Clinical Research Coordinator III - Pediatrics

Saint Louis University•SLU Saint Louis, MO

About The Position

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: Under administrative direction 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). Host and prepare for external audits (sponsor, FDA, NIH, etc.) Educate and mentor clinical staff, research team and other coordinators. Assess protocol feasibility. Prepare, negotiate, manage study contract. Develop and analyze Clinical Research activities for volunteer participants and make changes in methods and procedures as necessary. This role may also have supervisor responsibilities.

Requirements

Ability to build effective interpersonal relationships
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
Dedicated to self-directed growth, development, and active learning
Knowledge of clinical operational functions
Supervisory skills
Bachelor’s degree in an appropriate area and three years of relevant experience; or an equivalent combination of education and experience.

Nice To Haves

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.