Please remember on the JD they will only do the ?Start-up (from site identification through pre-initiation?) not the Maintenance (from initiation through close out) parts. These tasks are done by the CRA. We are looking for a dedicated and focused SSU Specialist. The Brief below gives a better outline of the roles.
We are looking for the Study Start Up Specialist (either at II or Sr level) to focus on the Country Feasibility aspects of the SSU role and for the other role to concentrate on UK EC submissions. If people have done both that is great but if they enjoy or specialise in one more then that is fine.
The team have also said for experienced people they can possibly allow for fully home based working if this helps.
If one of the two roles can have someone with a lot of experience on EC submissions and the other then has more Country Feasibility experience that would be great.
· Working as part of the UK Clinical Operations group of approx. 100 people in the UK.
· Working as part of the smaller subgroup of 20 in the study start up team dedicated to SSU tasks.
· Reports to the Senior Manager Clinical Operations
· Need to be highly skilled and experienced in UK study start up tasks and have full accountability and ownership of the task/process and their delivery (not a supporting role).
We also do not want a CRA who has done or supported part of these tasks or overseen these tasks.
They need to be fully responsible for this and have done SSU as a direct focused 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.
· Ideally 4-5 years+ study start up experience working in the CRO environment as a Senior Study Start Up Specialist for Sr ICRA
· Ideally 2-3 years + study start up experience working in the CRO environment as a Senior Study Start Up Specialist for ICRA II
· 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 or Strong Country Feasibility experience
· Advanced level knowledge and use or IRAS system/Amendment tool.
- Agency: Achieva Group Limited
- Contact: Lewis Coulson
- Phone: 01727 817 626
- Reference: BH-5999
Website: Achieva Group Limited
- Posted: 10th February 2021
- Expires: 10th March 2021