IMCS Group · 13 hours ago
Clinical Research Coordinator-RN II
Newport Beach, CA
Full-time
Onsite
Entry, Mid Level
2+ years expIMCS Group is one of the fastest growing MWBE staffing firms in the U.S. They are seeking a Clinical Research Coordinator-Registered Nurse II responsible for managing complex clinical research trials and ensuring compliance with Good Clinical Practice standards. The role involves coordinating research activities, maintaining study documentation, and supporting the growth of the Institute for Research and Education.
Staffing & Recruiting
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 *** 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
Qualification
Required
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
Current licensure in good standing as a Registered Nurse in the State of California
Basic Life Support (BLS) Certification
Preferred
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
Bachelor of Science in Nursing (BSN) Degree or higher
Current ACRP Certification
SoCRA Certification
Nursing Specialty Certification
International Air Transport Association (IATA) Certification
Company
IMCS Group
IMCS Group is an IT, Healthcare, and Professional Staffing Company that helps Enterprises optimize the business value of their Staffing investments and enables them to achieve world-class business performance.
201-500 employees
H1B Sponsorship
IMCS Group has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (11)
2024 (16)
2023 (33)
2022 (32)
2021 (47)
2020 (82)
Funding
Current Stage
Growth StageLeadership Team
Satish G Kumar
Founder and CEO
Kathleen Thompson
Diretor Client Partnership
Company data provided by crunchbase