Clinical Research Associate Jr Job
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Clinical Research Associate I
Acts as primary site contact and site manager for all operational and routine protocol issues in support of clinical research studies.
Communicates with sites on issues related to protocol conduct, enrollment / retention, protocol deviations, regulatory documentation, site audits / inspections, overall site performance, and financial payments.
Performs on-site monitoring visits, ensuring site compliance with protocol, ICH, GCP, Merck global standards, local laws and regulations, including but not limited to review of informed consent, AE / SAEs, Health Authority documentation, and IMP supplies.
Performs source document verification of subject data and query resolution.
Provides input to Site Selection utilizing site evaluation and validation processes.
Maintains accurate study site information in the CTMS and records visit and non-visit contacts appropriately and in a timely manner.
Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
Manages less than a full complement of sites with multiple protocols,depending on study / site complexity. Discusses the need for escalation of site performance issues with CRM.
2-4 years of Experience : 1-2 years clinical research preferred experience
B.A. / B.S. preferred with strong emphasis in science