01 Oct
|
Jobgether
|
India
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.
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Accountabilities
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Conduct remote and in office monitoring visits using a risk-based monitoring approach, assessing protocol compliance, data quality, investigational product accountability, and site processes.
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Perform source data review, source data verification, CRF review, and essential document checks as required by study specifications.
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Identify site deficiencies and risks through critical thinking and root-cause analysis, recommend corrective and preventive actions, and follow issues through to resolution.
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Maintain regular communication with investigative sites between monitoring visits to support protocol adherence, timely data entry, and resolution of previously identified findings.
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Initiate clinical trial sites, support investigator identification and meetings, and contribute to site close-out activities and retrieval of trial materials.
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Ensure essential documents are complete and maintained in
📌 CRA (Level II) (India)
🏢 Jobgether
📍 India