Company: DOCS Global
Location: Cambridge,United Kingdom
Reference: Ref AS-019517
Closing Date: 24 Oct 16
Salary (£): Competitive
Benefits: Excellent & Comprehensive
Why this Vacancy is right for you • Established and successful company; Please send your application* with your most recent CV today to find out more about this career opportunity to Elisabeth.Knighton@docsglobal.com or ring either +33 964 25 67 65 *Applicants who have not had a response within two weeks should assume their application has been unsuccessful. Key Words CTA / Clinical Trial Assistant / Clinical Trial Administrator / Study...
Roles & Responsibilities of the position
The CTA/The Clinical Trial Assistant
• Is responsible for study start up activities and coordinates preparation of local study documentation relating to: clinical study timelines for all studies conducted in a country, recruitment plans and strategy, informed consent form, draft clinical metrics reports;
• Coordinates the preparation of the submissions and local tracking of applications;
• Ensures collection, review, track and provision of appropriate clinical documents to support regulatory submission;
• Develops and maintains an effective relationship with local Regulatory Affairs to ensure consistent working practices for various submissions;
• Ensure safety reports are submitted to central Research Ethics Boards;
• Initiates and validates payment requests as required, ensuring that payment requests are within contract and based on milestones;
• Prepares and maintains local study documentation relating to Site Initiation Package (SIP) requirements (coordinates activities associated with start-up including updating systems), Amendments, Clinical study timelines and ICF;
• Collates and completes SIP, reconciles study documents, collates study specific data and generates local metrics reports, coordinates local data entry into study management systems and creates and completes tracking documentation as applicable;
• Processes, distributes and tracks essential documents and submits them to the relevant department or local archive in compliance with the company’s SOPs;
• Prepares and tracks confidentiality agreements;
• Collates and distributes study supplies to sites; provides support to responding to local audits and inspections; responds to clinical trial queries;
• Orders, processes and tracks Case Report Forms (CRF) and follows-up on query resolution;
• Acts as a single contact point for Clinical Trials Insurance process;
• Completes tracking documentation as applicable including but not limited to spreadsheets.
• Ideally BA/BS/BSc or qualified nurse
• UK-based clinical trial co-ordination/administration experience gained within the clinical research industry or within NHS trust/hospital setting
• Proven ability to work efficiently and accurately with MS Office and EDC systems
• Ability to work effectively to fast-moving timelines within a fast-paced working environment using different electronic systems
• Excellent and accurate attention to detail
• Valid, current UK working eligibility
• Must be able to start within 1 or 2 months
This is an excellent career opportunity for clinical trial administrator/coordinator to move up to CTA level.
• Full-time career opportunity with career progression
• Market-leading salary will be offered depending on level of experience and skills
• Permanent contract of employment with company perks and benefits
• Company benefits to include 23 days annual leave plus UK bank holidays, pension, medical health insurance, etc.
• Office-based in Cambridge (UK)
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