CRA 2 at IQVIA – in Thane, Apply Now!
Are you ready to take the next step in your clinical research career? IQVIA is hiring a Clinical Research Associate 2 (CRA 2) in Thāne, India. This full-time role offers hands-on experience in site monitoring, regulatory compliance, and trial execution, while contributing to global health solutions. Learn more about the exciting responsibilities and qualifications that can help you grow with a global leader in clinical development.
Job Overview for CRA 2:
Location: Thāne, India
Employment Type: Full-time
Job Code: R1469120
Job Description
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations, and guidelines, and sponsor requirements.
Essential Functions for CRA 2:
- 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) and verify that the Investigator’s Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
Qualifications for CRA 2:
- Bachelor’s Degree in a scientific discipline or health care preferred.
- Requires at least 1 year of on-site monitoring experience.
- Good knowledge of applicable clinical research regulatory requirements (GCP and ICH guidelines) and therapeutic and protocol knowledge.
- Computer skills including use of Microsoft Word, Excel, PowerPoint, and technology devices.
- Strong written and verbal communication, organizational, problem-solving, time management, and financial management skills.
Keywords: clinical research, site management, GCP, ICH guidelines, healthcare intelligence, patient outcomes, population health, Thane, India.
