Senior Study Start Up Specialist/Initiation CRA - Freelance UK

Senior Study Start Up Specialist/Initiation CRA - 6-month contract - Global CRO

i-Pharm Consulting are seeking on behalf of a Global CRO a freelance Senior Study Start-Up Specialist/Initiation CRA. Our client is a leader in clinical research and development and has strong relationships with a large number of global pharmaceutical companies.

THE ROLE:
Initial 6 month contract with the potential to extend. To manage the Start-up of UK/Ireland clinical trials from site identification through pre-initiation. The ideal candidate is already a contractor and can start within 1 month however we can consider permanent candidates willing to make the move to contracting but you must be available within 6-8 week maximum.

Other duties include:

• Responsible for clinical trial set up including;
• Build relationships with site staff and investigators ready for the planned SIV
• Develop strategy to configure, distribute and collect country and site-specific documents and essential regulatory documents
• Customise, review, and negotiate ICFs
• Coordinate country submissions
• Ethics Submissions
• Regulatory Submissions
• Support coordination of feasibility
• Negotiate site budgets
• Collaborate with Regulatory and Contracts departments to ensure delivery of country and site plans

LOCATION:
Home Based - Greater London region

RATE:
Competitive Daily Rate

REQUIRED:

• Life sciences degree
• 4+ years within Pharmaceutical/CRO industry in SSU/CRA/Regulatory positions
• Must have recent 2+ years managing EC submissions in the UK and/or Ireland (essential)
• Good knowledge of clinical research processes including ICH GCP
• Advanced level knowledge and use or IRAS system/Amendment tool

ABOUT i-PHARM CONSULTING:
i-Pharm Consulting is a specialist Recruitment Company servicing the Pharmaceutical industry in the UK and Europe. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organisations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance and Bioinformatics.
www.i-pharmconsulting.com

TO APPLY:
If you would like to discuss this vacancy further, please call Lauren McQuade on +44(0)2031890488, or email lmcquade@i-pharmconsulting.com. If this role is not suitable, Lauren is also available to discuss other possible positions or answer any general questions regarding your career and the current market.

KEYWORDS:
SSU / Study Start Up / Start Up / Ethics / Regulatory / Country Approval Specialist / CAS / Submissions / Site Contracts / CTAs / Clinical Trial Agreements / Feasibility / Freelance / Contract / CRO / Clinical Research / Clinical Research Organisation / Pharma / London i-Pharm / Home Based / UK / London / Greater London / Essex / Berkshire / Surrey / Buckinghamshire / Luton / Cambridge / Field Based / Remote / Home Working / WFH