Enrollment Specialist I
Parexel International Corporation
A business critical role ensuring that enrollment for all clinical research studies conducted is completed on-time and in compliance with sponsor protocols, Good Clinical Practice (GCP), EPCU Standard Operating Procedures (SOPs), and any other applicable regulations.
-Continuously monitor recruitment progress, screening ratios, and enrollment rates to ensure on-time and profitable enrollment of all clinical research studies.
-Attends and presents material at client meetings or scientific meetings to support the acquisition of new business, as needed, with a particular focus on enrollment.
-Reviews feasibility of proposed studies and provides advice on improving suitability of inclusion and exclusion criteria for recruitment, efficiency, ease of conduct, and costs.
-Develop volunteer recruitment strategies, to include a marketing plan, community outreach initiatives, etc. for assigned projects and /or populations of interest.
-Execute and actively participate in study specific and special population recruitment efforts, study-specific marketing, community outreach (i.e. language schools, community centers, senior centers, markets, etc.).
-Screen potential clinical trial volunteers according to protocol specific requirements and CFR/ICH GCP guidelines
-Ensure quality control (QC) performance of all electronic and paper source documents.
-Ensure that all established timelines relating to areas of responsibility are met.
-Perform ECG/EKG, vital sign measurements, and rating scales, reporting abnormal results to appropriate staff as required.
-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.Qualifications•Must have excellent organizational skills.
•Excellent interpersonal, verbal, and written communication skills.
•Must be self-directed and work with minimal supervision.
•Client focused approach to work.
•A flexible attitude with respect to work assignments and new learning.
•Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.
•Willingness to work in a matrix environment and to value the importance of teamwork.
•Physical Requirement: Manual dexterity, visual and auditory acuity.
•Computer skills and familiarity with research process is highly desirable.
•BS or Associate Degree preferred or relevant work experience.EEO DisclaimerParexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.