Under general direction of the Clinical Nurse Manager, this position is responsible for implementation and coordination of clinical research projects conducted at the NIA – research unit.
Principal Duties and Responsibilities :
1. Serve as a resource for clinical research protocols and related issues. Serve as co-investigator on research studies. Discuss protocol participation with subjects and others as indicated. Confer with physicians and staff regarding study issues.
2. Maintain knowledge of clinical trial requirements. Ensure that protocol requirements are clearly communicated to appropriate persons.
3. Identify and screen potential study subjects. Verify subject eligibility according to protocol specific criteria.
4. Effectively facilitate patient accrual to appropriate clinical trials, while ensuring adherence to human subject’s protection guidelines.
5. Coordinate the informed consent process.
6. Provide direct patient care to individuals who participate in research studies using the nursing process for provision of comprehensive health care in a research environment.
7. Work with the pharmacist to maintain adequate supply of study provided drug as applicable.
8. Design and maintain materials that aid in the accurate conduct of the study and in compliance with Good Clinical Practice and develop study specific and unit based Standards of Practice. Assist in writing and implementing staff competencies.
9. Participate in quality improvement and risk management processes.
10. Monitor the clinical course of study subjects and report side effects, disease status, and clinical adherence to protocols. Assist in the collection of data and provide in-service training to supporting clinical staff.
11. Provide patient/donor/participant education.
12. Serve as patient/donor/participant advocate.
13. Maintain required records of study activity including case report forms, on study cards, research files, adverse event reporting, and database records.
14. Maintain thorough source documentation as required by audit regulation.
15. Demonstrate good judgment to make decisions, adjust priorities, and manage schedule to ensure that work is accomplished within the required time frame and clinical needs of the unit are met.
16. Adhere to protocol specific and local requirements while accurately and completely submitting data and materials in a timely manner. Prepare regular reports of research activity. Present annual protocol updates.
17. Attend conferences as assigned, sharing information gained with pertinent staff. Prepare and present in-service education for staff.
18. Assist in the collection, preparation, and analysis of information for institutional special reviews and/or studies.
19. Regularly attends Clinical Investigator Meetings, committee meetings, and Staff Meetings.
20. Associate consistently demonstrates support for compliance in the performance of job duties and responsibilities by a) developing and maintaining knowledge of, and performing job functions in compliance with, rules, regulations, policies, and statutes that affect his/her job; b) maintaining knowledge of and performing job functions in compliance with MedStar Health and MedStar Health Research Institute policies and procedures; and c) reporting compliance concerns in an appropriate and timely manner.
21. Perform other duties as assigned.
Education: Bachelor’s degree in nursing and/or equivalent work experiences such that the objectives of the position are equaled.
Experience: Minimum of 6 months of clinical research work in the areas of recruitment, enrollment, monitoring and reporting data on clinical trial subjects. Three or more years experience in a healthcare setting.
Must possess organizational and prioritizing skills with the ability to manage multiple duties with close attention to detail. Must have the ability to understand and conceptualize technical information, demonstrating initiative, and communicating needs and requirements effectively.
Licensure: Current license as an RN the state of Maryland
Current BCLS certification
MedStar Health Research Institute - 20 months ago