Senior CRA - IQVIA Biotech

IQVIA LLC; Broughton; On-site; GBP 40,000 - 56,000; Full time

Job summary

IQVIA Biotech is seeking an experienced Clinical Research Associate to perform on-site monitoring visits across oncology studies in the United Kingdom. You will ensure adherence to GCP/ICH, manage recruitment plans, and maintain high-quality TMF/ISF documentation.

Required are 3–4 years of on-site monitoring experience, strong communication and organizational skills, and proficiency with MS Word/Excel/PowerPoint.

Qualifications

• Minimum of 3-4 years of on-site monitoring experience.
• Experience monitoring Oncology studies is a must.
• Basic knowledge of GCP and ICH guidelines.
• Bachelor's Degree in scientific discipline or health care preferred.
• Equivalent combination of education, training and experience may be accepted in lieu of degree.
• Proficiency in Word, Excel and PowerPoint; use of laptop, iPhone and iPad where applicable.
• Written and verbal communication skills including good command of English.
• Organizational and problem-solving skills.
• Effective time and financial management skills.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in line with contract and regulatory requirements (GCP/ICH).
• Drive and track subject recruitment plans to enhance predictability.
• Administer protocol and study training to sites and maintain regular communication to manage expectations and issues.
• Evaluate site practices for protocol conduct and regulatory compliance; escalate issues as needed.
• Track regulatory submissions, recruitment, CRF completion and data queries; support startup when needed.
• Ensure site documents are filed in the Trial Master File and ISF maintained per regulatory requirements.
• Create and maintain documentation of site management, monitoring findings and action plans; submit reports and follow-up letters.
• Collaborate with study team for project execution; support development of recruitment plans per site; assist with site financial management where applicable.

Skills

Communication skills

Organizational skills

Problem-solving skills

Time management

Financial management

Interpersonal skills

Education

Bachelor's Degree in scientific discipline or health care

Equivalent combination of education, training and experience

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 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 3-4 years 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.
• 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.