Clinical Research Nurse Manager
MedStar Health Research Institute - Baltimore, MD

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The HANDLS Clinical Nurse Manager will be responsible for the daily activities of the HANDLS staff on and off the Motorized Research Vehicles (MRV’s). Responsible for education of the staff: technical skills, orientation, staff development, resources and direct patient care. Develop, obtain approval for, and implement plans for structuring clinical unit to achieve optimal performance.

The HANDLS Clinical Nurse Manager will participate in the HANDLS research studies as the nurse practitioner. The nurse practitioner is responsible for screening, conducting history and physicals, follow up assessments and interventions for HANDLS research participants. This position will function independently and in collaboration with NIA Physicians and PIs.

Principal Duties and Responsibilities :

1. Communicate effectively with the MHRI staff members and the NIA staff to accomplish the mission of the HANDLS research group.

2. Oversee the activities on the MRV’s. Provide direct supervision and coordinate the activities on the nursing staff.

3. Ensure staffing patterns are adequate for patient safety and the requirements of the protocol. Review staff scheduling and participant daily schedules.

4. Play a role in staff acquisition as follows: Identification of staffing needs, preparation or revision of required paperwork (Position descriptions, requisitions, advertisements), review applicant documentation, conduct interviews, select candidates for offers to be made by MHRI HR. Provide formal documented orientation, competency and cross training programs.

5. Verify and validate time and attendance records for the staff.

6. Responsible for coordinating associate human resource needs with MHRI Program Manager. Administer all associate personnel actions for MHRI Clinical staff: i.e. hiring, time and attendance, benefits, evaluations, promotions, counseling, and terminations.

7. Responsible for the preparation and presentation of initial, mid-year and annual performance evaluations for clinical and administrative staff members, and integrating information collected from MHRI supervisory personnel and NIA scientific researchers.

8. Monitor staff for Good Clinical Practices in keeping with local, state, and government regulations.

9. Create, initiate approval of, and revise policies, procedures, SOP’s, and competencies for HANDLS staff, operations, and clinical research programs. Create/approve forms to facilitate safe, effective nursing practices. Monitor staff compliance to all Standard Operating Procedures.

10. Assist in the implementation and management of the HANDLS program in response to requirements set by the NIA clinical program and protocols , i.e. participate in planning meetings, assist in coordinating the flow of operations, and perform inspections required by JCAHO, OSHA, and relevant agencies of the State of Maryland. Provide for and contribute to clinical activities i.e. , staff meetings, clinical group meetings, safety, equipment Quality Control and Preventative maintenance, Quality Assurance, risk management, environmental health services and professional development.

11. Regularly assess the educational needs of staff. Provide in-service training as needed. Provide for education of clinical staff re: new protocols, technical skills, orientation, staff development, resources and direct patient care.

12. Act as a resource for staff and provide current information to perform both technical and complex procedures. Maintain group communication.

13. Oversee non-physician staff credentialing, e.g. licenses, CPR, mandatory classes, continuing education and ongoing reviews. Notify staff when updates are required. Maintain all training records for mandatory classes, orientation, competency, and cross training.

14. Evaluate participant eligibility for entry into research studies according to study protocol. Obtain informed consent. Provide appropriate referral and follow-up. Maintain contact with participants, primary care provider and PI, regarding current health status and management under the study protocol, if needed.

15. Monitor participants’ compliance and adverse effects, assume on-call duties as necessary to answer participants questions and assure participants health and safety.

16. Abstract, document and review participants screening and follow-up results.

17. Maintain contact with the NIA Physician, NIA Clinical Study Manager and principal investigator regarding the status of the participant.

18. Perform all study measurements and procedures as indicated by protocol.

19. Maintain and dispense medication as dictated by physician orders or protocol.

20. Monitor documentation and clinical notes on participants; maintain security of study data and confidentiality of participants’ information.

21. Administer and review consent forms and medical release forms with participants, as needed.

22. Perform blood draws and processing, anthropometric measures, physical exams, DEXAs and EKGs in accordance with policy and study protocol.

23. Participate in quality assurance activities of the MRV laboratory.

24. Participate in protocol development for new projects.

25. Keep the MHRI Program Manager, NIA principle investigator and NIA Clinical Study Manager informed of the progress of protocols and any problems on the team.

26. At the medical discretion of a NIA physician, implement discharge plans prepared in consultation with multi-disciplinary team members.

27. Precept new personnel as needed under the direction of the MHRI Program Manager.

28. Enter clinical and research data into computer systems using established software. Review and approve participant report packets prior to distribution.

29. Assist in preparing or reviewing reference material with NIA clinical investigators for the development of NIA research publications. Review manuscripts and papers derived from protocols in which they were involved for content and errors.

30. 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.

31. Perform other duties as assigned.

Minimum Qualifications:

Education: Graduate of an accredited Nurse Practitioner Program

Masters in Nursing

Experience: Two (2) years experience in clinical setting (inpatient/outpatient) as Nurse Practitioner involved in research and at least 2 years of supervisory experience.

Recognized clinical competency with sensitivity to the psychological, social and medical needs of participants.

Experience in clinical trials, research and data collection.

State of Maryland HIV Training preferred.

Licensure: Current license as an RN and ANP in the State of Maryland.

Current BCLS and ACLS certification.

Special Qualifications:

Strong verbal, written and interpersonal skills. Attention to detail with excellent organizational skills, the ability to manage multiple tasks, effective communication skills, intermediate experience in Microsoft Word and Microsoft Excel. Must be willing to work evenings and weekends on a weekly and regular basis.

Working Conditions:

Clinical setting with may require the incumbent to work with or be in areas where biohazard materials are present.

Must be able to lift and carry 30 pounds.

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