Closing Date: 13 Nov 16
Salary (£): Competitive
As a Research Operations Assistant you will support all site management team members on local billable administrative tasks in our Clinical Research management team in Paris. You will work closely with all local site management team members Clinical Research Associate (CRA), Clinical Monitoring Associate (CMA), Clinical Trial Specialist (CTS).
Research Operations Assistant (ROA)
PAREXEL International Corporation is a leading global bio/pharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Perceptive Informatics, Inc., a subsidiary of PAREXEL, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process. Headquartered near Boston, Massachusetts, PAREXEL operates in approximately 77 locations throughout over 50 countries around the world, and has more than 14,000 employees.
Research Operations Assistant (ROA)
The role of the Research Operations Assistant (ROA) 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.
CDS is also to support all site management team members on local billable administrative tasks and assist with QC of Central files.
• Assumes the ability to meet the requirements of a ROA with a high degree of proficiency
• Track, scan, code,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.
• 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
• Assist with the organization of translations of study document (e.g. contacting translation company,requesting approval via Oracle, following up with translation company to ensure timely delivery)
• Assist with payment/invoice processing including internal follow up with payment specialists in
• Assist with courier shipment of study document to the sites, vender and clients.
• Assist local site management team members with tracking/maintenance of the Clinical Trial
• Management System (CTMS) and study specific site trackers (Client additional request only)
• Assist with the collection of internal signatures for site documents (e.g. confidentiality agreement or
• clinical site agreements) within PAREXEL
• Good computer skills including but not limited to the knowledge of Clinical Trial/Data
• Maintain a basic knowledge and ensure compliance with applicable ICH-GCP Guidelines,
• international and local regulations and applicable PAREXEL procedures.
• Management Systems, PMED and MS-Office products such as Excel, Word
• 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
• Relevant qualification or equivalent experience required
• High school diploma – ideally degree in life science or other related background – preferred
• Good written English skills
Minimum Work Experience
• Experience in office management in an international environment would be advisable
101-105 Oxford Road
|Tel:||+44 1895 238000|
|Fax:||+44 1895 238494|
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