Clinical Research Nurse, Pediatrics

Clinical Research Nurse

The Clinical/Research Nurse specialist works in a strategic role in the Maternal/Child HIV Program and as a Research Coordinator within the Section of Pediatric Infectious Diseases. In the role of clinical nurse, this position provides integration of clinical and educational service. The major responsibilities of this position will be maintaining a leadership role in the prenatal, pediatric HIV and research activities of the section of pediatric infectious diseases integrating clinical care, patient education and access to research protocols appropriate for the BMC population. This position will identify, follow and educate HIV positive women about the targeted programs for antenatal, intra-partum and post-partum care for both mothers and infants transitioning into the Pediatric Infectious Disease Clinic. This position will also be responsible for identifying eligible clinical study subjects, obtaining medical history, informed consent, phlebotomy and specimen processing. The position requires experience and expertise in reviewing potential research protocols, preparing and initiating clinical trials, and assuring that research activities are carried out consistent with good research practice.

Key Responsibilities Include:

• Provides direct patient care and education of HIV/AIDS and pregnancy. Assesses the patient, collects pertinent data, and prioritizes information to meet immediate needs of the patient and develops and appropriate care plan.
• Follows up with Maternal and Child HIV/AIDS Team Staff
• Contributes and actively participates Active in departmental quality assurance review and in monthly clinical patient review.
• Provides follow up care in person and via telephone when needed. Works with the pharmacy and the ID/AIDS team in obtaining medication orders, prescriptions, refills, and communication.
• Conducts initial assessment and intake obtaining social, medical, mental health, substance abuse and medication history.

• Works with the Pediatric ID Faculty to implement protocols, maintains protocol integrity, monitors participant's status assuring safety, and plays a significant role in the education of clinical staff and clinical trial participants.
• Assists with recruitment/retention of research subject participants and provides patient education regarding protocol participation and additional information to ensure understanding and adherence. Ensures the integrity of the informed consent process between physician and patient.
• Drafts study subject consent forms, data collection forms, budget worksheets and IRB applications as needed. Responsible for study coordination activities like screening patients for determination of eligibility, enrollment, scheduling of clinical procedures, and follow up visits.
• Completes and evaluates case report forms for assigned patients. Submits completed case report forms to protocol sponsor within the required timeline.
• Performs consistency checks, error edits, and monitors timeliness of data submission to sponsors. Performs all aspects of the clinical data collection, research progress, adverse events, informed consent, and the medical care and response to the study treatment.
• Responsible for maintaining the clinical research data base.
• Coordinates sponsor site visit audits. Compiles required records and other audit materials. Reviews research records with site visit teams and responds to audit reports in a timely manner.
• Ensures that the IRB and Pharmacy are appropriately involved in study protocols according to established BMC policies and procedures.
• Provides functional and technical supervision to Laboratory Assistant, Data Manager), providing direction, guidance, explanations and professional expertise, as needed. May assist Medical Director and Principal Investigator in providing feedback for performance evaluations.

• Consistently uses clear concise and effective communication written/oral and comply with departmental policies when sharing/documenting relevant patient care data.
• Collects pertinent data using appropriate assessment techniques
• Conforms to hospital standards and regulatory standards (e.g., FDA, Sponsor, OHRP, etc.) of performance and conduct, including those pertaining to patient rights, so that the best possible customer service and patient care may be provided. Utilizes hospital's Values as the basis for decision making and to facilitate the hospital's mission.
• Follows established hospital policies and procedures, including infection control and safety procedures.

Job Requirements:

• Graduate of an accredited nursing program. Bachelor of Science Degree in Nursing preferred.

Certificates, Licenses, Registrations Required:

• Massachusetts licensure as a registered nurse.
• Maintain R.N. staff competencies on an annual basis.
• Phlebotomy (in both pediatric and adult population)

Additional certifications a plus:

• LDMS certified preferred
• Bio-hazard shipping certification preferred
• Certification from accredited clinical research program preferred.

Experience:

• 3 - 5 years clinical experience required.
• 1-2 years research experience required.

Knowledge and Skills:

• Computer skills required, preferably with Word, Excel and Access.
• Ability to input and analyze data and generate reports.
• Strong interpersonal, patient communication and patient education skills.
• Ability to work productively across academic clinical departments.
• Position requires tact and diplomacy to successfully motivate and educate faculty, and advanced knowledge of research regulations and research compliance requirements, including Protection of Human Subjects.
• Cultural sensitivity and comfort with a wide range of social, racial and ethnic populations

Job Benefits:

• Competitive pay
• Tuition reimbursement and tuition remission programs
• Highly subsidized medical, dental, and vision insurance options
• Career Advancement/Professional Development: Access a wealth of ongoing training and development opportunities that will not only enhance your skills but also expand your knowledge base especially for individuals pursuing careers in medicine or biomedical research.
• Pioneering Research: Engage in groundbreaking research projects that are driving the forefront of biomedical science.