CRA/Senior CRA

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Job details

Company overview

Newly started domestic CRO, rapidly expanding in APAC and focusing on smaller to mid sized pharmaceutical companies looking to enter Japan/APAC

Responsibilities

Clinical Development Operations:

• Ensure that the trial sites are conducting the study/ project according to ICH-GCP, applicable SOPs and regulatory requirements and that subjects’ rights, safety and well-being are being protected.
• Primary point of contact of trial sites with regards to the conduct of the study/ project
• Perform site feasibility, site selection, initiation, monitoring and close-out visits according to the monitoring plan or scope of work
• Ensure that the sites are adequately trained on the protocol and other study specific requirements
• Write visit reports with the required information and ensure that this is finalized on a timely manner according to the monitoring plan
• Ensure that site contacts are adequately documented (e.g. through contact reports) and filed appropriately in the Trial Master File (TMF).
• Escalate issues to the CTM, Medical Monitor, Line Manager and/or Quality Assurance as necessary.
• Manage the progress of assigned studies/ sites by tracking regulatory submissions and approvals, recruitment and enrollment, electronic/case report form (e/CRF) completion and submission, and data query generation and resolution.
• Ensure adequate filing of study documents in the TMF and Investigator Site File (ISF)
• Track site budget and payments
• May be involved in preparation of status reports for clients
• Participate in Internal and External Meetings (such as Regular Project Teleconferences, Investigator Meetings, etc.) as necessary
• Act as mentor/coach to more junior staff as necessary
• Travel as necessary according to project needs
• Perform other duties as assigned by line manager.

Regulatory:

• Ensure study start up processes are done according to applicable SOPs and regulatory requirements.
• Prepare and submit regulatory and clinical documents to Regulatory Agencies and Independent Ethics committee (IEC)/Institutional Review Board (IRB)
• Ensure that product labels are compliant with applicable regulatory requirements
• Collect and submit necessary documents for study drug importation, return and/ or destruction
• Ensure that all documents necessary for site activation are collected

Requirements

• Bachelor’s degree in life science, chemistry, or health is preferred.
• ICH-GCP training is required
• Relevant experience on conduct of clinical trials
• Excellent communication, both written and verbal, and interpersonal skills
• Fluency in English is required
• Proficiency in MS Office programs

Salary

8 - 11 million yen

Location

Tokyo