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Clinical Trial Operations Opportunities at Parexel

Clinical Trial Operations

Enrollment Specialist I

求人ID 55559BR ロケーション グレンデール, カリフォルニア州 仕事内容
Essential Function
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 Practice. Collect and organize research data. Educate participants about treatments and possible side effects and complications.

Key Accountabilities

• 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. 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.
• 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.
• Support the implementation and application of Clinbase w/n the department.
• 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.
• Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner
• Support Standard Operating Procedures (SOPs), Good Clinical Practices (GCP), and all work processes to ensure the efficient and compliant clinical operation of the EPCU.
• 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

Skills

• 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.


Education

• BS or Associate Degree preferred or relevant work experience.
• BLS certification preferred

Language Skills
• English
• Bilingual preferred (English and at least 1 of the following: Japanese, Chinese, Korean, Spanish)
Minimum Work Experience
• At least 1 year related experience preferred or relevant work experience.
• Computer skills and familiarity with research process is highly desirable.
• Physical Requirement: Manual dexterity, visual and auditory acuity.

EEO Disclaimer

PAREXEL 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.
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