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Enrollment Specialist II

Parexel International Corporation

Baltimore, Maryland

Organize, execute, and coordinate the enrollment process of clinical research studies, including all activities from recruitment to admission. Ensure that protocols are implemented and followed according to Good Clinical Practices (GCPs), EPCU Standard Operating Procedures (SOPs), and any other applicable regulations. Collect and organize research data. Educate participants about treatments and possible side effects and complications.

•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.).

•Coordinate and assume responsibility for participant enrollment, care, and study assignment.

•Screen potential clinical trial volunteers according to protocol specific requirements and CFR/ICH GCP guidelines.

•Coordinate with the Investigator team to 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.

•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.

•Provide support, mentorship, and training to Enrollment team.

•Maintain contact with sponsor team members and participate in relevant meetings (may require travel), as needed.

•Assist with the creation, review, revision, and/or retirement of Standard Operating Procedures, as assigned. Also participate in implementation and training once finalized.

•Participate in team project meetings and provide regular updates for assigned studies.

•Develop and present training material to department staff for assigned studies.

•Support the implementation and application of ClinBase™ w/n the department.

•Support Standard Operating Procedures (SOPs), Good Clinical Practices (GCP), and all work processes to ensure the efficient and compliant clinical operation of the EPCU.

•Undertake the full range of duties relevant to the management and development of the team to ensure their performance meets and or exceeds both the business and personal goals/objectives

•Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner

•Participate in formal staff review processes e.g. performance and salary reviews to corporate standards and timescales.

•Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and is not to be considered as all inclusive.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.

•At least 2-4 years related experience or relevant work experience.

•Computer skills and familiarity with research process is highly desirable.

•BS or Associate Degree preferred or relevant work experience.

•BLS certification preferredEEO 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.

Job posted: 2020-08-11

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