Job Description
The Clinical Research Coordinator II RN (CRC-II RN) is responsible for planning, coordinating, evaluating, and performing the nursing care of participants and collecting data for assigned research projects. This role requires following study-specific protocol guidelines, communicating with Principal Investigators (PI), Sub-Investigators (Sub-I), Clinical Research Lead, and clinical research support staff. The CRC-II RN advocates for the patient while adhering to the conduct of industry-sponsored and investigator-initiated clinical trials in accordance with trial protocols, FDA regulations, and ICH/GCP guidelines.
ResponsibilitiesDeliver safe care and demonstrate regard for the dignity and respect of all participants.Maintain skills in clinical competencies including physical assessment, phlebotomy, and IV insertion.Practice the principles of Universal Precautions and understand HIPAA regulations.Maintain a clean, prepared clinical space, and perform set-up and turnover procedures in all clinical areas per SOPs.Participate in internal and/or external training programs to maintain licensure.Utilize positive interpersonal communication skills; communicate effectively with healthcare team members, patients, investigators, sponsors of research, and administration.Review all elements of the current institutional IRB approved informed consent document with study candidates and/or legal representatives.Manage multiple clinical trial protocols, coordinate execution and follow-up, utilize resources, and work independently.Perform accurate, legible, and timely documentation; manage records, study medication, and test articles confidentially and securely.Promote PI oversight by advising the PI, sub-investigators, Supervisor, and/or Clinical Operations Manager of deviations in conduct, patient status, and issues relevant to trial integrity and subject safety.Coordinate the work of support staff, laboratory technicians, and assistants to ensure efficient, timely, and high-quality results and adherence to research protocols.Essential SkillsClinical trial experienceData collectionNeurologyDose calculationsConsentingCollecting dataDosingDiabetes managementClinical researchGCP knowledgeEKG proficiencyRegistered NurseAdditional Skills & QualificationsAbility to perform clinical tasks including assisting physicians and CRN with minor procedures and other study requirements within scope of practice.Ability to acclimate and integrate into various clinical settings as needed per protocol.Demonstrated skills in clinical competencies including physical assessment, phlebotomy, IV insertion, and administration of investigational drugs.Associate degree in NursingMinimum 2 years of Clinical Research experienceCurrent, active State of Florida license as a Registered NurseBLS certificationWork Environment
Hospital setting fully onsite.
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