Under the direction of the Biomedical Research Team Manager, the Clinical Research Nurse Manager supervises the clinical research nurses and works in association with other research staff in completing clinical and other research related duties according to specific study protocols and serves as lead coordinator for at least one study protocol.
1.Provides supervision and management of Clinical Research Nurses
- Provides administrative and operations supervision and training to the nursing team
- Work with department and team leadership to ensure nurses are well organized and productive.
- Assess and monitor efficiencies and productivity in nurse involved study visits
- Develops and coordinates orientation for new nursing staff to support knowledge transfer of research process and regulations.
- Provides ongoing assessment of nursing staff training needs throughout the course of the clinical research study and works with Study Clinician to make sure these needs are met in a timely manner.
- Coordinate and lead weekly meetings with the nursing staff and available study clinicians
2.Provides clinical care under established study protocols
- Assesses study participants’ state of health and being, including monitoring for adverse events of study procedures and products, to be reported to the study clinician, principle investigator, and/or study sponsors as required and as indicated using sound clinical judgement.
- Performs specified clinical procedures according to study protocols, which includes but is not limited to: phlebotomy, obtaining vital signs, administering injections, obtaining oral and genital cultures, obtaining urine/stool/tissue specimens, conducting detailed health histories, performing physical assessments, administering oral or intravenous medications, starting and maintaining peripheral intravenous lines, performing EKGs.
- Assesses, interprets and reports laboratory results; communicates and documents lab results to participant, other study clinicians and to primary care providers, as requested by participants, within the guidelines of informed consent and department policy
- Completes point-of-care laboratory testing
3.Performs study coordination duties as assigned
- Prepares Institutional Review Board submissions for responsible studies
- Develops study specific procedures (SSP’s) for use by all relevant personnel
- Prepare and deliver staff protocol training for responsible protocols
- Participate in study initiation and site monitoring visits. Works with PI and Biomedical Operations Director, Network Trials to respond to findings, implement quality improvement measures and train staff.
- Complete and maintain study specific regulatory documents according to guidelines of FDA, DAIDS, HHS, NIH, and/or study sponsor
- Develops protocol specific source documents and case report forms and leads staff training on protocol specific documentation procedures
- Collaborates with the recruitment team to ensure target goals are met for studies
- Monitors data metrics throughout study activity to ensure quality measures are being achieved
- Serves as a resource for teammates around adverse event and serious adverse event reporting
- Represents The Fenway Institute on all study-related conference calls and attends study specific operations meetings and trainings
- Actively participates in Quality Assurance activities that relate to the delivery of quality nursing/clinical care
- Coordinate study close-out activities, inclusive of database cleaning, confirmation of lock, file organization and storage, dissemination of study results to participants and stakeholders, as well as relevant communication to regulatory authorities and Sponsors.
- Maintains study product/medication accountability records and coordinates study product coordination with study pharmacists
4.Provides study specified health counseling and education
- Conducts pre- and post-test HIV counseling and education and risk reduction education per community, agency and study standards
- Conducts behavioral interviews with study participants in a clear, open-minded, non-judgmental context; maintains established guidelines of confidentiality and ethical accountability in all discourse with all study participants
- Conducts informed consent and/or provides study specific education during the informed consent process as needed
5.Provides care coordination and continuity
- Performs triage for study participants regarding adverse events and other medical issues and provides supported referrals as indicated
- Reports adverse events and health concerns or participants to clinician/investigator, study sponsor, and/or primary care provider as indicated within protocol specific time frames
- Coordinates with outside medical providers as needed to ensure care continuity
6.Accurately documents research data
- Completes and submits Case Report Forms accurately and in a timely manner
- Completes visit notes in a timely manner
- As needed, responds to data queries and meets with study monitors as indicated by the study sponsor within protocol specified time frames
- As needed, responds to laboratory data queries and performs regular laboratory quality control on all specimens stored for short term and long term storage
- Maintain study data in compliance with study sponsor/government agency standards
7.Supports staff to recruitment of study participants and assists with community engagement and education
- Works with the recruitment team
- Current licensure as a Registered Nurse in the Commonwealth of Massachusetts.
- Current BLS certification
- Bachelor’s degree in health-related field required, Bachelor of Science in Nursing preferred
- Minimum 1 year in a clinical setting; clinical research experience highly desirable
- Phlebotomy and IV placement experience highly desirable.
- Excellent health history and physical assessment skills
- Working knowledge of HIV pathophysiology, prevention, and treatment
- Familiarity working with individuals at risk for or living with HIV
- Ability to function autonomously in a collaborative team
- Experience working with an ethnically, culturally, and racially diverse work staff preferred
- Requires being able to work a 7.5 hour day, the majority of it sitting (>70%)
- Requires handling average-weight objects up to 15-20 pounds, assisting with patients’ standing and/or walking when necessary
- May work with blood or blood-borne pathogens
- Work environment involves exposure to potentially dangerous materials and situations that require following extensive safety precautions and may include the use of protective equipment
We offer competitive salaries, and for those who qualify, an excellent benefits package; including comprehensive medical and dental insurance plans, and a retirement plan with employer match. We also provide 11 paid holidays, paid vacation, and more.
LGBTQ-identified persons, people of color, and others from historically underrepresented communities are encouraged to apply.