CRA 2 - Single Sponsor Dedicated

IQVIA LLC; Langley; On-site; GBP 40,000 - 70,000; Full time

Job summary

IQVIA LLC is seeking an on-site monitoring professional to ensure adherence to GCP and protocol requirements across multiple sites. You will manage site communications, training, and issue resolution while tracking regulatory submissions and data queries throughout the study lifecycle.

The role requires at least 1 year of on-site monitoring experience, strong knowledge of GCP/ICH guidelines, and proficiency in Word/Excel/PowerPoint.

Qualifications

• Bachelor's degree in scientific discipline or healthcare preferred.
• Requires at least 1 year of on-site monitoring experience.
• Good knowledge of Good Clinical Practice (GCP) and ICH guidelines.
• Proficiency in Microsoft Word, Excel and PowerPoint.
• Written and verbal communication skills in English.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) per contracted scope and GCP.
• Drive and track subject recruitment plans to enhance predictability.
• Administer protocol training to sites and maintain regular communication to manage expectations and issues.
• Ensure site practices comply with protocol and regulatory requirements; escalate as needed.
• Track regulatory submissions, recruitment, CRF completion and data queries; support start-up phase if needed.
• Maintain TMF/ISF documents and ensure regulatory filing per local requirements.
• Create site management documentation and submit regular visit reports and follow-up letters.

Skills

English communication

Organizational skills

Problem solving

Time management

Financial management

Relationship building

Education

Bachelor's Degree in scientific discipline or healthcare

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 1 of year of on-site monitoring experience. Req
• Equivalent combination of education, training and experience may be accepted in lieu of degree. 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.