STAFF NURSE - CLINICAL RESEARCH - CARDIOLOGY

Entity: Aultman Hospital

Position Summary:

The Clinical Research Coordinator assumes a central, key role for all studies conducted under the auspices of the Aultman Hospital research program. Primary responsibilities include administrative, functional and professional responsibilities under the direction of the Principal Investigator. The Research Coordinator is the primary point of contact for sponsors and study participants. All assigned responsibilities and expectations require extensive analysis and knowledge of assigned study protocols.

Department Summary:

The Clinical Research Department supports a variety of sponsored research studies. The Clinical Research Coordinator is responsible for administering and managing clinical trials in accordance with protocol, Good Clinical Practice, and regulatory standards.

Job Qualifications:

• Graduate of an accredited school of nursing; BSN preferred.
• Current, active licensure as a Registered Nurse through the Ohio Board of Nursing.
• American Heart Association (AHA) training in Basic Life Support (BLS) utilizing Rescuscitation Quality Improvement (RQI) required
• Cardiac disease and/or research experience preferred.
• Certification not required but encouraged.
• Completes required training as assigned:
  • HIPAA training (annually)
  • Hazardous shipping training (every two years)
  • Ethics Training
  • Good Clinical Practice training (every three years)
  • Standard Operating Procedure review (as assigned)
• Must be able to work effectively in a fast-paced environment, work on multiple concurrent inter-related subprojects, and be able to prioritize competing projects and deadlines.

Job Skills:

• Proficient computer skills to complete tasks as required.
• Must be organized, able to effectively prioritize tasks and exhibit appropriate time management skills.
• Must be detail oriented while focusing on safe practices and quality care.
• Demonstrates effective communication.
• Effective appropriate and professional interactions with colleagues/physicians, patients and visitors.

Responsibilities & Expectations:

• Completes and documents protocol required training.
• Uses medical knowledge to independently perform screening assessments to identify potential research subjects through office and electronic medical records.
• Recruits potential subjects
• Serves as a liaison between the Investigator and potential study participants to address questions and relay information
• Conducts, performs and documents the informed consent process as delegated by the responsible Investigator
• Maintains screening and enrollment logs.
• Oversees protocol compliance
• Facilitates the scheduling of visits, ordering of tests and procedures according to the protocol design
• Independently contributes to the assessment, planning, implementation and evaluation of nursing care. Analyzes data to make nursing diagnosis.
• Performs study specified assessments and procedures based upon licensure, qualifications, education, training and experience.
• Critically evaluates and documents subject response to the protocol treatment. Alerts and guides Investigators on protocol adherence and directives for action and reporting (i.e. investigational product dose modifications, additional monitoring requirements, safety reporting)
• Recognizes and reports adverse events and protocol deviations.
• Consults with pharmacy for drug dosing, accountability, handling, and dispensing.
• Collects, processes and ships central laboratory samples.
• Collection, compilation, analysis and submission of clinical research data in a timely manner.
• Appropriately and timely addresses data queries.
• Prepares and submits reports to the IRB and sponsor.
• Ensures that research records are complete, organized, up to date, and properly stored in a designated secure location.
• Tracks study related visits and procedures using study management system.
• Participates in site initiation, interim and close-out monitoring visits.
• Keeps Director of Research Programs, Principal Investigator and Treating Investigator updated on progress and all study and site-specific regulatory events.
• Performs all assigned research tasks in compliance with local Standard Operating Procedures (SOP’s), local, state, and/or federal regulatory requirements.

Working Conditions:

• Expected to work 8 hours a day Monday-Friday, day shift in accordance with approved FTE. Flexibility in schedule may be required.
• Must be willing to work or cover off-shifts/weekends and holidays as necessary.
• Cross training to all areas in the department is required.
• Subject to frequent interruptions and changes in priority of duties throughout the day.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, disability, gender identity, sexual orientation or protected veteran status.

Hazardous Exposure Category: Select Category I, II or III and delete the other categories.

Category I – Includes tasks that involve exposure to blood, body fluids, or tissues.

All procedures or other job-related tasks that involve an inherent potential for spills or splashes of, or mucous membrane or skin contact with blood, body fluids or tissues are Category I tasks. Use of appropriate protective measures is required for every employee engaged in Category I tasks.

Department Specific Responsibilities & Expectations:

Physical Addendum: Please place one “X” in the appropriate box for the requirement.