Study Start-up Specialist

2 weeks ago

London, United Kingdom Cpl Life Sciences Full time

**Reference Number**: JO-2303-512814

Study Start-up Specialist

**Rate**: Negotiable

**Job Type**: Contract

**Location**: London City

Start-up Specialist

Contract length - initially 3 months

Rate - £35k-£40k hosted DOE

Location - London (hybrid)

Start date - ASAP

**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

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