IQVIA · 1 month ago
Clinical Research Associate 2, Sponsor Dedicated, IQVIA
IQVIA is a leading global provider of clinical research services, and they are seeking a Clinical Research Associate 2 to perform monitoring and site management work for clinical studies. The role involves ensuring compliance with study protocols and regulations, managing site communications, and tracking study progress.
AnalyticsHealth CareLife Science
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
Qualification
Required
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
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
Benefits
Incentive plans
Bonuses
Health and welfare and/or other benefits
Company
IQVIA
IQVIA provides analytics, compliance, and management solutions to the life sciences industry.
H1B Sponsorship
IQVIA has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (134)
2024 (299)
2023 (263)
2022 (229)
2021 (208)
2020 (180)
Funding
Current Stage
Public CompanyTotal Funding
$3.5B2025-06-02Post Ipo Debt· $2B
2023-11-14Post Ipo Debt· $500M
2023-05-18Post Ipo Debt· $1B
Leadership Team
Recent News
Sabin Vaccine Institute
2025-12-04
Company data provided by crunchbase