Make a Direct Impact in Hematologic Oncology
Parexel is a leading global clinical research organization (CRO) dedicated to advancing medical breakthroughs. We are seeking an experienced and highly motivated Senior Clinical Research Associate (CRA) with a specialized focus on Hematologic Oncology studies.
This is a unique, patient-facing role where you will be Parexel's primary contact with investigative sites in Japan. You will ensure the highest standards of data integrity, patient safety, and protocol compliance while building strong, collaborative relationships with site staff and investigators. Your expertise will be critical to the successful execution of vital clinical trials.
Mandatory Language Requirements: Professional working proficiency or above in both Japanese and Mandanda is essential.
Your Key Accountabilities
Site Management & Relationship Building (Initiation through Close-Out)
- Act as Parexel’s direct site contact, building strong, collaborative relationships with investigators and site staff to ensure protocol adherence and study integrity.
- Perform all types of monitoring visits (Qualification, Initiation, Routine, and Close-Out) as well as remote contacts, applying expert judgment to resolve site issues independently.
- Evaluate site performance, staff assignments, and recruitment strategies, providing actionable recommendations for improvement.
- Ensure sites are audit and inspection ready by maintaining compliance with ICH-GCP, local regulations, and study-specific plans.
Data Integrity & Operational Excellence
- Proactively identify, evaluate, and resolve potential data quality and integrity issues.
- Ensure timely and accurate data entry, query resolution, and safety (SAE) reporting follow-up.
- Manage all aspects of site documentation, including regulatory submissions and the maintenance of the Investigator Site File (ISF).
- Accurately update all Clinical Trial Management Systems (CTMS) and the Trial Master File (TMF).
Strategic Contribution & Collaboration
- Recognize the impact of site-level issues on overall study timelines and communicate critical matters that require immediate action.
- Work effectively within a global, matrixed team environment to meet project goals and deliverables.
- Mentor and provide guidance to administrative support staff as needed.
- Develop expertise to become a subject matter expert within Hematologic Oncology.
Your Profile: Qualifications & Experience
Education:
- Educated to a degree level in a biological science, pharmacy, nursing, or other health-related discipline (or possess equivalent qualification/experience).
Experience & Skills:
- Substantial Site Management experience or equivalent hands-on experience in clinical research, with a solid understanding of clinical trial methodology.
- Direct experience with Hematologic Oncology studies is highly preferred.
- Professional working proficiency (or above) in both Japanese and Mandarin is mandatory.
- Willingness and ability to accommodate extensive travel to sites in Japan as required.
- Strong problem-solving skills and the ability to work independently with minimal oversight.
- Excellent interpersonal, verbal, and written communication skills.
- High attention to detail, a sense of urgency, and effective time management.
- Proficiency with clinical systems (CTMS, EDC, IVRS) and MS Office.
Why Join Parexel?
At Parexel, we foster an inclusive environment where your expertise is valued, and your career can thrive. You will have the opportunity to work on cutting-edge oncology research that makes a real difference for patients worldwide.
- Impactful Work: Contribute directly to the development of new therapies for critical hematologic cancers.
- Professional Growth: Clear career pathways and opportunities to develop as a subject matter expert.
- Global Support: Be part of a supportive, collaborative international team.
- Competitive Compensation & Benefits: A comprehensive package reflecting your experience and skills.
If you are an experienced CRA with the required language skills and a passion for oncology research, we encourage you to apply.
Apply now to join our team as a Senior CRA for Hematologic Oncology studies.
Parexel is an equal opportunity employer. We welcome applications from all qualified individuals.
