IQVIA is a leading global provider of clinical research services, and they are seeking Clinical Research Associates (CRA) at the 1 and 2 level. The role involves performing monitoring and site management work to ensure compliance with study protocols and applicable regulations while managing the progress of assigned studies.
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
Skills
- 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 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
- Bachelor's Degree in scientific discipline or health care preferred
- Equivalent combination of education, training and experience may be accepted in lieu of degree
- Some organizations require completion of CRA training program or prior monitoring experience
Benefits
- Incentive plans
- Bonuses
- Health and welfare and/or other benefits
Company Overview
IQVIA provides analytics, compliance, and management solutions to the life sciences industry. It was founded in 1982, and is headquartered in Danbury, Connecticut, USA, with a workforce of 10001+ employees. Its website is https://www.iqvia.com.Company H1B Sponsorship
IQVIA has a track record of offering H1B sponsorships, with 167 in 2025, 294 in 2024, 261 in 2023, 229 in 2022, 208 in 2021, 180 in 2020. Please note that this does not guarantee sponsorship for this specific role.
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