At a Glance
- Tasks: Monitor clinical sites and ensure compliance with study protocols in Oncology research.
- Company: Join a leading organisation dedicated to advancing healthcare through innovative research.
- Benefits: Full-time role with opportunities for travel, professional growth, and impactful work.
- Other info: Dynamic role with a focus on continuous learning and collaboration.
- Why this job: Make a real difference in patient care while developing 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 Β£ 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 in Chesterfield employer: SLAMcore
Join a forward-thinking organisation in Chesterfield 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 in Chesterfield
Communication Skills
Problem-Solving Skills
Teamwork
Organizational Skills
Compassion
Flexibility
Adaptability