Contract Senior Initiation Clinical Research Associate – CRO – UK/remote - £Competitive daily rate
Large global CRO who supports medical devices and biopharma industries in the development and commercialisation of all new therapies and products.
- UK Clinical Operations group of approx. 100 people within the UK
- Working as part of the smaller subgroup of 20 in the study start up team
- 35 year heritage
- Global CRO who have helped develop 95% of the top 200 best selling biopharmaceuticals on the market
- Is highly skilled and experienced in UK study start up tasks and has full accountability and ownership of the task/process and there delivery (not a supporting role).
- Study teams main point of contact for the generation of country/site plans and the SSU delivery (country and sites).
- Build relationships with investigators and site staff for the management of Qualification follow-up/ site issues, site training/accesses, supplies and investigator site file set up (alongside SRP) ready for the planned SIV.
- Develop strategy to configure, distribute, and collect, and review and approve, high quality country specific and/or site specific documents or essential regulatory documents (SRP) and any updated or amended regulatory documentation. With ongoing SRP First Time Quality (FTQ) visibility tracked as a country metric.
- Customize, review, and negotiate as needed, country/site specific Informed Consent Forms (ICF) and customize and negotiate any amendments.
- Prepare and submit IRB/IEC resolving conflicts, determining appropriate follow up until receipt of final approval, which includes knowledge of the parallel submission i.e. ARSAC, PPI plus other UK specific processes applicable for CTIMPs. Also required to manage ongoing study EC amendments.
- Generate contact reports, using judgment to identify site issues and problem solving to direct resolution.
- Collaborate with other functions to ensure delivery of country and site plans (i.e. Regulatory and Contracts)
- File according to the study Essential Documents listing/CFMP in real time via Veeva/IMPACT.
- Track via an end to end workflow system which provides full transparency of task status, and built in tracking to plan for wider Clinical Team/Leadership oversight
It is essential you can meet the below:
- Ideally 4-5 years' + study start up experience working in the CRO environment as a Senior Study Start Up Specialist
- Senior in mentality, solid work ethic and professional client approach, with customer / client focused due to the virtual internal team and site contacts.
- Previous CRO / Pharma industry experience is essential
- Must have strong EC submission experience
- Advanced level knowledge and use or IRAS system/Amendment tool.
- Substantial Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology
What should you do next?
Unless otherwise stated, if applying for a job within the European Union, you must ensure that you are already authorised to work there.
Carrot Pharma Recruitment Ltd acts as an Employment Business and an Employment Agency on behalf of our client in recruitment for this role.