Research Nurse - Heart and Vascular - Day/Evening

Full Time (80 Hours Biweekly)

Day/Evening Shift

Job Description

Under general supervision, coordinates clinical research activities and compliance to study requirements, and patient and staff considerations relative to specific clinical trials and/or studies. Monitors the clinical course and collection of research data for patients in clinical trials. Assists the medical investigators in achieving the objectives of clinical research studies, and supports ongoing patient management approaches in the designated disease/treatment area(s). Considers nursing implications in areas of staff and patient educational needs, staff resources, and research objectives. Acts as a resource for clinical and support staff involved in the care of patients enrolled in appropriate studies. Coordinates and performs nursing responsibilities in specialty area(s) for clinical research patients.

Duties and Responsibilities

Essential Accountabilities:

1. Participates in the review of research protocols and assesses the appropriateness, feasibility and resource requirements for implementation. Develops plans as needed to address patient care and staffing requirements.
2. Assists investigators in evaluating the quality of care and compliance to protocol requirements. Initiates corrective action
3. as needed. Ensures that there is documented Institutional Review Board approval for protocols and consent forms prior
4. to patient enrollment.
5. Maintains an excellent working knowledge of all protocols. Develops and conducts formal and informal education to
6. inform clinical and other staff of implications of protocol procedures. Distributes protocol and patient information in a
7. timely manner.
8. Ensures that patient pretreatment, eligibility and informed consent documentation requirements are met prior to patient
9. enrollment/registration in a research study. Registers and accomplishes randomization of patients enrolled in research
10. studies. Documents record of institutional patient registration.
11. Collaborates with nursing staff in assessing, planning, implementing and evaluating the nursing care of the patient
12. population specific to clinical research studies. Monitors dosage modifications and treatment calculations and assesses
13. patients for toxicity and response.
14. Evaluates and identifies potentially eligible protocol patients, and verifies according to protocol requirements. Provides
15. direct patient education regarding protocol participation, and provides additional information as appropriate. Ensures the
16. integrity of the informed consent process and assists in obtaining informed consent from patients. Works with internal
17. and external registration and scheduling personnel as appropriate to facilitate study entry.
18. Coordinates, observes and/or records data for protocol therapy. Actively participates in assessing patients for toxicity and response using chart review and physical assessment skills and communication with physicians and nurses.
19. Adheres to all protocol requirements to ensure validity of clinical research patient data. Submits complete and accurate forms and materials to external agencies as required in accordance with protocol requirements.
20. Coordinates protocol-related patient activities to ensure protocol compliance and optimal patient scheduling. Designs and compiles forms and educational materials to aid physicians and staff in complying with protocol requirements including tests and follow up visits.
21. Monitors and facilitates necessary documentation in the conduct of clinical research studies. Regularly reviews protocol
22. study forms for accuracy and compliance to protocol standards. Performs consistency checks, edits for errors, and
23. monitors timeliness of data submission. Identifies system inadequacies and augments the system as necessary.
24. Prepares and/or processes adverse event reports on protocol patients and submits these to the principal investigator and appropriate agencies. Alerts investigators and appropriate personnel of communications received regarding adverse events or drug reaction reports.
25. Oversees the receipt, secure storage and dispensing of medications provided for protocol patients. Reviews investigational drug logs and inventories to assure that appropriate documentation is maintained and federal guidelines are met.
26. Coordinates all site visit audits. Gathers records and other necessary materials required for audits. Reviews records with all site visit teams and responds to audit reports in a timely manner.
27. Maintains cooperative relations with clinical research participants. Acts as a liaison between national cooperative groups, institutional investigators, staff and affiliate groups.
28. Triages patient calls, attending to or resolving problems and answering questions.
29. Suggests improved methods for accomplishing research goals.

NonEssential Accountabilities:

1. Attends meetings as required.
2. Performs other related duties as identified.

Common Expectations:

1. Is knowledgeable of and complies with institutional research policies, procedures and guidelines. With the oversight of the Director of Research/Human Subjects Protection Administrator, has knowledge of and complies with governmental regulations regarding responsible conduct of research, research ethics and integrity and protection of the safety and welfare of human subjects (i.e., DHHS, FDA and IRB research regulations, HIPAA privacy and research regulations and others as applicable, such as those governing specimen banks, genetic research, etc.). Instructs less experienced personnel and advises others to insure that research is conducted safely and in compliance with the above. Reports apparent or potential problems to the Director of Research/Human Subject Protection Administrator and the appropriate Service Line Leader.
2. Demonstrates knowledge of the principles of growth and development over the life span of the assigned patient
3. population. Assesses and interprets patient age specific data and provides appropriate, age specific treatment. Provides
4. direct patient care to assigned patient age group(s).
5. Provides outstanding service to all customers; fosters teamwork; and practices fiscal responsibility through improvement
6. and innovation.

Qualifications

• Notes:
  • Other combinations of formal education, training and experience may be considered.
• Minimum Experience:
  • 2 - 3 years
• Minimum Education:
  • Bachelor's Degree
• Minimum Field Of Expertise:
  • Nursing; medical research; clinical trials
• Preferred Education:
  • Master's Degree
• Required Certification:
  • Registration and current RN license in PA; CPR certification
• Preferred Certification:
  • Appropriate RN specialty certification; National certification, clinical research/trials
• Physical Demands:
  • Occasional prolonged standing/walking