Lead CRA - Permanent role
Global CRO based Berkshire
Our client is an established and privately held leading CRO with multi-national presence in over 40 countries. Our client delivers cost-effective, quick-to-market clinical services in emerging and traditional markets of research along with experience in a broad range of therapeutic areas and phases of development. Their CRAs average over 6 years of monitoring experience and the majority of our clinical staff in emerging markets are physicians or PhD's. Our client's data services integrate randomization into EDC systems, eliminating IVRS costs, with added benefit of full inventory control over supplies.
To operate as the focus for communication with Clinical Research Associates (CRAs) and the Sponsor. Act as the lead contact of the project team with study site personnel and ensure that the clinical trial is conducted in accordance with international Regulatory and Ethical guidelines for Good Clinical Practice.
Support the Project Manager with the day-to-day functional and organisational activities of clinical trial management.
Liaise with CRAs and Sponsor to track study progress and milestones; regulate quality^standards; resolve logistical and practical issues, and promote the team.
Establish regular communication with CRAs and CROs, and assess the quality, timeliness and expenditure for the Clinical Trial.
Provide functional assistance to project team^members with administrative, logistical and practical issues, including collection, distribution and filing of relevant study documentation.
Identify potential logistical / practical problems and propose solutions / contingency plans, with costing's^and time frames for resolution.
Supervise generation of electronic tracking systems and paper logs, and the ongoing collection of data, for the production of status updates / progress reports, including patient recruitment and withdrawal, SAE's, CRF and data query transmission.
Review study related documentation for compliance with SOPs and ICH-GCP Guidelines, particularly Regulatory / Ethics Committee review and approval, CVs, drug accountability, translations, SAE reports, etc.
Alert Medical Adviser / Director and Project Manager immediately on receipt of SAE report from study site, prior to forwarding to the Sponsor (where necessary).
Assist the Project Manager with generation of study specific forms for completion by CRAs and Investigators.
Follow-up Sponsor's requests for clarifications; supplementary information; distribution of newsletters and review approval of protocol amendments; financial disclosures, Clinical Investigator Brochure revisions; translations etc.
Participate in contract negotiations with central laboratories, couriers and other external organisations, e.g. sub-contractors for printing, monitoring, data processing, external quality assurance, etc.
Organise processes for interim and final payments to^Investigators, including preliminary calculations, review and approval from project management, liaison with POI accountant, logging trial expenditure, receipts, invoices and income.
Process and track payments to the Ethics Committees, Regulatory Authorities,
Assists the Project Manager with drafting and writing the Monitoring Guidelines and Clinical Job Description: CRA I, II, III, SCRA I and II 2008 the Project Plan. Present as required at Sponsor or POI led meetings to support the PM with^on-going study training requirements.
Essential Skills & Qualification
Excellent Communication skills
Good Presentation skills
Co-ordination skills in conducting a project in all aspects
Experienced in conducting allocated tasks
Maintain up-to-date knowledge of ICH-GCP, EU CT Directive and FDA guidelines
Experience in SCRA at grade I level
Excellent knowledge of Regulatory requirements
Ability to create and review accurate study documents
Ability to prioritise all activities related to team activities
Work both independently and as part of the team
Good computer skills and able to create tracking documents
Demonstrates exceptional inter-personal skills
Ability to problem solve and delegate tasks appropriately
Software Competence: MS Packages
Valid Driving License: Essential
Working Language(s): English
Requirement for Business Travel: Yes
Flexible Working Hours: To be confirmed
Employment Type: Permanent
Hours: Full time
Location: UK; Berkshire
Plan Start Date: Negotiable
Company Pension, Car Allowance, Life Insurance, Private Healthcare Package Plan, Bonus
Clinical Research, Clinical^Operations, Clinical R&D, CRA, CTM, GCP, Site Manager, Monitor, Manager,, GCP, Clinical Study, Feasibility , Essential Documents, GCP, SOPs, Compliance, Training, Investigator Meeting, REC, Research Ethics. R&D, Trust, SMO, Site Manager, Budget, ven