Parexel
Overview
Clinical Enrollment Coordinator (Japanese Fluent) at Parexel. The role supports the early phase clinical unit and involves enrolling study participants while ensuring safety and adherence to standards and protocols. This position offers extensive induction and ongoing training and a defined career path within Parexel's Early Phase Clinical Unit. What you’ll do after training
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 related to area of responsibility and assigned projects are met. Ensure completion of enrollment for assigned studies and manage the process to minimize waste. Ensure quality control (QC) of all electronic and paper source documents. Assist in reviewing Informed Consent Documents, Study Protocols, Source Documents, and Case Report Forms during development. Maintain screening ratios and marketing expenditures within study-specific budgets. Participate in team project meetings and provide regular updates for assigned studies. Develop and present training material to department staff for assigned studies. Arrange for pre/post procedure lab work and initiate follow up as required. Provide follow up to all queries related to screening and enrollment of assigned studies. Collect, organize, and prepare data for physician review. Enter data into the database when required. Ensure paper source documents are completed as required by protocol. Help physicians complete flow sheets in medical records and progress notes. Update and maintain contents of the Clinical Study File. Support Standard Operating Procedures (SOPs), Good Clinical Practices (GCP), and all work processes to ensure efficient and compliant clinical operation of the EPCU. Your Profile
Prior experience in clinical research enrollment and/or experience as a coordinator in early-phase or late-phase clinical trials. Highly Preferred: Experience in immunology or autoimmune research. Bilingual proficiency in both spoken and written Japanese and English – required. A Bachelor’s degree; equivalent relevant work experience will also be considered. Compensation and Benefits
Base Pay Range:
$25.00 to $34.00 per hour Actual salaries may vary within the range based on several factors including, but not limited to education, training, experience, professional achievement, and location. In addition to base salary, some roles may be eligible for participation in Parexel’s annual performance-based bonus plan, annual salary review and additional total rewards incentives. Our talent acquisition team will provide additional details on bonus plans or incentive programs for eligible roles. We offer market-leading benefit programs including paid time off, 401k match, life insurance, health insurance, and other benefits in accordance with applicable plans. Job Details
Seniority level:
Associate Employment type:
Full-time Job function:
Education and Training Industries:
Pharmaceutical Manufacturing, Biotechnology Research, and Hospitals and Health Care
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Clinical Enrollment Coordinator (Japanese Fluent) at Parexel. The role supports the early phase clinical unit and involves enrolling study participants while ensuring safety and adherence to standards and protocols. This position offers extensive induction and ongoing training and a defined career path within Parexel's Early Phase Clinical Unit. What you’ll do after training
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 related to area of responsibility and assigned projects are met. Ensure completion of enrollment for assigned studies and manage the process to minimize waste. Ensure quality control (QC) of all electronic and paper source documents. Assist in reviewing Informed Consent Documents, Study Protocols, Source Documents, and Case Report Forms during development. Maintain screening ratios and marketing expenditures within study-specific budgets. Participate in team project meetings and provide regular updates for assigned studies. Develop and present training material to department staff for assigned studies. Arrange for pre/post procedure lab work and initiate follow up as required. Provide follow up to all queries related to screening and enrollment of assigned studies. Collect, organize, and prepare data for physician review. Enter data into the database when required. Ensure paper source documents are completed as required by protocol. Help physicians complete flow sheets in medical records and progress notes. Update and maintain contents of the Clinical Study File. Support Standard Operating Procedures (SOPs), Good Clinical Practices (GCP), and all work processes to ensure efficient and compliant clinical operation of the EPCU. Your Profile
Prior experience in clinical research enrollment and/or experience as a coordinator in early-phase or late-phase clinical trials. Highly Preferred: Experience in immunology or autoimmune research. Bilingual proficiency in both spoken and written Japanese and English – required. A Bachelor’s degree; equivalent relevant work experience will also be considered. Compensation and Benefits
Base Pay Range:
$25.00 to $34.00 per hour Actual salaries may vary within the range based on several factors including, but not limited to education, training, experience, professional achievement, and location. In addition to base salary, some roles may be eligible for participation in Parexel’s annual performance-based bonus plan, annual salary review and additional total rewards incentives. Our talent acquisition team will provide additional details on bonus plans or incentive programs for eligible roles. We offer market-leading benefit programs including paid time off, 401k match, life insurance, health insurance, and other benefits in accordance with applicable plans. Job Details
Seniority level:
Associate Employment type:
Full-time Job function:
Education and Training Industries:
Pharmaceutical Manufacturing, Biotechnology Research, and Hospitals and Health Care
#J-18808-Ljbffr