Sr. CRA 1 - Site Management

IQVIA LLC; Langley; On-site; GBP 42,000 - 62,000; Full time

Job summary

IQVIA is seeking an on-site Clinical Monitoring professional in Langley, United Kingdom, to perform site monitoring visits (selection, initiation, monitoring and close-out) in accordance with GCP, ICH guidelines, and the contracted scope of work.

You will drive subject recruitment plans, administer protocol training to sites, manage regulatory submissions and TMF/ISF documentation, and collaborate with the study team to address issues and timelines.

Qualifications

• Bachelor's degree preferred in scientific discipline or health care.
• Minimum 2 years of on-site monitoring experience.
• Good knowledge of GCP and ICH guidelines.
• Proficiency with MS Word, Excel, and PowerPoint.

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, CRF completion and submission, and data query generation and resolution.
• Ensure copies/originals site documents are available for filing in the TMF and verify the ISF is maintained per GCP and local regulations.
• Create and maintain documentation regarding site management, visit findings and action plans.
• Collaborate with study team members for project execution support.
• If applicable, support development of project subject recruitment plan on a per site basis.

Skills

On-site monitoring experience

Good communication

Organizational skills

Time management

Financial management

English proficiency

Education

Bachelor's degree in scientific discipline or health care

Tools

Microsoft Word

Excel

PowerPoint

Job description

• 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.
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
• If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement. Bachelor's Degree Degree in scientific discipline or health care preferred. Req
• Requires at least 2 years of on-site monitoring experience. Req
• 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.
• Good therapeutic and protocol knowledge as provided in company training.
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
• Written and verbal communication skills including good command of English language.
• Organizational and problem-solving skills.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
• IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at

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. We appreciate your honesty and professionalism.