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Job Requirements of Clinical Research Coordinator - RN II:
-
Employment Type:
Contractor
-
Location:
Newport Beach, CA (Onsite)
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Clinical Research Coordinator - RN II
Careers Integrated Resources Inc
Newport Beach, CA (Onsite)
Contractor
Job Title: Clinical Research Coordinator - RN II
Locations: Newport Beach, CA 92663
Duration: 3 Months+(Possible Extension)
Pay Rate: $70/hr. on W2
Job Summary:
Job Responsibilities:
Required Skills & Experience:
Preferred Skills & Experience:
Locations: Newport Beach, CA 92663
Duration: 3 Months+(Possible Extension)
Pay Rate: $70/hr. on W2
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 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.
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