Clinical Research Coordinator 3 (Loma Linda)
Position Title: Clinical Research Coordinator 3Work Location: Loma Linda, CA, 92354Assignment Duration: 12 MonthsShift: Mon-Fri 8 am - 5 pmAdditional Skills/Qualifications: Prior oncology clinical trial experience, EDC experience, biospecimen handling and shipping experienceSummary:Perform a variety of clinical procedures to collect, record, report and interpret data on patients enrolled and/or seeking enrollment in clinical studies according to the protocol, standard operating procedures (SOPs), and Good Clinical Practice (GCP).Assist with daily workload planning.ResponsibilitiesProvide clinical research support to investigators to prepare for and execute assigned research studies, including:Review study protocols, Case Report Forms (CRFs), other study-specific documents, and electronic data capture systems used to record clinical research dataAttend all relevant study meetingsCollect and submit regulatory/ethics documentation as required by the FDA and other regulatory bodies governing the conduct of clinical researchRecruit and screen patients for clinical trials and maintain subject screening logsOrient research subjects to the study, including the purpose of the study, procedures, and protocol issues such as timelines for visitsDesign and maintain source documentation based on protocol requirementsSchedule and execute study visits and perform study proceduresCollect, record and maintain research subject study data according to study protocol and SOPs, preserving quality control for content, accuracy and completenessHandle lab testing and analysis, including preparation of specimen collection tubes and lab logisticsMonitor subject safety and report adverse reactions to appropriate medical personnelCorrespond with research subjects and troubleshoot study-related questions or issuesParticipate in "huddles" to confirm daily study tasks are assigned to team members and are executed to the expected standardsAssist with study data quality checking and query resolutionPerform a variety of complex clinical research procedures including but not limited to:ECGSample collectionSpirometryVital signsDose verificationCannulationCardiac telemetry monitoringRecord, report and interpret study findings appropriately to develop a study-specific database.Assist investigator in verifying that research study objectives are met on time, within budget and according to applicable protocol requirements, clinical research regulations and quality standards.Provide training to new investigator site staff members on study-specific topics and requirements.Assist in maintaining adherence to investigator site staff training requirements by auditing and maintaining training records.Prepare for and attend study monitoring visits, study audits, and regulatory inspections with clinical research regulatory agencies.Assist research site with coverage planning related to staffing and scheduling for research projects.Required Knowledge, Skills and AbilitiesKnowledge of clinical trialsIn-depth knowledge of departmental, protocol and study-specific operating procedures, consent forms, and study schedulesKnowledge of medical terminologySkilled in using MS Windows and Office applications such as:AccessOutlookExcelWordExcellent interpersonal skillsAbility to pay close attention to detailAbility to establish and maintain effective working relationships with coworkers, managers and clientsMinimum Required Education and ExperienceHigh school diploma (A BS would be a plus) or educational equivalent and relevant work experience in a clinical environment or medical setting; or equivalent combination of education, training and experienceApplicable certifications and licenses as required by the company, country, state, and/or other regulatory bodiesApplicant Notices & DisclaimersFor information on benefits, equal opportunity employment, and location-specific applicant notices, click hereAt SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position's starting pay is: $30.00/hr.