Senior Clinical Research Associate – Oncology, Rare Disease

This is a fully remote position, open to applicants in Japan.

📋 Description

• Oversee site qualification, initiation, interim monitoring, site management, and study close-out visits.

• Provide mentorship and support to junior CRAs and site personnel as needed.

• Record findings from site visits through detailed written reports.

• Evaluate, monitor, and train study site personnel on adherence to protocols as necessary.

• Examine study subject safety information and informed consent documents.

• Perform source document verification to ensure compliance, patient safety, and data integrity.

• Review case report forms (CRFs) utilizing both paper and electronic data capture systems, assisting sites with data query resolution.

• Supply relevant updates for site-related documentation for inclusion in the Trial Master File (TMF).

• Guarantee site adherence to investigational product (IP) receipt, accountability, and proper return or destruction.

• Conduct accompanied site visits for the evaluation or training of other CRAs as requested and deemed appropriate.

⛳️ Requirements

• A minimum of 2 years of experience as a Clinical Research Associate.

• A bachelor's degree or an RN/BSN in Nursing.

• Experience in Oncology and Rare Diseases is necessary.

• Willingness to travel is required.

• Exceptional interpersonal, verbal, and written communication skills in English.

• Strong organizational abilities with a keen attention to detail.

• Capability to work independently with minimal supervision.

• Proficiency in Microsoft Office, CTMS, and EDC Systems.

🏝️ Benefits

• Health insurance.

• Retirement plans.

• Paid time off.

• Flexible work arrangements.

• Opportunities for professional development.