Job Description & How to Apply Below
In close collaboration with the Principal Investigator and Director, Clinical Research Operations, incumbent will serve as a Registered Nurse on various clinical research studies and will ensure that the integrity and quality of clinical trials are maintained and conducted in accordance with federal, state, local, Institutional Review Board (IRB), and organizational regulations. This position is primarily responsible for the accurate planning, preparation, and completion of study activities including visit procedures and collection of information from study subjects according to protocols as well as protecting the health, safety, and welfare of study subjects in both a clinical research coordinator and nursing capacity.
Responsibilities
Work with the principal investigator or other co-investigator(s) on clinical research studiesAssure compliance with the protocol requirements as mandated by the sponsor, our Standard Operating Procedures (SOPs), local and/or central Institutional Review Boards (IRB), and the U.S. Food and Drug Administration (FDA)Providing nursing care to research study patients:Participates in recruitment and selection of study participants by interviewing and documenting medical history to determine eligibility requirements for each studyPerforms medical tests, including but not limited to vital signs, imaging studies, electrocardiograms, IV line insertion, and blood drawsAdministers investigational medications and performs patient assessments during clinic visits to determine presence of side effects and notifies Principal Investigator accordinglyProvide education and information to study patients to ensure understanding of proper medication dosage, administration, and disease treatmentDocuments medical and study data appropriately in patient charts/source documents to capture study requirementsEnsures assigned studies are conducted in accordance with FDA, OSHA, and Good Clinical Practice (GCP) guidelines in the following capacities:Ensures site compliance with research protocols by reviewing all regulatory requirements to confirm implementation of appropriate methods, practices, and procedures for all research activitiesDevelops accurate and appropriate source materials and ensures compliance from site staffProvides accurate and timely data collection, documentation, and reporting in both sponsor and site databasesEnsures appropriate credentialing and training of all staff members delegated to each studySupports the regulatory staff in the maintenance of regulatory documents in accordance with SOPs and applicable regulationsInterfaces with research subjects to support efforts to determine eligibility and consenting according to each protocolCommunicates study-specific requirements to the research team, including internal and external parties, sponsors, monitors, Principal Investigator and study subjectsProvides ongoing quality control audits including maintaining investigational drug and device accountabilityCollaborates with study team to identify and prioritize the development of systems and infrastructure to maintain research quality and complianceOther duties as assignedQualifications
- Expert at starting IVs, pediatric experience highly desirable
- Knowledge of accepted clinical research practices, including universal precautions, GCP, human subjects research protocols, and HIPAA requirements
- Knowledge of medical terminology and drug dosage calculation
- Ability to work independently and with careful attention to detail
- Excellent multi-tasking, organizational skills and ability to manage deadlines under pressure
- Excellent oral and written communication skills
- Ability to identify and solve problems with demonstrated initiative
- Proficiency in Microsoft Office, electronic health systems and databases used in research environments
- Must be able to establish rapport and communicate with subjects of diverse cultural and educational backgrounds.
Education and Experience - Bachelor of Science in Nursing or other scientific disciplines desired
- At least one year of experience in clinical research settings
- CCRC or other clinical research certification desired
Language Skills
The ability to read, write, and speak English clearly is mandatory. The ability to interpret documents such as safety rules, SOPs, and procedures is critical and an understanding of and ability to communicate in scientific language is desired. Spanish proficiency and/or fluency desired.
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