Research Nurse Coordinator

Job Description

About the Role

This position is responsible for ensuring adherence to all research programs and studies. Coordinates compliance implementation and conduct of human subjects research projects, carries out nursing responsibilities related to research. Assists with research study design and protocol development, as well as grant proposal writing.

Responsibilities

• Coordinates implementation and conduct of research projects to ensure adherence to protocol requirements including timely completion of documents, development of data capture and monitoring plans and reporting of Serious Adverse Events as they occur.
• Serves as primary liaison between investigators, research personnel and research administration office to assist in protocol interpretation, enrollment and safety questions.
• Utilizes the nursing process as a basis for patient care.
• Directs, coordinates and participates in the evaluation and supervision of nursing care provided to research subjects, establishing patient care priorities and delegating nursing activities according to patient needs and staff qualifications and capabilities.
• Assesses research subject, completes nursing assessment, documenting findings in research subject records, and notifies physician of abnormal findings.
• Establishes a care plan in collaboration with research subject, family and research team.
• Coordinates ongoing care.
• Identifies discharge needs and facilitates discharge planning as appropriate.
• Performs telephone triage.
• Performs nursing procedures and treatments as directed by physician in treatment or management of patient care.
• Administers medications and treatments as ordered by a physician.
• Evaluates, initiates and maintains standards of care consistent with CCAD policies and procedures.
• Assists with specialized patient care equipment as required by the clinical research protocol.
• Participates in education, research and performance improvement activities.
• Develops and maintains knowledge of research protocol to coordinate the comprehensive and compliant execution of assigned protocols.
• Assists with preparation for audits and response to audits.
• Maintains professional relationships, including frequent and effective communication with internal and external constituents.
• Assists with development of training and educational material for assigned research protocols.
• Provides and documents education as needed.
• Conducts and documents informed consent process.
• Assists PI with research study design and development of research protocol.
• May assist with research project budget development and grant proposal writing.
• Performs other duties as assigned.
• Coordinates preparation and maintenance of regulatory and ethics submissions, including initial submissions, amendments, continuing reviews, safety reporting, and study close-out documentation.
• Maintains accurate, complete, and inspection-ready regulatory binders and essential study documentation in accordance with institutional policies and ICH-GCP requirements.
• Supports sponsor, CRO, IRB/REC, and regulatory authority monitoring visits, audits, and inspections.
• Tracks protocol deviations, safety events, training compliance, and delegation documentation to ensure ongoing regulatory compliance.
• Ensures research activities are conducted in accordance with applicable regulatory requirements, institutional policies, human subject protection standards, and Good Clinical Practice (GCP).
• Assists with maintenance of study documentation and reporting within applicable institutional and regulatory systems.

Qualifications

• Education: Bachelor’s Degree or equivalent home country licensed.
• Proof of Basic Life Support (BLS) must be presented upon hire.
• Nursing degree.
• Knowledge of ICH-GCP, human subject protection principles, and applicable research regulatory requirements.
• Experience supporting regulatory submissions and clinical trial compliance activities preferred.

Required Skills

• Meets clinical competency requirements.
• Understands the design of healthcare documentation systems (i.e. Electronic Medical Record, Cardiovascular Hemodynamic systems, Registry Reporting Solutions, Business Intelligence, Event Reporting, Infection Prevention, etc.).
• Proficient in the use of PCs, spreadsheets and other software applications.
• Demonstrated ability in managing databases, developing reports and data analysis.
• Knowledge of The Joint Commission/The Joint Commission International, Health Regulators, Clinical Reporting Registries, or process and outcome measurement reporting requirements.
• Ability to express complex analytical and technical information to Executives or to Institute or Department leads.
• Strong oral and written communication skills.
• Minimum of 5 years of clinical experience.
• Clinical research experience.
• Certification and Licensure.
• Professional Membership.