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• Flexible working schedule

• Obtain and maintain essential documentation in compliance with ICH-GCP, TFS procedural documents and local regulations both in trial master file (TMF) and investigator study file (ISF).
• Actively participate in local study team meetings.
• Contribute to the selection of potential investigators.
• Train, support and advise investigators and site staff in study related matters.
• Contribute to national investigators meetings.
• Initiate, monitor and close study sites in compliance with TFS procedural documents. Share information on patient recruitment and study site progress within local study team.
• Drive performance at the sites. Proactively identify study-related issues, solutions and escalate as appropriate.
• Update CTMS and other systems with data from centers as per required timelines.
• Manage study supplies (ISF, CRF, etc), drug supplies and drug accountability at study sites.
• Perform source data verification according to SDV plan.
• Oversee data query resolution by the site.
• Verify accurate and timely reporting of serious adverse events.
• Prepare for activities associated with audits and regulatory inspections in liaison with local study delivery team lead and CQM.
• Provide the required monitoring visit reports within required timelines.
• Support and work together with lead CRA, LSM and regulatory affairs to see to timely delivery of study documents for submissions to RA and EC.
• Contribute to financial agreements with relevant staff at investigational site in collaboration with lead CRA and/or LSM.
• Oversee timely preparation of country specific CSA in collaboration with LSM and/or lead CRA.
• Verify compliance with TFS’s code of conduct and company policies and procedures relating to people, finance, technology, security and safety, health and environment.
• Track and manage agreed payments at study site level.
• Participate in training and mentoring of new members of the local study team verifying compliance with ICH/GCP and TFS procedural documents.

• Bachelor’s Degree, preferably in life science or nursing; or equivalent
• Previous experience as CRA including relevant independent on-site monitoring
• Study experience in any of the following therapeutics areas: Oncology, Cardiovascular, Renal and Metabolism, Respiratory or Immunology.
• Able to work in a fast paced environment with changing priorities
• Understand the basic medical terminology and science associated with the assigned drugs and therapeutic areas
• Possess the understanding of Good Clinical Practice regulations, ICH guidelines
• Ability to work independently as well as in a team matrix organization
• Excellent written and verbal communication skills
• Excellent organizational skills
• Open for possibility for national travel

TFS HealthScience does not discriminate on the basis of race, sex, color, religion, age, national origin, marital status, disability, veteran status, genetic information, sexual orientation, gender identity or any other reason prohibited by law in provision of employment opportunities and benefits.