At a Glance
- Tasks: Conduct site monitoring visits and manage study progress in compliance with GCP and ICH guidelines.
- Company: Join a leading clinical research organisation based in London, UK, focused on innovative healthcare solutions.
- Benefits: Enjoy a full-time field-based role with opportunities for professional development and training.
- Other info: Position is not eligible for visa sponsorship; full UK right to work is required.
- Why this job: This role offers the chance to enhance predictability in subject recruitment and improve clinical trial outcomes.
- Qualifications: Requires 12 months of independent on-site monitoring experience and a degree in a scientific discipline.
The predicted salary is between 37000 - 45000 £ per year.
Location: London, United Kingdom | Full time | Field-based
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) and International Conference on Harmonisation (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 (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
- Requires at least 12 months independent on‑site monitoring experience of interventional studies.
- Experience across start‑up, enrolment, maintenance, close‑out.
- Digital literacy, including confidence using AI tools in a professional setting.
- Degree in scientific discipline / health care or equivalent industry experience.
- Good knowledge of, and skill in applying, applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines.
- Ability to establish and maintain effective working relationships with coworkers and clients.
- Full UK right to work required; this position is not eligible for visa sponsorship.
Clinical Research Associate II, South East England employer: IQVIA Argentina
Work in London with a top-tier clinical research organisation that values innovation and quality. Benefit from a supportive environment that encourages professional growth and offers comprehensive training. The team is dedicated to adhering to the highest standards of clinical practice.
We think you need these skills to ace Clinical Research Associate II, South East England
Site Monitoring
Good Clinical Practice (GCP)
International Conference on Harmonisation (ICH) guidelines
Subject Recruitment Planning
Protocol Administration
Regulatory Submissions and Approvals
Case Report Form (CRF) Management
