At a Glance
- Tasks: Monitor clinical trials and ensure compliance with regulations while supporting oncology studies.
- Company: Join a leading clinical research organisation making a real impact in healthcare.
- Benefits: Full-time role with opportunities for travel, professional growth, and continuous learning.
- Other info: Dynamic work environment with a focus on collaboration and innovation.
- Why this job: Make a difference in patients' lives while advancing your career in clinical research.
- Qualifications: Experience in oncology monitoring and knowledge of GCP and ICH guidelines required.
The predicted salary is between 35000 - 45000 £ per year.
The Clinical Research Associate will support Oncology studies and cover sites across the UK. Apply today and forge a career with greater purpose, make an impact and never stop learning!
Responsibilities
- 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. May support start-up phase.
- 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.
Requirements
- Experience of independent on-site monitoring of Oncology therapeutic area for unblinded studies.
- In depth knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Life science degree educated or equivalent industry experience.
- Flexibility to travel to sites as required.
Clinical Research Associate employer: SLAMcore
Join a forward-thinking organisation in Manchester that prioritises employee development and fosters a collaborative work culture. As a Clinical Research Associate, you will not only contribute to impactful Oncology studies but also benefit from ongoing training and career advancement opportunities in a supportive environment that values your growth and well-being.
We think you need these skills to ace Clinical Research Associate
Site Monitoring
Good Clinical Practice (GCP)
Oncology Knowledge
Regulatory Submissions
Data Query Generation
Trial Master File (TMF) Management
Investigator's Site File (ISF) Maintenance
