Clinical Research Associate

Role Information

IQVIA is seeking a motivated and detail-oriented Clinical Research Associate (CRA) to join IQVIA’s Clinical Operations team. In this role, you will be responsible for monitoring clinical trial sites, ensuring the integrity of study data, and maintaining compliance with applicable regulatory requirements and sponsor protocols. You will serve as a primary liaison between IQVIA, clinical sites, and pharmaceutical sponsors — playing a critical role in accelerating safe and effective medical treatments to market.

This position offers the opportunity to work within a dynamic, sponsor-dedicated model that combines the stability of a global Contract Research Organization (CRO) with close collaboration alongside leading pharmaceutical partners.

Key Responsibilities

As a Clinical Research Associate at IQVIA, your day-to-day responsibilities will include:

1. Site Monitoring & Oversight:
   Conduct remote and on-site monitoring visits at investigational sites in accordance with the monitoring plan, ICH/GCP guidelines, and applicable local regulations. Verify that clinical trials are conducted according to the approved protocol, informed consent forms, and regulatory requirements.
2. Data Integrity & Source Verification:
   Perform source document verification (SDV) and source data review (SDR) to ensure accuracy, completeness, and consistency of data entered into electronic data capture (EDC) systems. Identify and resolve data discrepancies in a timely manner.
3. Investigator Site Management:
   Build and maintain strong, collaborative relationships with site personnel, including Principal Investigators, coordinators, and pharmacists. Provide training, guidance, and support to ensure sites are inspection-ready throughout the study lifecycle.
4. Regulatory Compliance:
   Ensure investigational product accountability, storage, and handling are compliant with protocol and applicable regulations. Review and verify essential regulatory documents in the Trial Master File (TMF) for completeness and accuracy.
5. Issue Resolution & Escalation:
   Identify, document, and follow up on protocol deviations, adverse events (AEs), and serious adverse events (SAEs). Escalate critical findings to the appropriate project team members to ensure timely resolution.
6. Reporting:
   Prepare high-quality monitoring visit reports and follow-up letters in accordance with IQVIA and sponsor timelines and standards.

Qualifications & Requirements

Education

Bachelor’s degree (or equivalent) in life sciences, nursing, pharmacy, or a related healthcare discipline.

Experience

1. Minimum of 1–2 years of on-site clinical monitoring experience as a CRA.
2. Experience in therapeutic areas such as oncology, neurology, cardiovascular, or immunology preferred.
3. Familiarity with ICH/GCP guidelines and local regulatory requirements.
4. Hands-on experience with EDC systems (Medidata Rave, Veeva Vault, Oracle InForm, or similar).

Skills & Competencies

1. Strong attention to detail and commitment to data quality.
2. Excellent written and verbal communication skills.
3. Ability to manage multiple sites and competing priorities independently.
4. Proficient in Microsoft Office Suite (Word, Excel, Outlook).
5. Strong organizational and time management skills.
6. Willingness to travel up to 60–70% (domestic and/or international, depending on assignment).