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Clinical Research Coordinator

External
alsglobal logoAlsglobal · Irving, TX
Full-timeOn-site3w ago
ComplianceDocumentation
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Health insuranceVision insuranceEquity / stock options

Additional Information

At ALS, we encourage you to dream big. When you join us, you'll be part of a global team harnessing the power of scientific testing and data-driven insights to build a healthier future. The Clinical Research Coordinator is responsible for the planning, coordination, and execution of clinical research studies, including the collection and management of clinical trial data. This role supports the conduct of safety and efficacy studies under the supervision of the Principal Investigator and in accordance with approved study protocols, company standard operating procedures, and current Good Clinical Practice guidelines. The incumbent performs all assigned responsibilities necessary to support compliant, accurate, and efficient study execution. Position Requirements/Essential Criteria: Bachelor's degree from a 4 year university Bachelor of Science or Arts degree in life sciences preferred. Certificates, licenses, and registrations preferred: Current certificate for: Human Protections, Good Clinical Practices, Bloodborne Pathogens Computer skills required 1 - 2 years' experience in clinical industry experience (substitute for BS or BA). Position Duties and Scope: The essential duties and responsibilities of this position include, but are not limited to, the following. Specific responsibilities may vary based on assigned site, study type, protocol requirements, testing methodology, instrumentation, and operational needs. Coordinate and support the planning, initiation, implementation, and day-to-day execution of clinical research studies in accordance with study protocols, sponsor requirements, company standard operating procedures, and current Good Clinical Practice guidelines. Prepare, organize, and maintain study materials and documentation, including informed consent forms, screening materials, medical history forms, source documents, study calendars, diaries, sign-in sheets, administrative notebooks, and other protocol-required records. Explain study procedures to research participants, obtain informed consent, and help ensure that subject eligibility and entrance criteria are confirmed in collaboration with the Recruitment Department and study team prior to study participation. Prepare study areas, patch booths, test materials, volatilized and non-volatilized patches, dilutions, and other supplies required for study conduct, and complete all applicable preparation, equipment, booth, cart, and study logs. Receive, log, weigh, prepare, fill, refill, rinse, and dispose of test articles and related materials in accordance with protocol requirements, safety procedures, and company guidelines. Conduct and coordinate daily clinical study activities to support efficient workflow, proper scheduling, and subject throughput while maintaining compliance with study requirements. Monitor research subjects' responses during study participation, assign and/or enter protocol-defined scoring, document observations, and accurately record adverse events and other study data in the appropriate study records. Operate study-related instruments and equipment during study conduct, ensure proper data collection and documentation, download and maintain study images and electronic files, and verify that instruments are properly shut down and stored after use. Prepare, update, and maintain study data tables, panelist or subject databases, logs, and other tracking tools to support accurate study oversight and reporting. Collaborate with investigators, project managers, clinical management, and other internal departments to communicate study progress, provide status updates, and support the preparation of protocols, interim reports, final reports, and sponsor deliverables. Perform front-desk, participant-facing, and general administrative support activities, including greeting study participants, recording participant attendance, and handling routine clerical functions such as copying, faxing, printing, filing, and document organization. Maintain study files and administrative records in an inspection-ready condition, including filing paperwork, archiving folders, and ensuring documentation is complete, current, and properly organized. Order, stock, restock, and maintain laboratory, clinic, and study supplies and materials necessary for ongoing research activities. Perform routine facility and study-area opening and closing procedures, which may include unlocking and securing entrances, disarming and setting alarms, turning lights and equipment on or off, preparing materials for the next study day, and ensuring work areas are clean, stocked, and ready for use. Conduct cleaning, disposal, and housekeeping tasks related to study execution, including product disposal, dilution disposal, disposal of used supplies, and maintenance of associated disposal records and logs. Provide support to senior clinical research staff and management and perform other related duties as assigned. Working at ALS The ALS team is a diverse and dedicated co


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