Clinical Research Coordinator I

POSITION FUNCTIONThe Clinical Research Coordinator I (CRC I) performs a variety of administrative and clinical activities to assist the Investigators in conducting clinical studies. The CRC I will have a strong understanding of study protocols and will coordinate and manage study activities completely and accurately. Essential FunctionsProtocol and Safety: Ensure the safety and welfare of study participantsConduct the study as per protocol, GCP, and WPs/SOPs including screening study participants based on protocol inclusion/exclusion, scheduling visits, and obtaining study specific assessments e. g.

vitalsBe knowledgeable of study protocol to ensure all study activities are completed correctlyRecruiting, Screening, And Enrolling Study ParticipantsPromote and support study participant recruitment and enrollment initiativesEnsure proper written informed consent from each study participant prior to participation in the study and maintained during the studyStudy Visit CompletionPerform delegated research and administrative procedures to assist in conducting clinical studies under the direction of the InvestigatorPerform ECGs, vital signs, meal distribution, study participant monitoring, and other tasks as required by protocol/sitePerform phlebotomy, point of care testing, sample collection, processing & shipping as required by protocol/siteObtain all necessary documentation as required by the protocolTimely and accurate completion of source, data, CRFs, queries and CTMSSafety Reporting & Data IntegrityCollect and report all adverse events and abnormal results to the Investigator, Sponsor, and REB as per protocol and REB requirementsReport Serious Adverse Events and other expedited safety events within 24 hours to the Investigator, Sponsor, and REB and complete appropriate follow-up as requiredAccurately dispense investigational product and other study suppliesDocument receipt, storage, and maintain inventory of investigational product and other study suppliesCoordinate and prepare for monitoring visits and auditsPerform regular self and peer quality control (QC) checks and other QC tasks as deemed necessaryReview source documents and any other research documents required for the successful conduct of the clinical research studyMaintain and update all required documentation in the Investigator Site File, as requiredComplete periodic/annual study reports for REB, as requiredGeneralAbide by GCP, WPs/SOPs, company guidelines, and local healthcare privacy regulations Communicate study questions to the Investigators/Research Management/other CRPsCommunicate study updates and learnings with applicable staffMaintain professional relationships with study participants, physicians, industry representatives and vendors of trial managementSupport and maintain lab supplies, documents, equipment, as requiredProvide input on quarterly recruitment targets and support efforts to achieve site/company targetsAttend site, company, and sponsor meetings and study trainingsParticipate in on-call schedule, if requiredTimely phone and email communicationOrganize and participate in community and company outreach events as required (expectation 1-2 per calendar year)Archive study and study documents upon completion of a study Assist the Research Management and Investigators with any other research tasks as required