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Clinical Operation Assistant I

Parexel International Corporation

Shenyang Wobu, Liaoning, China

• 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, vendor and clients

• Collection of internal signatures for site documents (e.g. confidentiality agreement or clinical site agreements) within Parexel

• Assumes the ability to meet the requirements of a COA with a high degree of proficiency

• Effective time management in order to meet daily metrics or team objectives

• Able to work independently but seek guidance when necessary, escalating issues as required

QualificationsSkills:

• Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word.

• Maintain a basic knowledge and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations and applicable Parexel procedures

• Good oral and written communication skills to internal and external customer

• Ability to prioritize multiple tasks and achieve project timeline

• High commitment to and performs consistently high quality work

• Good written English skills

Knowledge and Experience:

• Experience in office management in an international environment would be advisable

Education:

• Relevant qualification or equivalent experience required

• High school diploma – ideally degree in life science or other related background - preferred

Job posted: 2022-06-17

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