Clinical Research Coordinator III - Cancer Center

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.

The Clinical Research Coordinator III functions independently in the clinical research setting and is responsible for the complete coordination of assigned clinical research activities. The CRC III will support a PI sponsored Investigational New Drug (IND) or Investigational Device Exemption (IDE). This position will host and prepare for external audits (sponsor, FDA, NIH, etc.), educate and mentor clinical staff, research team and other coordinators, and assess protocol feasibility. The CRC III will also prepare, negotiate, manage study contract, develop and analyze Clinical Research activities for volunteer participants and make changes in methods and procedures as necessary.

• Conducts assigned clinical studies, maintenance of records according to study guidelines.

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

• Screens and recruits subjects for clinical studies; obtains patients' medical histories; attends investigation meetings; assesses eligibility of potential subjects through methods such as screening interviews, review of medical records, and discussions with physicians and nurses

• Participates in pre-study activities such as regulatory document acquisition, study-specific training, and site initiation visits; may require travel; assists PI with communication regarding study status with IRB and study sponsors

• Oversees and participates in Informed Consent process, ensures that the informed consent process is properly documented, and that informed consent documents are filed as required; performs study procedures related to efficacy and safety; administers study related questionnaires

• Develops and maintains rapport and open communication with subjects and their families from diverse age, social backgrounds, and mental or physical status; provides follow-up with subjects and their families to enhance adherence to study protocols and ensures 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; provides back-up and cross-coverage assistance for other clinical trials unit staff as needed; ensures study-related areas are organized and presents 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

• Completes and maintains source documentation and case report forms according to project requirements; assists with maintenance of study file documentation; participates in monitoring visits and audits

• Performs other duties as assigned

• Highly effective communication skills with diverse populations

• Strong decision making and critical thinking skills and abilities

• Strong attention to accuracy and detail

• Advance Microsoft Office support tools and spreadsheet software

• Teamwork and collaboration skills

• Dedicated to self-directed growth, development, and active learning

• Knowledge of clinical operational functions

• Supervisory skills

• Ability to build effective interpersonal relationships

• Bachelor's degree

• Three years of relevant experience

Function

Scheduled Weekly Hours:

Saint Louis University is an equal opportunity/affirmative action employer. All qualified candidates will receive consideration for the position applied for without regard to race, color, religion, sex, age, national origin, disability, marital status, sexual orientation, military/veteran status, gender identity, or other non-merit factors. If accommodations are needed for completing the application and/or with the interviewing process, please contact Human Resources at 314-977-5847.