Emerging Clinical Research Associate

.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 members

• 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

• Collection of internal signatures for site documents (e.g. confidentiality

agreement or clinical site agreements) within PAREXELQualifications.• 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 strong knowledge and ensure compliance with applicable ICH-GCP Guidelines,

international and local regulations and applicable PAREXEL procedures and Client specific

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

• Effective problem solving skills

• Mentor and train less experienced staff as appropriate

• Good written English skills

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

• Relevant qualification or equivalent experience required