Specialist, Clinical Research Associate

Overview

Serve as the primary site contact and site manager for assigned clinical research protocols and sites in a country. Ensure study conduct complies with ICH/GCP, country regulations, company policies and procedures, quality standards, and adverse event reporting requirements.

What you'll do

• Develop strong site relationships and ensure continuity of site relationships through all phases of the trial.
• Perform clinical study site management and monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
• Gain an in-depth understanding of the study protocol and related procedures.
• Coordinate and manage various tasks in collaboration with other sponsor roles to achieve Site Ready.
• Participate in and provide inputs on site selection and validation activities.
• Perform remote and on-site monitoring and oversight activities using various tools to ensure data generated at site are complete, accurate and unbiased and subjects’ rights, safety and well-being are protected.
• Conduct validation, initiation, monitoring and close-out visits, and record clear, comprehensive and accurate visit and non-visit contact reports appropriately and in a timely manner.
• Collect, review and monitor required regulatory documentation for study start-up, study maintenance and study close-out.
• Communicate with Investigators and site staff on protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
• Identify, assess and resolve site performance, quality or compliance problems and escalate per the defined CRA Escalation Pathway as appropriate.
• Work in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal, regional operations, HQ functional areas, vendors, IRB/IECs and Regulatory Authorities in support of assigned sites.
• Manage and maintain information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
• Contribute to CRA team knowledge by acting as a process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate or required.
• Support and/or lead audit/inspection activities as needed.
• Perform co-monitoring visits where appropriate.
• Contribute to identifying new potential sites and work closely with them to develop strong clinical research capabilities.

What you'll need

• Accountability.
• Adaptability.
• Adverse Event Reporting System.
• Business Activity Monitoring.
• Clinical Development.
• Clinical Reporting.
• Clinical Research.
• Clinical Research Methods.
• Clinical Site Management.
• Clinical Study Management.
• Clinical Trial Planning.
• Clinical Trials Monitoring.
• Data Analysis.
• Data Monitoring.
• Data Reporting.
• Document Management.
• Electronic Trial Master File.
• Good Clinical Data Management Practice (GCDMP).
• Good Clinical Practice (GCP).
• Meeting Facilitation.
• On Site Management.
• Protocol Adherence.
• Protocol Development.
• Protocol Review.

Details

• Location: Gurgaon, Haryana, India.
• Employee status: Regular.
• Flexible work arrangements: Not Applicable.
• Job posting end date: 10/14/2026; the posting is effective until 11:59:59 PM on the day before the listed end date.