Start-up Specialist

Start-up Specialist

Contract length – initially 3 months

Rate - £35k-£40k hosted DOE

Location – London (hybrid)

Start date - ASAP

Are you a clinical professional with study start-up experience, open to new opportunities? If so, this position with one of our London based academia clients could be a great fit. You would be responsible for the efficient, timely delivery of the set-up of clinical trials and be a key point of contact for sponsor sites and stakeholders. The ideal candidate will be well organised, with strong communication skills, and able to work well in a team to tight deadlines.

Responsibilities:

·       Be familiar with the regulatory and ethics requirements for the conduct of clinical research (Research Governance Framework, ICH-GCP, and the processes of HRA)

·       Be responsible for obtaining permissions and local approvals with relevant departments  

·       Liaise with investigators to ensure sufficient capacity and resources for new projects

·       Take lead, coordinate, and track the timely completion of Feasibility and Expression of Interest 

·       Coordinate set-up meetings and Site Initiation Visits (SIVs)

·       Be responsible for creating Investigator Site File (ISF) and for the set-up of trials on the EDGE Research Management System

·       Help to determine timelines for study to set-up

·       Upon completion of site activation, provide accurate and concise handover

·       Communicate effectively with relevant stakeholders

·       Act as a key point of contact for the University with sponsor sites (Pharma, CRO & other universities)

·       Ensure any queries and questions are dealt with effectively

·       Schedule and coordinate documentation for the portfolio review meetings

·       Collate data for annual reports, monthly reviews of accrual data etc.

Required:

·       Demonstrable experience using Clinical Trial Research Management software e.g., EDGE

·       Previously used or understand how to use Integrated Research Application System (IRAS)

·       Understanding of ICH-GCP

If you are interested in this role, or know of someone in your network who could be, please reach out with an up-to-date CV to [email protected]