Are you a passionate clinical research professional looking to advance your career in the dynamic field of clinical trials? IQVIA, a global leader in healthcare intelligence and clinical research, is hiring a Clinical Research Associate (CRA) for its Thane, Maharashtra location. This is a full-time position with an end date of 20th March 2025. If you have at least 1 year of on-site monitoring experience and a strong understanding of Good Clinical Practice (GCP) and ICH guidelines, this could be the perfect opportunity for you!
Job Description
As a Clinical Research Associate (CRA), you will play a pivotal role in ensuring that clinical trial sites adhere to study protocols, regulatory requirements, and sponsor guidelines. Your responsibilities will include:
Key Responsibilities:
- Conduct site monitoring visits (selection, initiation, monitoring, and close-out visits) in compliance with regulatory standards and study protocols.
- Collaborate with sites to develop and track subject recruitment plans to meet project goals.
- Provide protocol and study training to assigned sites and maintain regular communication to address project expectations and issues.
- Evaluate site practices to ensure compliance with GCP, ICH guidelines, and local regulations. Escalate quality issues as needed.
- Track study progress, including regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution.
- Ensure proper maintenance of the Trial Master File (TMF) and Investigator’s Site File (ISF) in accordance with regulatory requirements.
- Prepare and submit monitoring visit reports, follow-up letters, and other study-related documentation.
- Support site financial management, including invoice retrieval and budget tracking, as per the clinical trial agreement.
Qualifications
To be successful in this role, you will need:
- A Bachelor’s Degree in a scientific discipline or healthcare (preferred).
- At least 1 year of on-site monitoring experience in clinical research.
- Strong knowledge of GCP, ICH guidelines, and clinical research regulations.
- Proficiency in Microsoft Office (Word, Excel, PowerPoint) and familiarity with laptops, iPhones, and iPads.
- Excellent written and verbal communication skills in English.
- Strong organizational, problem-solving, and time management skills.
- Ability to build and maintain effective relationships with coworkers, managers, and clients.
