Works at a clinical research site under the direction of a principal investigator or sub- investigator and reports to the Clinical Manager of Medical Oncology. All activities are conducted under Good Clinical Practice (GCP) Guidelines.

NON-EXEMPT

Follows all protocols for site preparation for a study.

Checks eligibility requirements to confirm patient eligibility for protocol.

Completes data compilation in a timely manner.

Provides follow-up and maintenance.

Ensures informed consent and all pre-treatment and eligibility requirements of protocols have been met prior to registration.

Enrolls/Registers protocol patients with the appropriate sponsor or statistical office.

Documents record of institutional patient registrations as well as data assigned by sponsor or statistical offices.

Orders and maintains investigational agents as provided by the protocol.

Practices good guest relations with patients, visitors, physicians, principal investigators, sub-investigators, pharmaceutical representatives (monitors) and staff, assists as needed.

Operates equipment safely and correctly.

Demonstrates awareness of the responsibilities of the position and how it interfaces with the rest of the healthcare team.

Works closely with all department members as required, is flexible to meet the needs of the department and changes in the workload.

Demonstrates an ability to be flexible, organized and function under stressful situations.

Maintains a good working relationship both within the department and with other departments.

Consults with other departments as appropriate to collaborate in patient care and performance improvement activities.

Participates in risk management and safety activities.

Documentation meets current standards and policies.

Consistently demonstrates a professional, self directed, mature, disciplined and tactful approach to department responsibilities

Attends necessary educational events, including weekly tumor boards.

Files protocols, SAEs and other documents with appropriate IRB.

Other projects as assigned.

Demonstrates the ability to deal with pressure to meet deadlines, to be accurate, and to handle constantly changing situations.

Demonstrates the ability to deal with a variety of people, deal with stressful situations, and handle conflict.

Adheres to dress code.

Completes annual educational requirements.

Maintains regulatory requirements.

Wears identification while on duty.

Maintains confidentiality at all times.

Attends department staff meetings as required within the department.

Reports to work on time and as scheduled; completes work in designated time.

Represents the organization in a positive and professional manner.

Actively participates in performance improvement and continuous quality improvement (CQI) activities.

Coordinates efforts in meeting regulatory compliance, federal, state and local regulations and standards

Communicates and complies with the Benefis Health System Mission, Vision and Values as well as the focus statement of the department.

Complies with Benefis Health System Organization Policies and Procedures.

Complies with Health and Safety Standards and Guidelines.

RN Requirements:

Ability to perform head-to-toe assessments on all patients and reassessments in compliance with the clinical research protocol.

Demonstrate an ability to assist physicians, principal investigator and sub-investigators with protocol-related procedures.

Demonstate an ability to be flexible, organized, detail-oriented, and function under stressful situations.

Knowledge of medications and their correct administration utilizing the clinical research protocol.

Follows protocol guidelines to ensure/reduce the potential of medication errors.

Performs all aspects of patient care in an environment that optimizes patient safety and reduces the likelihood of medical/health care errors and are in compliance with clinical research protocol.

Ability to interpret the results of waived tests; takes appropriate action on waived test results.

Treats patients and their families with respect and dignity.

Communicates appropriately and clearly to physicians, principal investigator, sub-investigators and staff and all others.

Demonstrates an ability to be flexible, organized and function under stressful stituations.

Documentation meets current standards and policies, including those governed by the FDA's Good Clinical Practices (GCP).

Consults with other departments as appropriate to collaborate in patient care and performance improvement activities with regard to patients' participation in a clinical trial