Covenant Health

Registered Nurse Coordinator, Cardiology Clinical Research

Full Time, 80 Hours Per Pay Period, Day Shift

Position Summary: 

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. In addition, the Clinical Research Nurse Coordinator assures compliance with protocol and regulatory requirements, manages patient protocol activities, assures patient safety, collects records and maintains data and source documentation. The Clinical Research Nurse Coordinator performs all the duties and responsibilities associated with 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.

Recruiter: Sandra Simmons  || ssimmon6@covhlth.com || 865-374-5368

• Participates in protocol planning by applying knowledge of patient population and anticipated recruitment, considering the ability to maintain the rights, safety, and well-being of the patient and serving as the liaison between the investigator and the 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 at the manager’s discretion and scheduling and coordinating pre-study site visits, initiation visits, and monitoring visits.
• Manages subject recruitment and enrollment by monitoring enrollment goals and modifying recruitment plan as necessary, maintaining patient screening/enrollment logs, reviewing information about the protocol including inclusion/exclusion criteria with investigator. Assuring that all screening, eligibility and enrollment procedures are performed according to protocol requirements by reviewing source documents in EMR. Attends multidisciplinary conferences to help physicians with questions re: eligible trials for patients presented at conference.
• Maintains federal guidelines for Informed Consent process by communicating information about the protocol, informed consent form and follow-up procedures with potential study patients, conducting interviews to assess the patient’s ability and willingness to follow and complete study procedures and visits, obtaining informed consent from the patient prior to any study-related procedures and documenting appropriately.
• Coordinates patient enrollment in clinical trial by following randomization procedures as per protocol, scheduling patient office visits, required screening assessments, ensuring appropriate specimen collection, batching and shipping per protocol and assessing participant compliance with the test article and follow-up visits.
• Manages clinical trials patient by scheduling all protocol required tests, physician and nurse assessment visits, monitoring patients’ response to protocol treatment, accompanying the physician for all protocol required visits at all offices, reporting all serious adverse effects to the appropriate agency and Covenant Health System IRB according to protocol guidelines, manages/resolves complex patient/physician/clinical trial issues without supervision.
• Ensures patient safety with ongoing patient education about cancer treatment and disease process. Performs skilled nursing assessment and promptly reports all findings to investigator and sponsor. Recognizes laboratory values and assessment findings which are outside of normal limits.
• Documents and maintains all study-related procedures, processes and events by obtaining and reviewing original source documents (e.g., office notes, scans, tests, procedure results), abstracting data to study forms and flowsheets, recording accurate and timely data into electronic or hard copy case report forms, documenting protocol deviations and exemptions, planning and designing new forms/source document tools to be used in protocol implementation and resolving data queries- amending case report forms as appropriate.
• Maintains investigational agent accountability with proper utilization of drug logs and patient diaries; ensuring protocol guidelines are adhered to by all pharmacy staff. Oversight of storage, and integration of clinical trial pharmacy protocol with Covenant Health site policy.
• Protects participant confidentiality by adhering to HIPAA regulations, protecting patient privacy at all times, securing safe storage of study-related documents, assuring appropriate disposal of PHI, securely storing all archived files.
• Communicates effectively with patients, research team, IRB, sponsor, and Clinical Trials Manager by providing protocol education to ancillary staff. Establishing a contact mechanism for participants regarding follow-up visits, new information and encouraging study participants to report study-related events to the research team immediately. Effective communication with investigator and sponsor representative to ensure protocol compliance. Punctually submitting reports, suggestions and concerns to manager.
• Participates in monitoring visits and audits by collecting source documents for sponsor/audit review, meeting with monitors/auditors during routine visits to discuss case report form completion, query resolution and other protocol-related issues, preparing for and participating in FDA inspections as needed.
• Plans and directs site operations by assisting with the review and development of standard operating procedures manual, revising/updating procedures based upon regulations and guidance documents. Participating in the orientation and training of new research staff/ancillary staff involved in administering protocol treatments. Supervising Clinical Research Associates.
• Implements quality controls and assurance measures by monitoring compliance with study procedures and GCP standards, conducting quality assurance audits as requested, working with internal and external quality assurance teams.
• Maintains professional and technical knowledge by attending NCI Cooperative Group meetings (at least annually) at the discretion of the manager, presenting professional education to colleagues, reviewing professional publications and participating in professional societies. Completes all required IT training to access to various Electronic Data Capture systems and Electronic Medical Records. Proficient with basic office software such as Microsoft Office.
• Local travel required.
• Follows policies, procedures, and safety standards. Completes required education assignments annually. Works toward achieving goals and objectives, and participates in quality improvement initiatives as requested.
• Performs other duties as assigned.

Minimum Education: 

None specified; however must be sufficient to meet the standards for achievement of the below indicated license and/or certification as required by the issuing authority.

Minimum Experience:

Two (2) years experience in oncology nursing or two (2) years’ experience in clinical trials. Excellent written and oral communication skills, project management skills. Good Interpersonal and leadership skills. Excellent computer skills. 

Licensure Requirement: 

Must have and maintain Tennessee RN licensure. Employee must have a valid Tennessee driver’s license Class D and state mandated minimum insurance coverage. Driving record must meet Covenant Health minimum standards at the date of hire and throughout employment tenure.#cb