CRA 2, IQVIA Biotech

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 wont just be part of the processyoull be at the forefront of it. Youll gain early insights into groundbreaking therapies and novel diseases often before they reach the broader scientific community.

If youre 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 Investigators 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
Bachelors 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