Nurse Practitioner, Clinical Research Coordinator

Essential Functions (Principal Duties and Job Responsibilities):

The NP/CRC II assists in the supervision, coordination and monitoring of work activities 

• Responsible for the development of program goals and objectives, including Standard Operating        Procedure (SOPs) documents and training for all assisted supervised staff.
• Assists in preparation of the annual operating budgets
• Recommends, evaluates and interprets personnel actions and policies
• Round on patients in outpatient dialysis centers and/or hospital settings on a designated schedule
• Manage hemodialysis and peritoneal dialysis plans per Kidney Dialysis Outcome Quality Indicators (KDOQI) guidelines.
• Conduct comprehensive physical assessments and medication reconciliations prior to dialysis treatments
• Diagnose and manage system-related complications of ESRD therapy, including anemia, hypertension, fluid and electrolyte imbalances, and bone disease
• Adjust dialysis prescriptions (e.g., blood flow rates, ultrafiltration goals, dialysate composition) based on patient labs and tolerance
• Order and interpret diagnostic tests, laboratory values (Kt/V, hemoglobin, potassium, etc.), and imaging
• Educate patients and their families regarding kidney disease progression, treatment options, dietary restrictions, and lifestyle modifications.
• Ensures compliance with all federal regulations surrounding the conduct of clinical and translational research    including fiscal matters.
• Trains and maintains supervised staff in good clinical practices (GCP)
• Responsible for the development and implementation of SOPs for the program including financial matters and   issues that are followed by all stakeholders 
• Compiles customized reports on research activity as needed
• Assist in reviewing, monitoring, and reporting on all studies
• Assists with preparing IRB submissions, protocol revisions, and renewals as needed, and maintain copies of all IRB communications delegated by the Principal Investigator.
• Assists the staff in the conduct of clinical research trials including screening, recruitment, participant care and entering data
• Participate in periodic management meetings to keep the Executive Director informed of problems and concerns
• Assist in the development of cost reduction for projects and targets in collaboration with the  Executive Director
• Provide qualified competent staff by tracking projected staffing needs against qualifications competencies of current staff to identify any deficiencies, will rectify the deficiencies to improve staffing levels
• Along with the Executive director, create an environment that encourages and supports self-development and learning for all staff through regular feedback.  Ensure that each staff member’s ability is assessed regularly
• Counsel employees with regard to disciplinary actions taken in response to violations of institutional policies, including federal policies or contractual provisions and discuss such violations with the Executive director.
• Assist in interfacing directly with investigators to prepare presentations or reports of clinical study procedures, results, and conclusions.
• Perform physical examinations and assess patients’ medical histories in a clinical trial setting.
• Interpret and analyze lab test results to monitor patient health and make clinical decisions.
• Administer medications and oversee the safe administration of medications, ensuring adherence to clinical protocols.
• Conduct medical procedures such as venipuncture, IV-line placement, and other tasks as required by the study protocol.
• Monitor and provide safety observations during and after medication administration to ensure patient well-being and manage any adverse reactions.
• Collaborate with the primary investigator and other members of the clinical trial team to ensure the effective execution of study protocols.
• Contacts outside health care providers and communicate with subjects to obtain follow-up information.
• Directs the requisition, collection, labeling, storage, or shipment of specimens.
• Identifies protocol problems, informs investigators of problems, or assists in problem resolution efforts such as protocol revisions.
• Informs patients or caregivers about study aspects and outcomes to be expected.
• Schedules subjects for appointments and procedures as required by study protocols. Inform patients or caregivers about study aspects and outcomes to be expected.
• Instructs research staff in scientific and procedural aspects of studies including standards of care, informed consent procedures, or documentation procedures.
• Maintains contact with sponsors to schedule and coordinate site visits or to answer questions about issues such as incomplete data.
• Orders drugs or devices necessary for study completion.
• Organize space for study equipment and supplies.
• Reviews study-related documentation such as protocol worksheets, procedural manuals, adverse event   reports, institutional review board documents, and progress reports.
• Performs other related duties as assigned.

Knowledge, Skills and Abilities Required:

• Ability to manage a complex organization with direct reports

• Knowledge of business and management principles involved in strategic planning, resource allocation, leadership technique, production methods, and coordination of people and resources

• Experience in managing numerous direct reports

• Understanding and implementing the federal regulations that govern clinical research

• Ability to work with a variety of people to ensure their cooperation and input in documenting existing data and programs and in developing additional ones as needed.

• Ability to work closely with physicians, nurses and study coordinators

• Experience in initiating and coordinating collaborative and programmatic research across units or disciplines.
• Willing to complete the Clinical research professional training courses
• Ability to see patients and make clinical decisions with guidance.
• Evaluate patients with kidney disease or dialysis.

Knowledge, Skills, Abilities Preferred:

• Knowledge of Phase I-IV clinical trial operations.
• Knowledge of Institutional Review Board (IRB) processes and regulatory requirements.
• Knowledge of protocol implementation, source documentation, and clinical research compliance.
• Knowledge of Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC), REDCap, and electronic regulatory systems.

Education and Experience Required:

• Graduate of an accredited Advanced Practice Registered Nurse (APRN) program. Board Certification.
• Current, unrestricted licensure as an Advanced Practice Registered Nurse (APRN) in the State of Tennessee, or eligibility for Tennessee licensure prior to employment.
• One(1) to two (2) years of clinical experience as a Nurse Practitioner in Internal Medicine, Family Medicine, Primary Care, Pulmonary Medicine, Neurology, Infectious Disease, or another relevant specialty.
• Experience independently assessing, diagnosing, treating, and managing adult patients.
• Experience ordering and interpreting laboratory, imaging, and diagnostic studies.
• Experience prescribing medications and managing chronic and acute medical conditions.

Education and Experience Preferred:

• 1 – 2 years of prior clinical research experience or trials is preferred.
• Certified Clinical Research Professional (CCRP) – Society of Clinical Research Associates (SOCRA)
• Certified Clinical Research Coordinator (CCRC)
• Doctor of Nursing Practice (DNP)
• Experience serving as a Sub-Investigator or Clinical Research Nurse Practitioner on industry-sponsored or federally funded clinical trials.
• Experience in Phase II-IV pharmaceutical clinical trials.
• Experience managing participants with chronic diseases such as COPD, diabetes, hypertension, obesity, neurological disorders, infectious diseases, or cardiovascular disease.

Licensure, Certification or Registration Required:

• Nurse Practitioner with an active license in TN
• Nursing License (RN)
• APRN License 

Licensure, Certification or Registration Preferred:

• ACLS Certification