Washington University in St. Louis is seeking a lead person for a research project to coordinate study subject enrollment, ensure adherence to study procedures, and maintain continuity of care and human subject protection.
Requirements
- Basic Life Support certification (Online BLS certifications, those without a skills assessment component, are not sufficient to meet the BLS requirements).
- Clinical Research Certification.
- Active Listening
- Clinical Research Coordination
- Clinical Research Management
- Clinical Research Methods
- Clinical Research Operations
Responsibilities
- Works under the Principal Investigator’s (PI) guidance to meet the research objective of the project.
- Facilitates and implements study start-up activities including (but not limited to): trial feasibility assessment; study logistics; IRB (both local and central) submissions and other applicable regulatory requirements; budgetary and contract review and approval.
- Provides direct patient care, including assessment, planning, implementation and evaluation of patients; documents, collects data and assists physicians.
- Works with research team to identify, screen and enroll study subjects.
- Ensures protocol requirements are met including (but not limited to): direct contact with research participants; collection of basic health information; coordination of study related procedures; handling, processing and shipping of research specimens, source documentation and data entry.
- Coordinates handling of specimens, administration of clinical trials, collection of source information and case reporting.
- Prepares/submits reportable event reports to sponsor(s), IRBs and regulatory agencies in accordance with the study protocol and established policies, procedures, and regulations.
Other
- Functions as the lead person on a research project; coordinates enrollment of study subjects; ensures adherence to study procedures consistent with the study protocol and verifiable source documentation.
- May supervise personnel assigned to work on the study.
- Coordinates with multidisciplinary teams to maintain continuity of care and human subject protection with a commitment to research integrity.
- Demonstrates experience in clinical trials management including strong organizational skills, independence and resourcefulness and an increased responsibility for the day-to-day conduction and oversight of multiple clinical trials.
- Educates staff nurses caring for research patients by providing necessary information about the research study including intervention and potential adverse events and required study procedures.
