Clinical Trials Research Nurse Lead - Clinical Trials Office

Who is Saint Louis University? Founded in 1818, Saint Louis University is one of the nation’s oldest and most prestigious Catholic universities. SLU, which also has a campus in Madrid, Spain, is recognized for world-class academics, life-changing research, compassionate health care, and a strong commitment to faith and service.

JOB SUMMARY

The Clinical Trials Research Nurse Lead will serve as key staff in the Clinical Trials Office (CTO) supporting administrative functions within the CTO and acting as a centralized floating research nurse out in the departments, as needed. Under general supervision, the Clinical Trials Research Nurse Lead will have responsibility for oversight of clinical trials at the SLU School of Medicine. Responsibilities include screening, recruiting and enrolling subjects, data collection, coding and analysis, review, and management of budgets. The research nurse will act as liaison with core offices and service providers. The research nurse will be responsible for oversight and records maintenance for research studies. The position will require strong ability and skill for collaboration and problem solving, the ability to be adaptable and flexible.

PRIMARY JOB RESPONSIBILITIES

As a Floating Research Nurse (25%-50% of time bought out):

• Conduct assigned clinical studies.

• Serves as main contact with the IRB, clinical trials office, and study sponsors for research project start-up and execution for studies to which they are assigned.

• Assists with logistics and communicates with other departments as needed to execute projects.

• Coordinate protocol approval, contracts, budgets, regulatory adherence, and any additional needs for assigned research studies.

• Participate in pre-study activities such as regulatory document acquisition, study-specific training, investigator meetings and site initiation visits. May require travel.

• Supervises and trains students, residents, and research staff to carry out research per protocol. Participates in promoting Human Subjects Protections.

• Assesses the need for funding of research projects; promotes and assists with grant applications; review research expenses.

• Screen and recruit subjects for clinical studies; assess eligibility of potential subjects through methods such as screening interviews, review of medical records, and discussions with physicians and nurses.

• Oversee and participate in Informed Consent process, ensure that the informed consent process is properly documented, and that informed consent documents are filed as required.

• Oversees patient appointments as they pertain to research studies.

• Collaborates with physician clinic staff to manage the care of research participants and complete study activities.

• Perform study procedures related to efficacy and safety; obtain patients’ medical histories; administer study related questionnaires.

• Develop and maintain rapport and open communication with subjects and their families from diverse age, social backgrounds, and mental or physical status.

• Provide follow-up with subjects and their families to enhance adherence to study protocols and ensure opportunities for subjects and their families to ask questions regarding the study, study medication and treatment, general health care, by coordinating with the study nurse or principal investigator.

• Ensure compliance with CTU, SLU and SSM/Cardinal Glennon policies and procedures.

• Identifies protocol problems, informs investigators of problems, or assists in problem resolution efforts such as protocol revisions.

• Ensure study-related areas are organized and present a safe, accessible, effective, and efficient environment for employees, study subjects and families.

• Provide back-up and cross-coverage assistance for other clinical trials unit staff as needed.

• Submits documentation and correspondence for compliance with protocols.

• Prepares for or participates in monitoring visits and quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.

• Reviews clinical records/charts, intensive care records, medication, and patients’ responses for clinical intervention.

• Records adverse event and side effect data and confers with investigators regarding the reporting of events to oversight agencies.

• Complete and maintain source documentation and case report forms or research databases according to project requirements; reviews and assess data collected; addresses data queries; collaborates with investigator and statistical consultants.

• Oversees record maintenance of resea