The position will help with clinical research in the department of Internal Medicine program to enhance health equity in Clinical trials along with some of the clinical duties as assigned by the Director of the Center of Excellence of Clinical and Translational Research and the Chair of the Internal Medicine. As an advanced practice medical professional, you will be responsible for ensuring the highest standards of patient care throughout the clinical trial process. Your primary role will involve conducting physical examinations, interpreting lab test results, and overseeing patients’ health while working closely with other healthcare professionals.
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:
