Clinical Research Coordinator-RN II

Company: Lancesoft INC
Location: Newport Beach
Posted on: February 18, 2026

Job Description:

Job Description Job Description Job Summary The Clinical Research Coordinator RN-II manages complex clinical research trials and works closely with physicians, sponsors, and internal teams to ensure studies are conducted safely, accurately, and in compliance with regulatory standards. This role supports drug, device, and biologic studies across Phase I–IV trials, including industry-sponsored, government-funded, and investigator-initiated research, while ensuring compliance with Good Clinical Practice (GCP), FDA regulations, and human subject protection guidelines. Key Responsibilities Manage complex clinical research studies from start to finish Ensure compliance with GCP, FDA regulations, and human subject protection standards Review study protocols and prepare for study initiation Coordinate study activities and provide operational support Administer and manage the informed consent process Recruit, screen, and assess study participants for eligibility Collect, process, and document laboratory samples (IATA compliant) Perform protocol-required clinical assessments and procedures Accurately collect, enter, and maintain research data Complete case report forms and resolve data queries Monitor and report adverse events per protocol requirements Maintain regulatory binders and study documentation Participate in site initiation visits and research meetings Assist with study budgets and financial tracking Mentor junior research staff and promote team collaboration Perform additional duties as assigned Qualifications Minimum 2 years of clinical research experience or equivalent training Knowledge of Good Clinical Practice (GCP), FDA regulations, and human subject protection standards Understanding of clinical trial methodology Experience with IRB submissions and regulatory documentation preferred Ability to abstract data from medical records and enter into research databases Strong communication, organizational, and problem-solving skills Ability to manage multiple projects and meet deadlines Proficiency in Microsoft Office applications Ability to work effectively in a fast-paced, team-based environment Active Registered Nurse (RN) license in the State of California (in good standing) Basic Life Support (BLS) Certification High School Diploma required; BSN or higher preferred ACRP or SoCRA certification preferred Nursing specialty certification and IATA certification preferred Ability to travel locally between sites as needed Company Description LanceSoft is rated as one of the largest staffing firms in the US by SIA. Our mission is to establish global cross-culture human connections that further the careers of our employees and strengthen the businesses of our clients. We are driven to use the power of our global network to connect businesses with the right people, and people with the right businesses without bias. We provide Global Workforce Solutions with a human touch. Company Description LanceSoft is rated as one of the largest staffing firms in the US by SIA. Our mission is to establish global cross-culture human connections that further the careers of our employees and strengthen the businesses of our clients. We are driven to use the power of our global network to connect businesses with the right people, and people with the right businesses without bias. We provide Global Workforce Solutions with a human touch.

Keywords: Lancesoft INC, Santa Ana , Clinical Research Coordinator-RN II, Science, Research & Development , Newport Beach, California