Education / Licensure / Certification:
Graduate of an accredited school of nursing.
Certificate/License: Current state licensed practical nurse license and CPR certification. RN, LPN, CMA or CT program (Clinical technician)
One year of professional nursing experience in a clinical setting preferred.
Performs diverse administrative and clerical responsibilities requiring some analysis, judgment and knowledge of specific study protocols. Completes all case report forms and distributes study medication and instructions to patients – participants, under the direction of the investigator. Maintains accurate, confidential files and documentation of study participants.
MAJOR WORK ACTIVITIES:
1. Coordinates protocol studies assigned by Research Manager.
2. Obtains detailed knowledge of all components of study protocol through independent analysis and review of study prior to study effective date.
3. Reviews with supervisor any components of the study prior to initiation date for which the incumbent requires additional information or clarification.
4. Reviews basic study information and prepares synopsis of a protocol. Reviews synopsis with potential participating physician to gain their commitment to study. Use synopsis to provide IRB with appropriate information and update.
5. Screens patients to identify potential patient participants for a specific study.
6. Validates potential patient-participant data against pre-established inclusion criteria for various studies.
7. Demonstrates skill with high-risk procedures or non-routine procedures.
8. Provides CRA or sponsoring organization with requirements and information per audit visit.
9. Completes and maintains case forms per FDA guidelines; retains or forwards copies of forms as required by the sponsor.
10. Provides patient with written communication of their participation.
11. Informs referring doctor of patient’s participation in our studies and outcome of any adverse drug reactions.
12. Ensures that all laboratory tests are performed at the designated lab facility and follows procedure to ensure patient completion.
13. Assists with data collection for possible prospective and retrospective studies that may be arms or addendum of given protocols.
14. Scans all existing schedules in order to provide patient with convenient time for appointment.
15. Reviews schedule of patient diagnostic tests in hospital and office for potential patient participants in assigned studies.
16. Maintains information in a confidential manner, in accordance with State, Federal and Practice guidelines.
17. Performs other duties and responsibilities as assigned by supervisor.
KNOWLEDGE, SKILLS AND ABILITIES:
1. Knowledge of professional nursing theory and practice to give and evaluate patient care.
2. Knowledge of organizational policies, regulations and procedures to administer patient care.
3. Knowledge of medical equipment and instruments to administer patient care.
4. Knowledge of common safety hazards and precautions to establish a safe work environment.
5. Skill in applying and modifying the principles, methods, and techniques of professional clinical care to provide on-going patient care.
6. Skill in identifying problems and recommending solutions.
7. Skill in preparing and maintaining records, writing reports and responding to correspondence.
8. Skill in establishing and maintaining effective working relationships with patients, medical staff, and the public.
9. Ability to maintain quality control standards.
10. Skill in developing and maintaining department quality assurance.
11. Ability to react calmly and effectively in emergency situations.
12. Ability to interpret, adapt and apply guidelines and procedures.
13. Ability to communicate clearly.
14. Physical job demands may be subject to possible modifications to reasonably accommodate individuals with disabilities.
Cone Health (formerly Moses Cone Health System) serves patients in central North Carolina through five acute and specialty care hospitals...