Research Nurse Coordinator
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Key skills for this role
About the Role
Cleveland Clinic Abu Dhabi seeks a Research Nurse Coordinator to ensure adherence to research protocols and coordinate clinical trials. The role involves nursing care for research subjects, regulatory submissions, and liaison between investigators and research administration.
Key Skills for This Role
Responsibilities
- Coordinate implementation and conduct of research projects to ensure adherence to protocol requirements
- Serve as primary liaison between investigators, research personnel and research administration office
- Utilize the nursing process as a basis for patient care for research subjects
- Assess research subjects, document findings, and notify physician of abnormal findings
- Administer medications and treatments as ordered by a physician
- Assist with preparation for audits and response to audits
- Conduct and document informed consent process
- Assist PI with research study design and development of research protocol
- Coordinate preparation and maintenance of regulatory and ethics submissions
- Track protocol deviations, safety events, training compliance, and delegation documentation
Requirements
- Bachelor's Degree in Nursing or equivalent home country licensed
- Proof of Basic Life Support (BLS) upon hire
- Minimum 5 years of clinical experience
- Clinical research experience
- Knowledge of ICH GCP, human subject protection principles, and applicable research regulatory requirements
- Experience supporting regulatory submissions and clinical trial compliance activities preferred
- Proficient in PCs, spreadsheets, and other software applications
- Strong oral and written communication skills
Full Job Posting
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.
Primary Responsibilities
- 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.
Required Skills
- Minimum of 5 years of clinical experience.
- Clinical research experience.
- Knowledge of ICH GCP, human subject protection principles, and applicable research regulatory requirements.
- Experience supporting regulatory submissions and clinical trial compliance activities preferred.
- Certification and Licensure.
- Professional Membership.
- 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.
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