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Saint Louis University · 6 days ago

Clinical Research Coordinator III - Cancer Center

SLU Saint Louis, MO

Full-time

Onsite

Mid Level

3+ years exp

Saint Louis University is one of the nation’s oldest and most prestigious Catholic universities. The Clinical Research Coordinator III is responsible for the complete coordination of assigned clinical research activities, supporting Investigational New Drug (IND) or Investigational Device Exemption (IDE) studies, and mentoring clinical staff. This role involves conducting clinical studies, ensuring compliance, and maintaining effective communication with study subjects and their families.

EducationHigher EducationUniversities

Responsibilities

Conduct assigned clinical studies, maintenance of records according to study guidelines. Ensure compliance with CTU, SLU and SSM/Cardinal Glennon policies and procedures

Screen and recruit subjects for clinical studies; obtain patients’ medical histories; attend investigation meetings. Assess eligibility of potential subjects through methods such as screening interviews, review of medical records, and discussions with physicians and nurses

Participate in pre-study activities such as regulatory document acquisition, study-specific training, and site initiation visits. May require travel. Assist PI with communication regarding study status with IRB and study sponsors

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. Perform study procedures related to efficacy and safety; administers 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. Provide back-up and cross-coverage assistance for other clinical trials unit staff as needed. Ensure study-related areas are organized and present a safe, accessible, effective, and efficient environment for employees, study subjects and families

Reviews clinical records/charts, intensive care records, medication, and patients’ responses for clinical intervention. Compiles and enters clinical data into database; reviews and assesses data collected; collaborates with investigator and statistical consultants; submits documentation and correspondence for compliance with protocols. Records adverse event and side effect data and confers with investigators regarding the reporting of events to oversight agencies. Prepares for or participates in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups. Identifies protocol problems, informs investigators of problems, or assists in problem resolution efforts such as protocol revisions

Complete and maintain source documentation and case report forms according to project requirements. Assist with maintenance of study file documentation. Participate in monitoring visits and audits

Performs other duties as assigned

Qualification

Clinical research coordinationRegulatory complianceInformed consent processMicrosoft OfficeSupervisory skillsInterpersonal relationshipsCommunication skillsDecision makingAttention to detailTeamwork