Clinical Research Coordinator-RN 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 Skills & Experience:

• Two (2) or more years of experience performing clinical research duties or equivalent experience and training.
• Excellent analytical and problem-solving skills.
• Excellent verbal and written communications and presentation skills; excellent organizational skills; close attention to detail and excellent interpersonal skills to work effectively in a diverse team.
• Ability to work effectively in a fast-paced, team-based environment; project management and coordination skills; ability to prioritize tasks and meet multiple deadlines on concurrent projects.
• Ability to establish cooperative working relationships with patients, co-workers, & physicians.
• Behaves in a professional manner in all settings and promotes team building.
• Follows policies set by the organization and department.

Working knowledge of FDA, NIH and OHRP regulatory requirements and ICH GCP guidelines.

• Understanding of clinical trial methodologies and experience filing Institutional Review Board documents.
• Ability to abstract data from medical records and transfer it to data collection forms or directly into databases.
• Proficiency with Microsoft Word, PowerPoint, and Windows.

Preferred Skills & Experience:

• N/A 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.