Job Description

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a CRA (Level II) based in India.

This role offers the opportunity to support clinical trials at the intersection of scientific rigor, patient safety, and data quality.

You’ll coordinate clinical monitoring and site management activities across assigned studies and investigative sites.

The position combines remote and on-site monitoring with close collaboration across clinical, client, and project teams.

You’ll apply risk-based monitoring, critical thinking, and root-cause analysis to identify and resolve site-level issues.

Your work will help ensure trials follow approved protocols, ICH-GCP standards, regulatory requirements, and applicable procedures.

You’ll also contribute to audit readiness, investigator relationships, study documentation, and ongoing process improvements.

The role involves significant travel and is suited to an experienced CRA who can work independently while contributing effectively to a global team.

Accountabilities

• Conduct remote and on-site monitoring visits using a risk-based monitoring approach, assessing protocol compliance, data quality, investigational product accountability, and site processes.
• Perform source data review, source data verification, CRF review, and essential document checks as required by study specifications.
• Identify site deficiencies and risks through critical thinking and root-cause analysis, recommend corrective and preventive actions, and follow issues through to resolution.
• Maintain regular communication with investigative sites between monitoring visits to support protocol adherence, timely data entry, and resolution of previously identified findings.
• Initiate clinical trial sites, support investigator identification and meetings, and contribute to site close-out activities and retrieval of trial materials.
• Ensure essential documents are complete and maintained in accordance with ICH-GCP and applicable regulatory requirements.
• Provide study status updates, progress reports, and accurate information in clinical trial management systems.
• Facilitate effective communication between investigative sites, project teams, and clients through written, verbal, and electronic communication.
• Respond to applicable company, client, regulatory, audit, and inspection requirements.
• Complete administrative activities, including expense reports and timesheets, accurately and on time.
• Contribute to project tools, publications, process improvements, and other initiatives that strengthen clinical trial delivery and team effectiveness.

How Jobgether works:

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

Why Apply Through Jobgether?

Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.

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