Clinical Operation Assistant

Kiev, Ukraine
30 Apr 2021
30 May 2021
Clinical Research
Full Time
Contract Type
Experience Level
Experienced (non-manager)
Job Description

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 a Clinical Operations Assistant to be based in our Ukraine office.

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
  • Why Work at Parexel

    There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

    That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

    How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.

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