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Monitor investigator sites using a risk-based approach, applying root cause analysis and problem-solving skills.

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Ensure data accuracy through SDR, SDV, and CRF review during monitoring activities.

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Assess investigational products through physical inventory and records review.

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Document observations in reports and letters using approved business writing standards.

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Escalate deficiencies to clinical management and follow through to resolution.

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Maintain regular contact with investigative sites between monitoring visits.

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Provide trial status updates to the Clinical Team Manager (CTM) and ensure study systems are updated.

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Participate in investigator meetings and identify potential investigators in collaboration with the client.

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Ensure trial close-out and retrieval of trial materials.

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Conduct on-site file reviews as per project specifications.

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Assist in preparing project publications/tools and perform additional tasks as assigned by CTM.

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Facilitate communication between investigative sites, the client, and the project team.

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Maintain administrative tasks such as expense reports and timesheets.