This position provides and coordinates clinical care for research subjects. This position has a central role in assuring participant safety, ongoing maintenance of informed consent, integrity of protocol implementation, and accuracy of data collection, data recording and follow-up. This position also engages in study procedures including administration of investigational drugs, detailed clinical assessments including adverse event assessments, and performing laboratory tests. Additional nursing care may be necessitated by the response of the participant to the study intervention. This position is responsible for study coordination and data management, with a central focus on managing subject recruitment and enrollment, consistency of study implementation, data management and integrity, and compliance with regulatory and institutional requirements and reporting. This position will support the Principal Investigator and Research team for departmental studies under minimal supervision.
- Family-Centered care that focuses on the need of the child first and values the family as an important member of the care team
- Excellence in clinical care, service and communication
- Collaborative within our institution and with others who share our mission and goals
- Leadership that set the standard for pediatric health care today and innovations of the future
- Accountability to our patients, community and each other for providing the best in the most cost-effective way.
Provides nursing care to research study patients, including:
- Performs and/or schedules medical tests within the scope of nursing licensure including, but not limited to, laboratory tests, vital sign readings, imaging studies, cardiac and/or pulmonary function tests, and psychological evaluations.
- Administers study medications and performs patient assessments during clinic visits to determine presence of side effects to medication; notifies principle investigator and responds to findings/issues.
- Provides patient education and medical information to study patients and their families to ensure understanding of proper medication dosage, administration and disease treatment.
- Documents medical data in patient chart to ensure availability of timely records for decision making.
Ensures assigned studies are conducted in accordance with the Food and Drug Administration (FDA), Office for Human Research Protections (OHRP), and Good Clinical Practices (GCP) guidelines, including:
- Reviews all regulatory requirements to ensure implementation of appropriate methods, practices, and procedures for all research activities in designated area.
- Responsible for the completion and submission of documents to the appropriate IRB and institutional committees on an ongoing basis.
- Maintains compliance with current and accurate documentation in the regulatory binders as required by regulations and sponsors.
- With the principal investigator, explains the study purpose, parameters, and requirements of the studies to the participants.
- Coordinates research subject informed consent and entry into appropriate research studies ensuring that all inclusion and exclusion criteria are met.
Coordinates the process for opening new studies.
- Obtains needed background material(s) on proposed research projects; presents findings and information to attending physician/principle investigator.
- Completes feasibility questionnaires.
- Circulates the confidentiality disclosure and trial agreements to the appropriate parties.
- Creates study budgets and works with management to determine financial feasibility and resources necessary to conduct the trial.
- Develops work flow procedures for study team based on specific protocol.
Completes all tasks required by study sponsors.
- Provides regulatory documents to sponsor in timely manner.
- Completes case report forms, data entry, and maintains source documentation for all study participants.
- Tracks and reports adverse events per sponsor and institutional guidelines.
- Coordinates research monitor visits and responds to all data queries.
- Participates in recruitment and selection of study participants. Coordinates and participates in research subject informed consent and entry into appropriate research studies ensuring that all inclusion and exclusion criteria are met.
- Reviews monthly financial reports, including study participant billing, expenditures, and revenue. Maintains inventory level of all supplies and equipment, initiates requisitions for replacement items, and maintains equipment to provide for continuous operational efficiency.
- Participates in a variety of professional development programs to ensure ongoing awareness and understanding of most current methodologies, practices, and philosophies as applied to the relevant patient population and research area.
- Performs miscellaneous job related duties as requested.