At a Glance
- Tasks: Conduct site monitoring visits and ensure compliance with clinical research regulations.
- Company: Join IQVIA, a leading global provider of clinical research services.
- Benefits: Enjoy flexible working, career development, and well-being support.
- Other info: Be part of a growing team with excellent career growth opportunities.
- Why this job: Make a real impact in healthcare while advancing your career.
- Qualifications: 2 years of monitoring experience and a degree in a scientific discipline.
The predicted salary is between 51750 - 63250 £ per year.
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 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 (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.
Requires:
- At least 2 years 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 Harmonization (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.
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law.
Clinical Monitoring Associate in Bath employer: Iqvia Uk's Cfsp
IQVIA UK is an exceptional employer, offering a dynamic work culture that prioritises flexibility and professional growth. As part of the cFSP team in South West England, you will benefit from a supportive environment that encourages collaboration and innovation, while also providing opportunities for career advancement in clinical research. With a focus on high data quality and regulatory compliance, you'll find meaningful and rewarding work that makes a real impact in the healthcare sector.
