Registered Nurse Coordinator, Cardiology Clinical Research

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.

Responsibilities

Trial Planning and Strategy

• 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, monitoring visits, and close-out visits.

Trial Recruitment and Management

• Manages Subject Recruitment and Enrollment by monitoring enrollment goals and modifying the 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 the EMR. Attend multidisciplinary conferences/meetings to provide study-related information as needed to the physicians discussed during the conference/meeting.
• Coordinates patient enrollment in clinical trials 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 trial patient by scheduling all protocol-required tests, physician and nurse assessment visits, monitoring patient’s 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 IRB according to protocol guidelines, manages/resolves complex patient/physician/clinical trial issues without supervision.

Regulatory Compliance and Safety

• 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.
• Ensures patient safety with ongoing patient education about cardiovascular treatments and disease process. Perform skilled nursing assessments and promptly report all findings to the investigator and study sponsor. Recognize laboratory values and assessments outside of normal limits.
• Documents and maintains all study-related procedures, processes, and events by obtaining and reviewing original source documents, i.e., office notes, imaging reports, lab reports, procedure notes, etc.), abstracting data to study forms and flowsheets, recording accurate and timely data entry into electronic or hard-copy case report forms, documenting protocol deviations and exemptions, planning and designing new forms/source document tools to utilize in protocol implementation. Resolve data queries and amend case report forms as appropriate.

Resource Management

• Maintain investigational agents and/or devices provided by study sponsor by accurately accounting for products received onsite. This includes all supplies provided by the study sponsor. Oversee the storage and integration of clinical trial product according to Covenant Health policy.

Communication and Report

• Protect 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, study sponsor, and Clinical Trials Manager by providing protocol education to ancillary staff. Establishing a contact mechanism for participants regarding follow-up visits, new study information and instructing 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, making suggestions or raising concerns to the Clinical Trials Manager.

Quality Assurance

• Participants in monitoring visits and audits by collecting source documents for sponsor review, meeting with monitors during routine visits to discuss case report form completion, query resolution, and other protocol-related issues. Prepare and participate in all audit tasks and meetings as needed.
• Assists with reviewing and developing standard operating procedures for study-related tasks as needed. Participant in orienting and training new staff involved in study visits. Supervise clinical research associates as needed.
• Implement 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.
• Local travel required. Will be traveling between Covenant Health Facilities as needed to meet with physicians and patients.
• Maintains professional and technical knowledge by attending conferences at the discretion of the Clinical Trials Manager; presenting professional education to colleagues, performing self-directed study, reviewing professional publications and participating in professional societies. Completes all IT training to access various EDC systems and EMR. Be proficient with basic office software such as Microsoft Office.
• 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.

Qualifications

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 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. 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