contents of the Clinical Study File
Support Standard Operating Procedures (SOPs), Good Clinical Practices (GCP), and all work processes to ensure the efficient and compliant clinical operation of the EPCU
Requirements:
Prior experience in clinical research enrollment and/or experience as a coordinator in either early-phase or late-phase clinical trials
A Bachelor’s degree
equivalent relevant work experience may also be considered
Nice to have:
Experience in immunology or autoimmune or oncology research
What we offer:
Paid time off
401k match
Life insurance
Health insurance
Other benefit offerings in accordance with the terms of applicable plans
Annual performance-based bonus plan (for eligible roles)
Annual salary review (for eligible roles)
Additional total rewards incentives (for eligible roles)