Ref #: 29333

Employment type: Permanent - Full-Time

Location: United Kingdom

Posted: 24-May-2021

Description

The role we have is permanent through DOCS and contracted to the client indefinitely so this is a permanent role with great stability. It is also home-based reporting to the High Wycombe in Buckinghamshire for training and meetings.

The role will suit and experienced CRA wanting to utilse their transferable skills within a reputable pharma or a Clinical Trial Monitor/Clinical Trial Manager working within academia/NHS who have the onsite monitoring experience and ready to take the next step into the commercial world.

Responsibilities:

• Participates in site feasibility and/or pre-trial site assessment visits, providing recommendation from local area about site/investigator selection in collaboration with the trial team
• Acts as primary local company contact for assigned sites for specific trials.
• Attends/participates in investigator meetings as needed.
• Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out according to internal SOPs and policies.
• Ensures site staff is trained and the corresponding training records are complete and accurate at any time point during all trial phases.
• Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
• Ensures site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct.
• Ensures that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents.
• Maintains complete, accurate and timely data and essential documents in systems utilized for trial management (e.g. CTMS, eTMF/IF, Trial Master Source and Sharepoints).


Qualifications/Experience:


• A minimum of a BA/BS degree is required. A degree in a health or science related field is preferred.
• Must have experience in Clinical Research or equivalent qualification
• 1-2 years experience monitoring on site
• Specific therapeutic area experience may be required depending on the position.
• Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
• Strong IT skills in appropriate software and company systems.
• Proficient in speaking and writing the country language and English.
• Good written and oral communication skills.
• Must have a UK drivers license and a car
• Must have the right to work in the UK as we do not provide sponsorship

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