CRA 2, IQVIA Biotech

IQVIA Inc; Manchester; On-site; GBP 45,000 - 65,000; Full time

Job summary

IQVIA Biotech is seeking an on-site Monitoring professional to ensure high-quality conduct of oncology protocols and regulatory compliance across assigned sites. You will train and support site staff, manage recruitment plans, and coordinate with the study team to drive project success.

The role requires 1 year of CRA experience, strong knowledge of GCP/ICH guidelines, and excellent communication and organizational skills in English.

Qualifications

• Minimum 1 year 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 Good Clinical Practice (GCP) and ICH guidelines.
• Strong knowledge of protocols and therapy areas as provided in training.
• Proficiency in Word, Excel and PowerPoint; ability to use a laptop and mobile devices.
• Written and verbal communication skills in English.
• Organizational and problem-solving abilities.
• Effective time and financial management; ability to collaborate with study teams.

Responsibilities

• Perform site monitoring visits in compliance with GCP/ICH and contract scope.
• Work with sites to drive subject recruitment plans to enhance predictability.
• Administer protocol-related training to sites and maintain regular communication.
• Evaluate site practices for protocol conduct and regulatory adherence.
• Track regulatory submissions, recruitment, CRF completion and data queries.
• Ensure TMF and ISF documents are properly filed and up to date.
• Create and maintain documentation on site management, visits and actions.
• Collaborate with study team members for project execution support.
• May support start-up phase and per-site recruitment plans as applicable.
• May manage site finances according to trial agreements and invoicing rules.

Skills

On-site monitoring

GCP/ICH knowledge

Therapeutic/protocol knowledge

English communication

Organizational skills

Time management

Relationship building

Education

Bachelor's Degree in scientific discipline or health care

Tools

MS Office

Job description

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.

Responsibilities

• 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.

Qualifications

• 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.

This role is not eligible for UK visa sponsorship

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 https://jobs.iqvia.com

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.