Clinical Research Coordinator

Clinical Research CoordinatorOverviewAs a Clinical Research Coordinator, you will lead the study team and be responsible for the execution of complex clinical trials from study design through study close out. You will be responsible for business and financial management of our research site, as well as oversight of day-to-day operations.ResponsibilitiesPerform daily oversight and business management of all trials from start to study closureCoordinating, monitoring, and supervising all aspects of clinical studies from start-up to closeout, to ensure proper execution of assigned clinical research trials and to ensure that study protocols are mePreparing and maintaining administrative logs and trackers, including Regulatory Documents Collection tracker, eTMF tracker, Health Canada submission tracker, Central IRB Submission tracker, Site Shipments tracker, study visits, etc.Package, label, process, and ship specimen, filing and tracking of study visits, survey documents, including monitoring reports and study source documentsServe as primary contact for sponsors regarding new studies, submission, IRB, IMVs, PSV and renewalsPerform oversight of clinical activities, NDA, FQ, site qualifications, and site initiation managementManage trial feasibility process and oversee site capability assessments in collaboration with the sponsor teamEnsure trials follow in accordance with ICHGCP standards and SFRI's SOPsParticipate in review of clinical data to ensure readiness for QA and IRB regulatory auditsAssist regulatory staff with maintaining accurate information in all regulatory documents and study bindersReview clinical monitoring reports to ensure identification of site issues and implement corrective actionsOversee and lead patient recruitment, advertising, screening, and enrollment, and data entriesLead research staff to meet deadlines, and support quality and profitabilityTrack budgets and report expenses to contribute to budget forecastingOversee the drafting of site materials including training, manuals, and support documentationEvaluate and provide revisions on protocols and clinical and regulatory documentsLead weekly staff meetings related to BF, staffing, expenses. AR, payable, study protocols clinic updates, and research activitiesConducts interviews, hiring, and reviews for study teamEnsure proper use and maintenance of all study equipment, inspections and calibrations.Education B.A.B.S. degree (or equivalent combination of education and experience) in Health Sciences or related fieldRequired Skills2+ years experience in coordinating clinical trialsLicensed PhlebotomistVaccination administrationRelevant experience across more than one phase of development, and across the entire lifecycle of a studyExcellent organization and attention to detailQuick and eager learnerAbility to work independentlyStrong critical thinkingProfessional demeanorExcellent oral and written communicationPreferred Skills3+ years of experience in related fields (MA, CNA, LPN)Experience in the Biopharmaceutical industry, Dermatology, Esthetics, Dietary Supplements or Ophthalmology, or Internal Med, Infection, Ob Gyn, Neurology, Cardiology or GI studiesExperience working with young patient groups and diverse communitiesThe position offers a minimum annual compensation of $80,000, with the potential for a higher salary based on the candidate's expertise and experience in clinical trials.

Created: 2025-02-21