Nurse Practitioner, Men's Health, Aging, Metabolism

FULL TIME 40 HOURS/ RESEARCH Nurse Practitioner, M.S. / Men's Health, Aging and Metabolism

JOB SUMMARY

The Nurse Practitioner (NP) in the Department of Men's Health, Aging and Metabolism Research functions independently, strategizing primarily with the Principal Investigator (with a dotted line to Departmental Administrator), and is responsible for all aspects of project direction and administration. The NP is involved in all clinical trial activities and operations working collaboratively in an interdisciplinary team including clinical research assistants.

I. Clinical Trials Activities:

1. Lead complex clinical research studies.
2. Schedule and conduct study visits in the Men's Health Clinical Research unit. Coordinate study procedures to be conducted outside the unit at the Laboratory of Exercise Physiology and Physical Performance and at other institutional research locations.
3. Administer consent to study subjects following Good Clinical Practice (GCP) guidelines.
4. Monitor and report the occurrence of adverse events as dictated by the guidelines of the sponsor and governing IRB.
5. Prepare for and facilitate monitoring visits and quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups. Assist in developing corrective action plans when required. Respond to queries, if any, in a timely manner.
6. Review electronic medical records to pre-screen patients for study eligibility.
7. Collect vital signs, anthropometric data, and performs EKGs.
8. Prepare summary reports for Principal Investigator regarding enrollment status and study progress.
9. Prepare and submit electronic IRB applications (initial submissions, continuing reviews, amendments, exceptions, etc.).
10. Develop study-specific documents based on study protocol, e.g., protocol summaries, informed consent forms, eligibility screening scripts, subject recruitment materials and Case Report Forms (CRFs).
11. Maintain study regulatory documents and ensure study compliance with all government, sponsor, and IRB requirements.
12. Assist in the design of the study database. Maintain study database and perform data entry on an ongoing basis.
13. Assure adherence to intended timelines and achievement of study goals.

II. All Men's Health Clinical Research Study Operations:

1. Oversees the day-to-day conduct of multiple ongoing clinical research trials in accordance with the individual protocols.
2. Coordinates new study start-up activities including assisting in the development of the study protocol and related documents.
3. Holds routine all-staff and study-specific project meetings.
4. Keeps Director informed of all study-related issues, solutions, and results.
5. Facilitates Federal Drug Administration (FDA) initial submissions, amendments, and annual progress reports.
6. Contributes to the revision of Standard Operating Procedures, guidelines, and departmental policies.
7. Keeps abreast of changes in regulatory and institutional policies and communicates changes to investigators and staff as appropriate.
8. Coordinates study-specific training for internal and external staff, as appropriate.
9. Ensures that recruitment methods adhere to all regulatory and ethical policies regarding the protection of human subjects.
10. Oversees preparation for internal and external monitoring visits and audits.

III. NP Function

1. Act as a resource for members of the section of Men's Health.
2. Nursing related liaison for staff questions and concerns on study subjects' health status.
3. Performs EKG, weight, height, phlebotomy (if needed), sample processing (if needed).
4. Administers study medications (including IV infusions).
5. Conducts safety monitoring and reporting of adverse events.
6. Implementation of research protocols.
7. Interaction with investigators and staff of collaborating research sites.
8. Interaction with regulatory bodies and maintenance of regulatory documents.
9. Maintain clear, concise, accurate and legible records.
10. Maintain confidentiality with regard to patient information and other sensitive information.
11. Conform to hospital standards of performance and conduct, including those pertaining to patient rights, so that the best possible customer service and patient care may be provided.
12. Follow established hospital infection control and safety procedures.
13. Develop and implement measures to improve efficiency in office operations.
14. Attend and participate in meetings and/or committees, as required.
15. Assist in developing and implementing quality control (QC) procedures and training of staff.
16. Performs other clinical research duties as needed by Section of Men's Health.

Education/Licensure/Certifications:

1. Master of Science in Nursing (MSN) (or) DNP (or) PhD Degree in Nursing required. Completion of a Master's or post Masters' degree in adult or family NP program accredited by the Commission on Collegiate Nursing Education (CCNE) or the National League for Nursing Accrediting Commission (NLNAC).
2. Current Adult/Geriatric or Family Nurse Practitioner Certification by an accredited APRN certifying body required.
3. Valid prescriptive authority from both MA DPH and Federal DEA required.
4. Current APRN License to practice in Massachusetts required.

Experience:

1. Minimum 1 year clinical experience as a Nurse Practitioner required.
2. Minimum 1 year Clinical Research experience required.
3. Clinical nursing or nurse practitioner experience caring for a men's health patient population strongly preferred.

Brigham and Women's Hospital is an Affirmative Action Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.