This position is within the Pediatric Clinical Trials Unit, primarily coordinating clinical trials and research studies for the Division of Pediatric Nephrology.
Under general supervision, coordinates clinical studies; compiles, enters, reviews, and assesses data for clinical studies; recruits, screens and enrolls subjects; manages multiple study protocols simultaneously.
Knowledge, Skills, Abilities and Personal Characteristics
Â·Â Â Â Â Â Â Â Â Knowledge of specialized medical/scientific terminology
Â·Â Â Â Â Â Â Â Â Knowledge of medication and proper dosages
Â·Â Â Â Â Â Â Â Â Ability to maintain confidentiality
Â·Â Â Â Â Â Â Â Â Ability to type and operate a personal computer
Â·Â Â Â Â Â Â Â Â Ability to analyze and interpret statistical data
Â·Â Â Â Â Â Â Â Â Above average verbal, written and interpersonal communication skills
Â·Â Â Â Â Â Â Â Â Capable of relating to diverse age and demographic backgrounds
Â·Â Â Â Â Â Â Â Â Demonstrate diplomacy, tact, and professional demeanor
Â·Â Â Â Â Â Â Â Â Possess organizational skills, analysis, supervision, and prioritization abilities
Â·Â Â Â Â Â Â Â Â Ability to have flexible hours to meet study protocol and subjects' needs
Job Duties and Responsibilities
Conduct assigned clinical studies including recruitment, enrollment, data collection, database entry, follow-up, and record maintenance according to study guidelines. Participate in pre-study activities such as completion of regulatory documents, study-specific training, and site initiation visits. May require travel.
Ensure the quality and integrity of assigned studies in accordance with study protocol, federal and local regulations, Institutional Review Board (IRB) processes, and local policies and procedures.Â Conduct ongoing quality control audits.
Assist PI with communication regarding study status with IRB and study sponsors.
Understand IRB procedures and regulatory practices.Â Complete IRB applications, renewals, amendments, and safety reports.Â
Participate in the Informed Consent process. Perform study procedures related to efficacy and safety. Administer clinical trial drugs, therapies, etc. according to study protocols.
Complete and maintain source documentation and case report forms, according to project requirements. Assist with maintenance of study file documentation. Participate in monitor visits and audits.
Develop and maintain rapport and open communication with subjects and their families of diverse age, social background, and mental or physical status. Provide follow-up with subjects and their families to enhance adherence to study protocols and to provide opportunities for subjects and their families to ask questions regarding the study, study medication, and treatment, or general health care.
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. Comply with CTU, SLU, and SSM/Cardinal Glennon policies and procedures. Maintain current knowledge for professional issues through formal and informal educational meetings. Perform other duties as assigned.
Graduation from an approved RN Program, with Bachelor's Degree in Nursing, preferred; supplemented with a Missouri RN License, and two (2) years of related experience in pediatric healthcare or clinical research. Prior experience in both fields is preferred.
Saint Louis University(SLU) is a private, co-educational Jesuit university located in St. Louis, Missouri, United States. Founded in 1818 by the Most Reverend Louis Guillaume Valentin Dubourg SLU is the oldest university west of the Mississippi River. The University has campuses in St. Louis, Mo. and Madrid, Spain. SLU values academic excellence, life-changing research, compassionate health care, and a strong commitment to faith and service. For nearly 200 years, the University has gone beyond teaching facts and figures, encouraging students to form ideas and identities. Today, SLU students are nearly 14,000 strong. The University has invested vast resources to advance academic programs and enhance the student experience. SLU also is a major research institution where premier researchers tackle local and global challenges. And the University's commitment to community service has earned it national acclaim and bolstered its status as a character-building college.