Clinical Research Coordinator
Behavioral Health Market Context
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Qualifications
- •Minimum 1-2 years of clinical research experience
- •Able to execute on research tasks with guidance from more experienced staff, PIs, and management
- •Strong written and verbal communication skils
- •Ability to read, interpret, and apply clinic policies and research protocols
- •Ability to use standard office software
- •Must be able to lift up to 25 pounds
- •3 more items(s)
Responsibilities
- •The CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study
- •Administratively and clinically manage industry‑sponsored clinical trials including problem solving, communication and protocol management
- •Lead patient recruitment activities, e.g., performing chart reviews, discussing protocols with patients, and verifying the informed consent documentation
- •Schedule all patient research visits and procedures consistent with protocol requirements
- •Conduct patient visits as outlined within each study protocol
- •Dispense study medication, collect vital signs and perform ECGs
- •Perform blood draws, process and ship specimens per study protocol and IATA regulations
- •Ensure relevant study and subject specific information is entered into the CTMS system on a regular basis; complete and maintain documentation study files including, but not limited to, consent forms, source documentation, progress notes if applicable, case report forms, and investigational accountability forms
- •Act as point of contact for study participants
- •Adhere to Research SOPs, Good Clinical Practices, and the study protocols
- •Maintain ongoing communication with the CRO, sponsor, research participants, Site Manager and PI throughout course of the study
- •Ensure all safety data is reviewed by the PI in a timely manner
- •Maintain inventory of study equipment and supplies onsite at all times
- •Participate actively in communication of status and results to management
- •Assist with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol
- •Schedule and prepare for monitor visits
- •Assists Study Team in protection of the rights and welfare of all human research participants involved in research in accordance with Federal regulations
- •Cooperates with site compliance and monitoring efforts regarding the access, use, and disclosure of PHI and reports instances of noncompliance
- •Complete and maintain case report forms per FDA guidelines, and review them against the patient’s medical record for completeness and accuracy
- •Iterative Health Expectations
- •Perform quality work within deadlines with or without direct supervision
- •Interact professionally with other employees, customers and suppliers
- •Work effectively as a team contributor on all assignments
- •Work independently while understanding the necessity for communicating and coordinating work efforts with other employees and organizations
- •21 more items(s)
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