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Study start-up;
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IND/CTA maintenance;
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Collaborative interaction with regulatory authorities and IRBs;
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Investigator site selection and feasibility assessments;
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Regulatory document package design (site level);
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Contract and budget preparation, negotiation, and administration;
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Investigator meeting organization and site training;
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CRA resourcing, mentoring, and co-monitoring support;
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Monitoring report review;
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SAE reporting coordination;
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Coordination of site/ vendor/ client communications; and
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Managing client expectations for on-time and on-budget performance.
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