At a Glance
- Tasks: Support Oncology studies by monitoring sites and ensuring compliance with regulations.
- Company: Leading clinical research organisation in Manchester, focused on innovative healthcare solutions.
- Benefits: Full-time role with competitive salary, travel opportunities, and professional growth.
- Other info: Dynamic team environment with opportunities for travel and career advancement.
- Why this job: Make a difference in cancer research while gaining hands-on experience in the field.
- Qualifications: Life science degree or equivalent experience; independent monitoring skills preferred.
The predicted salary is between 30000 - 40000 £ per year.
The Clinical Research Associate will support Oncology studies and cover sites across the UK.
- Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
- 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.
- Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) 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.
- Experience of independent on-site monitoring of Oncology therapeutic area for unblinded studies.
- Life science degree educated or equivalent industry experience.
- Flexibility to travel to sites as required.
Research Associate in Manchester employer: High5
As a leading employer in the clinical research field, we offer our Research Associates a dynamic work environment in Manchester, where innovation meets collaboration. Our commitment to employee growth is evident through comprehensive training programmes and opportunities for career advancement, all while fostering a supportive culture that values teamwork and excellence in Oncology studies. Join us to make a meaningful impact on patient care while enjoying the benefits of a flexible work schedule and a vibrant city lifestyle.
We think you need these skills to ace Research Associate in Manchester
Site Monitoring
Good Clinical Practice (GCP)
Subject Recruitment Planning
Protocol Administration
Communication Skills
Quality Evaluation
Regulatory Submissions Tracking
