Clinical Research Coordinator at SF Research Institute Fremont, CA
Behavioral Health Market Context
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Qualifications
- •B.A./B.S. degree (or equivalent combination of education and experience) in Health Sciences or related field
- •2+ years experience in coordinating clinical trials
- •Licensed Phlebotomist/Vaccination administration
- •Relevant experience across more than one phase of development, and across the entire lifecycle of a study
- •Excellent organization and attention to detail
- •Quick and eager learner
- •Ability to work independently
- •Strong critical thinking
- •Professional demeanor
- •Excellent oral and written communication
- •7 more items(s)
Responsibilities
- •As 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
- •Perform daily oversight and business management of all trials from start to study closure
- •Coordinating, 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 me
- •Preparing 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 documents
- •Serve as primary contact for sponsors regarding new studies, submission, IRB, IMVs, PSV and renewals
- •Perform oversight of clinical activities, NDA, FQ, site qualifications, and site initiation management
- •Manage trial feasibility process and oversee site capability assessments in collaboration with the sponsor team
- •Ensure trials follow in accordance with ICH/GCP standards and SFRI’s SOPs
- •Participate in review of clinical data to ensure readiness for QA and IRB regulatory audits
- •Assist regulatory staff with maintaining accurate information in all regulatory documents and study binders
- •Review clinical monitoring reports to ensure identification of site issues and implement corrective actions
- •Oversee and lead patient recruitment, advertising, screening, and enrollment, and data entries
- •Lead research staff to meet deadlines, and support quality and profitability
- •Track budgets and report expenses to contribute to budget forecasting
- •Oversee the drafting of site materials including training, manuals, and support documentation
- •Evaluate and provide revisions on protocols and clinical and regulatory documents
- •Lead weekly staff meetings related to BF, staffing, expenses
- •A/R, payable, study protocols clinic updates, and research activities
- •Conducts interviews, hiring, and reviews for study team
- •Ensure proper use and maintenance of all study equipment, inspections and calibrations
- •19 more items(s)
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