Clinical Research Coordinator- RN II

Benefits

Qualifications

• •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
• •High School Diploma
• •Required Certifications & Licensure:
• •Current licensure in good standing as a Registered Nurse in the State of California
• •Basic Life Support (BLS) Certification
• •SoCRA Certification
• •Nursing Specialty Certification
• •International Air Transport Association (IATA) Certification
• •Bachelor's (Required)
• •Clinical research: 2 years (Required)
• •RN (Required)
• •BLS Certification (Required)
• •Newport Beach, CA 92663 (Required)
• •22 more items(s)

Responsibilities

• •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
• •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 Hoag 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
• •18 more items(s)