Registered Nurse (RN) - Clinical Research Coordinator II

Job Summary:

• The Clinical Research Coordinator-Registered Nurse II (CRC RN-II) is responsible for all aspects of clinical research activities and works in close cooperation with study physicians, inter- and intradepartmental stakeholders, and sponsors.
• The position is responsible for managing complex clinical research trials including drug, device, and biologic studies across Phase I, II, III, and IV clinical trials, government-funded research, and investigator-initiated studies while ensuring compliance with Good Clinical Practice standards, human subject protection regulations, and FDA guidelines.

Job Responsibilities:

• Manages complex clinical research trials including industry-sponsored, government-funded, and investigator-initiated studies.
• Maintains compliance with Good Clinical Practices, FDA regulations, and human subject protection standards.
• Provides overall study management, coordination, and operational support for assigned research trials.
• Performs protocol review and preparation activities prior to study initiation.
• Administers and manages the informed consent process in accordance with regulatory requirements.
• Conducts subject recruitment, screening, and eligibility assessments based on inclusion and exclusion criteria.
• 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 in a timely manner.
• Monitors and reports adverse events according to protocol and regulatory requirements.
• Maintains regulatory binders and study documentation in accordance with 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 the growth and strategic vision of the Client Institute for Research and Education.
• Assists with training and mentoring other Clinical Research Coordinators as needed.
• Promotes team building and fosters a positive and respectful work environment.
• Performs other duties as assigned.

Required Education:

• High School Diploma.

Preferred Education:

• Bachelor of Science in Nursing (BSN) Degree or higher.

Required Certifications & Licensure:

• Current licensure in good standing as a Registered Nurse in the State of California.
• Basic Life Support (BLS) Certification.

Preferred Certifications & Licensure:

• Current ACRP Certification. OR
• SoCRA Certification.
• Nursing Specialty Certification.
• International Air Transport Association (IATA) Certification.

Required Skills & Experience:

• Two (2) 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 the 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 in all work settings and promote team-building behaviors.
• Ability to follow organizational and departmental policies and procedures.
• Ability to travel locally between organization locations as required.

Preferred Skills & Experience:

• Working knowledge of FDA, NIH, and OHRP regulatory requirements.
• Working 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.