Clinical Operations Assistant
Bucharest, Romania
‎în urmă cu 18 ore
source : Pharmiweb
  • Job Description*The role of the Senior Clinical Operations Assistant (Sr. COA) is to maintain the paper and electronicCentral 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 ofCase Report Forms to clients for assigned projects, upload and naming of documents to theelectronic document management system, EDC User Management activities and activities associatedwith Impact Harmony, as appropriate.

    Sr. COA is also to support all site management team members on local billable administrative tasksand assist with QC of Central files.

    Track, scan, code, and apply naming convention and send documents tothe 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 officelocation 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 maintenanceof 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 reportingobligations, Site Compliance regarding Safety Information System (SIS)etc.
  • to ensure compliance*Qualifications*

  • Strong computer skills including but not limited to the knowledge of a Clinical Trial ManagementSystem (CTMS), Electronic Document Management System (EDMS), and MS-Office productssuch 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 specificprocedures.
  • 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
  • Active participant as a process and / or platform Subject Matter Expert (SME) with minimal LMoversight.
  • Good written English skillsKnowledge and Experience :
  • Experience in office management in an international environment would be advisableEducation :
  • Relevant qualification or equivalent experience required
  • High school diploma - ideally degree in life science or other related background - preferred*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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