Parexel

In this role the position will be based in India however will be working with teams in Japan and supporting the delivery of work in country. This would involve direct liaison with project teams, investigative sites and sponsors as might be required. All the communications would be expected to be done in Japanese and English- both written and verbal.

Job Purpose:

The role of the Clinical Operations Assistant (COA) is to maintain the paper and electronic Central Files for Clinical Operation, ensuring efficiency, accuracy and quality.

Depending on the location of the role may include the tracking, scanning, filing, entry and return of Case.

Report Forms to clients for assigned projects, upload and naming of documents to the electronic document management system, EDC User Management activities and activities associated with Impact

Harmony, as appropriate.

COA is also to support all site management team members on local billable administrative tasks and assist with QC of Central files.

Key Accountabilities:

Accountability Supporting Activities Project Central Files & Clinical Trial Management Systems Maintenance and Updates.

• Track, scan, code, and apply naming convention and send documents to

the relevant study Work In Progress (WIP) area and Central File (CF)

area of PMED as per the Central File Maintenance Plan.

• Filling and Archiving paper wet-ink documents in the Central Files office

location as per the Central File Maintenance Plan (CFMP)

• Photocopy, print distribute and retrieval of documents, as needed
• Maintain basic quality check procedures to ensure accurate maintenance

of documents

• Tracking/maintenance of the Clinical Trial Management System (CTMS)

and study specific site trackers (Client additional request only)

• Monitoring of the status of systems and processes (e.g. annual reporting

obligations, Site Compliance regarding Safety Information System (SIS)

etc.) to ensure compliance Support to all local site management team

Skills:

• N2, N3 fluency in Japanese (reading, writing, and speaking) Sound problem solving skills.
• Experience working in CROs or Life Sciences industry preferred.
• Support with document collection, customization, review for clinical trials being conducted in Japan. Liaise with sites & investigators on assigned projects to facilitate conduct and delivery.
• Work closely with project management teams on all assigned tasks.
• Ensure quality and compliance in all clinical research activities.
• Ability to interact professionally within a client organization.
• Ability to prioritize multiple tasks and achieve project timelines; utilizing strong analytical skills to make decision autonomously due to the unpredictable nature of the issues that arise.
• Strong interpersonal, verbal, and written communication skills.
• Sense of urgency in completing assigned tasks and ability to assist others to meet study/ country deliverables.
• Effective time management in order to meet study needs, team objectives, and department goals.

Knowledge and Experience:

• Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology

Education:

• Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience