Registered Nurse Coordinator, Cardiology Clinical Research

Full Time, 80 Hours Per Pay Period, Day Shift

Covenant Health Cancer Centers Overview: Covenant Health Cancer Center is our region’s largest cancer-fighting network, with more imaging centers, more board-certified physicians and surgeons, and more cancer and radiation centers closer to where you call home. We are a member of Covenant Health, our region’s top-performing healthcare network with 10 hospitals, outpatient and specialty services, and Covenant Medical Group, our area’s fastest-growing physician practice division. Therapies pioneered at Covenant Health Cancer Centers have transformed and saved the lives of hundreds of East Tennessee cancer patients, with progressive clinical trials bringing advanced new cancer medicines to the area. Facilities include the original downtown location and TCSC facilities in West Knoxville, Oak Ridge, Sevierville, and Morristown.

The Clinical Research Nurse Coordinator promotes good clinical practices in the conduct of oncology clinical trials by possessing in-depth knowledge of federal regulations and guiding documents for the conduct of clinical trials and human participant protection. The Coordinator ensures compliance with protocol and regulatory requirements, manages patient protocol activities, assures patient safety, collects records and maintains data and source documentation. Performs high-level, professional nursing practice including autonomous decision making based on predetermined protocol guidelines, nursing assessment and oncology knowledge. Reports to the Clinical Trials Manager.

Trial Planning and Strategy

Participates in protocol planning by applying knowledge of patient population and anticipated recruitment, considering patient rights, safety, and well-being, and serves as liaison between the investigator and sponsor to clarify expectations, goals, procedures, questions, and concerns.

Plans and implements pre-study activities by developing timelines for conducting the clinical trial protocol, attending and participating in investigator meetings, and scheduling pre-study site visits, initiation visits, monitoring visits, and close-out visits.

Manages subject recruitment and enrollment by monitoring enrollment goals and modifying the recruitment plan as necessary, maintaining patient screening/enrollment logs, reviewing protocol information (inclusion/exclusion criteria) with the investigator, and ensuring procedures are performed per protocol by reviewing source documents in the EMR. Coordinates patient enrollment by following randomization procedures, scheduling visits, required screenings, ensuring appropriate specimen collection, batching and shipping per protocol, and assessing participant compliance with the test article and follow-up visits.

Manages clinical trial patients by scheduling protocol-required tests and visits, monitoring response to protocol treatment, accompanying the physician for visits, reporting serious adverse effects to the appropriate agency and Covenant Health IRB per protocol guidelines, and resolving complex issues without supervision.

Regulatory Compliance and Safety

Maintains informed consent processes per federal guidelines by communicating protocol information and ensuring consent is obtained and documented appropriately.

Educates patients about cardiovascular treatments and disease processes, performs skilled nursing assessments, reports findings to the investigator and study sponsor, and recognizes abnormal laboratory values.

Documents and maintains study procedures and events by reviewing original source documents, abstracting data to forms, entering data into case report forms, documenting deviations, and designing new data tools as needed. Resolve data queries and amend forms as appropriate.

Maintain investigational agents/devices provided by the sponsor, accounting for products, and oversee storage and integration of clinical trial product according to Covenant Health policy.

Protect participant confidentiality by adhering to HIPAA, securing study documents, and disposing of PHI appropriately.

Communicate effectively with patients, the research team, IRB, study sponsor, and Clinical Trials Manager; Quality Assurance

Participate in monitoring visits and audits by collecting source documents and addressing case report form completion and queries; Assist with SOP development and staff training; supervise clinical research associates as needed.

Implement quality controls and QA measures; Local travel between Covenant Health facilities as needed.

Maintain professional knowledge by attending conferences, self-study, and IT training to access EDC/EMR; proficiency with Microsoft Office.

Follow policies and safety standards; participate in quality improvement initiatives as requested.

Minimum Experience: Two (2) years of experience in cardiology nursing/relevant nursing care or two (2) years’ experience in clinical trials. Excellent written and oral communication skills, project management skills. Excellent computer skills.

Licensure Requirement: Must have and maintain Tennessee RN licensure. Driving record must meet Covenant Health minimum standards at the date of hire and throughout employment tenure. #J-18808-Ljbffr Covenant Health