Clinical Operations Coordinator

1 week ago

Bengaluru, Karnataka, India Parexel Full time

Are you looking for a challenging and rewarding role in clinical research?

About the Job

We are seeking an experienced Clinical Operations Assistant to join our team at Parexel. In this role, you will be responsible for maintaining paper and electronic Central Files for Clinical Operation, ensuring efficiency, accuracy, and quality.

You will work closely with project management teams on all assigned tasks, ensuring quality and compliance in all clinical research activities. Your strong analytical skills and ability to prioritize multiple tasks will enable you to make decisions autonomously and effectively manage your workload.

Key Responsibilities
  • 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
  • Organization of translations of study document (e.g. contacting translation company, requesting approval via Oracle, following up with translation company to ensure timely delivery)
  • Payment/invoice processing including internal follow up with payment specialists in Finance
  • Courier shipment of study document to the sites, vender and clients
Requirements

To be successful in this role, you will need:

  • N2, N3 fluency in Japanese (reading, writing, and speaking) Sound problem solving skills.
  • Experience working in CROs or Life Sciences industry preferred.
  • Ability to interact professionally within a client organization.
  • Strong interpersonal, verbal, and written communication skills.
  • Able 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.

The estimated salary for this position is $65,000 - $85,000 per annum, depending on experience and qualifications.

Parexel offers a comprehensive benefits package, including health insurance, retirement savings plan, and paid time off. We also provide opportunities for professional growth and development, as well as a collaborative and dynamic work environment.

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