Due to expansion, TMC are looking to hire a UK based experienced Senior CRA. As our specialisms are Rare and Orphan diseases and Oncology, experience in these areas is essential to the successful candidate.
Responsibilities
* Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) E6 R3 and International Conference on Harmonization (ICH) guidelines
* Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability
* Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues
* Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate
* Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase
* Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (eTMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements
* Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation
* Collaborate and liaise with study team members for project execution support as appropriate
Requirements
* A minimum of 4-5 years of independent on-site monitoring
* You have successfully managed multiple clinical trial protocols across diverse investigative sites.
* In depth knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
* Life science degree
* Flexibility to travel to sites
* A range of therapeutic area experience including oncology and rare and orphan diseases
Whilst the role is remote based, we will expect regular visits to the Head Office in Hartley Wintney, Hampshire.
A driving licence is essential.
*Please note - this role is not eligible for UK visa sponsorship*