DHR Health - US:TX:Edinburg - Days

Summary:

FLSA STATUS: ☒ Exempt • Non-Exempt

POSITION SUMMARY:

The Clinical Research APRN will support all human subject clinical trials as a Co-Investigator. This support will entail provision of expert nursing consultation and trial oversight, execution of all clinically-relevant clinical trial activities and procedures with patient safety at the forefront. The Research APRN will facilitate fluid communication with external clinical trial sponsors and contract research organization representatives. The Research APRN will work closely with clinical research study coordinators and all clinical research staff to help expedite successful completion of all human subject clinical trials.

POSITION EDUCATION/ QUALIFICATIONS:
• Graduate of an accredited school for professional nursing MSN required. Successful completion of practitioner program.
• Registered Nurse (RN) and Texas Advanced Practice Registered Nurse license.
• Two (2) years' experience as nurse practitioner with acute care experience preferred
• Bilingual - English/Spanish.
• Completion of required Human Subject Research Protection Modules provided by the Collaborative Institutional Training Initiative (CITI) and all Good Clinical Practice (GCP) training requirements (Preferred)
• BLS required
• ACLS required within 6 months of hire date
• Excellent customer service skills with emphasis on cultural sensitivity
• Computer skills required with vast knowledge of Microsoft Office suite.
• Excellent written and verbal communication skills required.
• Understands concepts of human subject research and is able to participate in and coordinate research programs in compliance with all codes of federal regulations (45 CFR 46 | HHS.gov)

JOB KNOWLEDGE/EXPERIENCE:
• Promotes the facility mission, vision and values by effectively communicating them to others. Considers mission, vision and values in developing services, standards and practices
• Primarily responsible to assess, evaluate and treat patients on clinical trials as per clinical trial specificities under the supervision and collaboration of a physician investigator, by using advanced knowledge and skill to identify abnormal conditions, diagnose health problems, develop and implement treatment plans, evaluate patient outcomes, and collaborate with or refer to a physician in the medical practice for further care management.
• Collaborate with designated physician investigators and research team members (consisting of principal investigators, clinical research nurses, clinical research coordinators and clinical research assistants).
• Clinical responsibilities include conducting a history and physical exam, monitoring toxicities, assessing clinical responses and providing exemplary patient care while ensuring the protocol is conducted in a high quality manner. Monitoring toxicities, assessing clinical status and providing direct patient care while insuring the protocol is conducted in a high quality fashion.
• Clinical responsibilities include being available during protocol directed therapy (i.e. infusions, injections, etc) as indicated or necessary depending on the circumstance.
• Clinical responsibilities include management of phone calls/ messages from enrolled clinical trial patients, and working closely with the PI, MD, and nurses to deliver exceptional care.
• Work in collaboration with clinical trial unit managers with initiating study procedures for new Investigator Initiated Trials (IITs) and industry-sponsored clinical trials. Manage all aspects of Phase I - IV clinical trials.
• Participate in the conduct of audits by study sponsors, CROs, the FDA, and other groups.
• Develop and maintain ongoing communication with the clinical teams including, but not limited to: laboratory, radiology, and pharmacy.
• Screening patients for protocols and participating in the informed consent process and providing education for patients considering enrollment.
• Review clinical/laboratory data and adverse events, manage protocol-specific toxicities in collaboration with the principal investigator and research team.
• Handle any questions subjects may have regarding protocol specifics, investigational products, lab results, effects of therapies, medications, and symptom management within level of expertise and referring other questions to the PI or medical team in order to obtain guidance or assistance.
• If needed, collect, review, provide guidance, and report timely, valid, accurate study data within the timelines specified by the Clinical Trials Agreement. Coordination may also include: transporting specimens, submission of study documents to all applicable institutional committees (e.g., IRB) for initial approval, continuing reviews and for approval of any amendments.
• Represents the disease-site team when meeting with Medical Science Liaisons, current and future research collaborators, and prospective donors
• Performs complete, accurate history and physical assessment/examination as appropriate for patient setting/type of visit.
• Orders, performs and interprets diagnostic tests and accurately, communicates results to patient, completes all documentation, adhering to compliance standards for documentation, coding/billing and collaborative supervision. Reports abnormal findings to collaborative/supervising physician.
• Prescribes appropriate treatment, pharmacological agents and/or other non-pharmacological interventions. Completes simple and complex procedures independently. Reports adverse patient responses to collaborative/supervising physician.
• Provides direct patient and family education regarding patient medical condition/disease process, treatment methodologies, outcomes management, wellness and prognosis.
• In addition to the essential job elements and duties listed here, other duties may be assigned or assumed which are within the scope of the employee's skill, expertise and licensure or certification.

Responsibilities:

POSITION RESPONSIBILITIES:

• Participates in DHR Health Institute for Research and Development clinical trials
• Fosters collaboration and communication across the continuum of care for clinical trial patients
• Attends committee meetings in which clinical research study update is requested (as needed)
• Provides expert nursing consultation and practice oversight
• Participate in performance improvement
• Maintains professional provider relationship with all clinical trial participants
• Educates patient/ caregivers on disease specific education
• Coordinates follow up care with Primary Care Physician or specialists
• Identifies barriers and provides solutions to help increase clinical trial participation
• Coordinate access to clinical and community based resources as appropriate
• Collects research study data according to protocol
• Conduct assessments according to research protocols
• Ensures the adherence of controlled clinical trial protocols.
• Obtains human subject consents
• Involved in patient recruitment and retention activities.
• Ensure that all clinical aspects of studies are being carried out in accordance with state and federal regulation, guidelines and policies.
• Ensure appropriate transmission of clinical case data to the sponsor data management centers.
• Reviews case report queries and problems, and clarifies and/or obtains changes to data as appropriate.
• Maintains process and tracking system of protocol related paperwork.
• All other duties as assigned.

Other information:

LINES OF REPSONSIBILITIES:

(Chain-of-command)

1. Vice President of DHR Health Institute for Research and Development → 2. Chief Executive Officer

CUSTOMER SERVICE:

Provide excellent customer service to all DHR customers. All employees are required to attend the DHR C.A.R.E.S program which outlines the Customer Service Principals including: Commitment, Accountability, Respect, Excellence and Service.

AGE SPECIFIC:

Employees must be able to demonstrate the knowledge and skills necessary to provide care appropriate to the age of the patients served in his/her assigned unit. The individual must demonstrate knowledge of principles of growth and development over the life span and possess the ability to assess data reflective of the patient's status and interpret the appropriate information needed to identify each patient's requirement relative to his or her age.

I have read and reviewed my job description with my supervisor or designee and I understand the job I am expected to perform.

If applicable ____________ certification will be completed within _________ time frame of hire/transfer date.

Employee Signature: Date:

Transfer/Hire Date Effective: .