Clinical Research Associate II (CRA II)

IQVIA LLC; Salford; On-site; GBP 30,000 - 52,000; Full time

Job summary

IQVIA Biotech in the United Kingdom seeks an experienced Clinical Research Associate to perform on-site monitoring visits per GCP/ICH, with a focus on oncology studies.

You will drive recruitment planning with sites, administer protocol training, manage TMF/ISF, and collaborate with study teams to ensure data quality and regulatory compliance throughout the trial lifecycle.

Bachelor's degree in a scientific discipline or healthcare is preferred; 1 year of on-site monitoring experience is required.

Qualifications

• Minimum of 1 year of on-site monitoring experience.
• Experience monitoring Oncology studies is a must.
• Good knowledge of GCP/ICH guidelines and regulatory requirements.
• Strong written and verbal English communication skills.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out) per approved scope and regulatory requirements.
• Drive and track subject recruitment plans with sites to enhance predictability.
• Administer protocol and study training to sites and establish regular communication.
• Escalate quality issues and ensure investigator file maintenance per TMF requirements.
• Manage regulatory submissions, recruitment, CRF completion and data queries.
• Create and maintain site management documentation and visit reports.

Skills

On-site monitoring

Oncology studies experience

English proficiency

Regulatory knowledge

Communication skills

Time management

Financial management

Team collaboration

Problem solving

Education

Bachelor's Degree in scientific discipline or health care preferred

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Laptop/iPad usage

Job description

• 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) verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH 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.
• Minimum of 1 year of experience of on-site monitoring experience
• Experience monitoring Oncology studies is a must
• Bachelor's Degree in scientific discipline or health care preferred
• Equivalent combination of education, training and experience may be accepted in lieu of degree.
• Basic 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, 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.

Join IQVIA Biotech - Where Innovation Meets Impact

At IQVIA Biotech, we specialize in partnering with smaller biotech and emerging biopharma companies, creating a uniquely dynamic and fast-paced environment. Here, you won't just be part of the process-you'll be at the forefront of it. You'll gain early insights into groundbreaking therapies and novel diseases, often before they reach the broader scientific community. If you're passionate about innovation and eager to make a real difference in the world of biotech, this is your opportunity to thrive., 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.