Travel Nurse Level II RN - Clinical Coordinator, Research / Clinical ResearchHoag Memorial Hospital - Hoag Newport Beach • Newport Beach, CA, US
Travel Nurse Level II RN - Clinical Coordinator, Research / Clinical Research
Hoag Memorial Hospital - Hoag Newport Beach • Newport Beach, CA, US
[job_card.30_days_ago]
[job_preview.job_type]
- [job_card.full_time]
[job_card.job_description]
Job Description
- Basic Life Support (BLS) Certification
- Current Registered Nurse (RN) licensure in the State of California
- Responsible for all aspects of clinical research activities, working closely with study physicians, stakeholders, and sponsors.
- Manages complex clinical research trials including drug, device, and biologic studies across Phase I-IV clinical trials, government-funded research, and investigator-initiated studies.
- Ensures compliance with Good Clinical Practice standards, human subject protection regulations, and FDA guidelines.
- Provides overall study management, coordination, and operational support for assigned research trials.
- Performs protocol review and preparation prior to study initiation.
- Administers and manages the informed consent process according to regulatory requirements.
- Conducts subject recruitment, screening, and eligibility assessments.
- Collects, processes, and documents laboratory samples in compliance with International Air Transport Association standards.
- Ensures completion of all protocol-required clinical assessments and procedures.
- Accurately collects, records, and enters study data into clinical research databases while maintaining data integrity and quality.
- Completes case report forms and addresses data queries timely.
- Monitors and reports adverse events per protocol and regulatory requirements.
- Maintains regulatory binders and study documentation per sponsor and regulatory standards.
- Develops study flow sheets and prepares study source documentation.
- Hosts and participates in study team meetings and site initiation visits.
- Assists with cost analysis, study budget preparation, and tracking and distribution of study funds.
- Supports growth and strategic vision of the Hoag Institute for Research and Education.
- Assists with training and mentoring other Clinical Research Coordinators.
- Promotes team building and fosters a positive and respectful work environment.
- Two or more years of experience performing clinical research duties or equivalent experience and training.
- Knowledge of Good Clinical Practices, protection of human subjects, and FDA regulatory guidelines.
- Excellent verbal and written communication skills.
- Strong organizational skills with close attention to detail.
- Excellent interpersonal skills to work effectively within a diverse team environment.
- Strong analytical and problem-solving skills.
- Proficiency in Microsoft Word, PowerPoint, and Windows-based applications.
- Ability to work effectively in a fast-paced, team-based environment.
- Project management and coordination skills with ability to prioritize tasks and meet multiple deadlines.
- Ability to establish and maintain cooperative working relationships with patients, physicians, and coworkers.
- Ability to behave professionally and promote team-building behaviors.
- Ability to follow organizational and departmental policies and procedures.
- Ability to travel locally between organization locations as required.
- Current licensure in good standing as a Registered Nurse in the State of California.
- Preferred skills include working knowledge of FDA, NIH, and OHRP regulatory requirements.
- Preferred knowledge of ICH Good Clinical Practice guidelines.
- Understanding of clinical trial methodologies.
- Experience filing Institutional Review Board documentation.
- Ability to abstract data from medical records and transfer information into data collection forms or electronic databases.
- Preferred education: Bachelor of Science in Nursing (BSN) Degree or higher.
- Preferred certifications: Current ACRP Certification or SoCRA Certification, Nursing Specialty Certification, International Air Transport Association (IATA) Certification.
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