Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do.We believe in our values; Patients First, Quality, Respect, Empowerment & Accountability.

We are currently looking for Clinical Operations Assistant (COA) to join the team in Turkey.This is a great opportunity where you will be trained in order to progress to a Clinical Research Associate role.

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 managementteam members on local billable administrative tasks and assist with QC of Central files.

Key Accountabilities

• 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 members (CMS) 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 PAREXEL

Qualifications :

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

Skills

• 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