Clinical Trials Research Assistant/Associate - Pediatric Medical Genetics

UIOWA•Iowa City, IA

12h

About The Position

The Stead Family Department of Pediatrics, Division of Medical Genetics, is hiring a Clinical Trials Research Assistant or Clinical Trials Research Associate to manage and coordinate clinical trials related to lysosomal storage disorders and other medical genetic disorders. This is a specified-term position and is not eligible for university sponsorship for employment authorization. The position supports clinical and data coordination for research activities, including participant screening, recruitment, enrollment, informed consent, and tracking of study data, drugs, biological specimens, and procedures. It also supports regulatory submissions and close-out processes, prepares regulatory documents for sponsor approval, and maintains and distributes information about open protocols and informed consents. The role consults with researchers on data management plans and collection forms, coordinates field tests and certification procedures, handles daily clinical-trial activities and data-related questions, and coordinates trial procedures and subject visits. It works closely with a clinical trial home infusion company on visits and documentation and develops recruitment materials for providers. Attendance at training sessions may be required for clinical-trial implementation. The department is a national leader in pediatric medicine. Its mission includes providing outstanding care to children, conducting research to advance treatments and cures, and educating future pediatric health care providers. It comprises the medical and research staff of UI Stead Family Children’s Hospital, a comprehensive children’s hospital and pediatric care and research institution.

Requirements

For the Clinical Trials Research Assistant level (PRV1): bachelor’s degree in a related field, or equivalent education and/or related experience.
For the Clinical Trials Research Assistant level (PRV1): six months to one year of clinical research experience.
For the Clinical Trials Research Associate level (PRV2): bachelor’s degree in a related field, or equivalent education and/or related experience.
For the Clinical Trials Research Associate level (PRV2): at least two years of clinical-trial protocol management experience, including regulatory submissions, recruitment of eligible patients, and study-data reporting.
Excellent written, verbal, and interpersonal communication skills.
Knowledge of Institutional Review Board procedures, FDA regulations, Good Clinical Practice (GCP), and study sponsor guidelines related to clinical-trial research.
Strong attention to detail and organizational skills.

Nice To Haves

For the Clinical Trials Research Assistant level (PRV1): six months to one year of clinical-trial protocol management experience.
For the Clinical Trials Research Assistant level (PRV1): six months to one year of data entry and management experience.
For the Clinical Trials Research Associate level (PRV2): one to three years of clinical-trial protocol management experience.
For the Clinical Trials Research Associate level (PRV2): one to three years of data entry and management experience.
Knowledge of or experience with medical genetic and lysosomal storage disorders.
Willingness and ability to travel.
CRC (Certified Clinical Research Coordinator) or CCRP (Certified Clinical Research Professional) certification, or a master’s degree in a related field such as an MPH (listed with the PRV2 desirable qualifications).

Responsibilities

Assist with clinical and data coordination for research activities.
Screen, recruit, enroll, and obtain informed consent from clinical-trial participants.
Assist the principal investigator with regulatory submissions and study close-out processes.
Track study participant data, study drugs, biological specimens, and study procedures.
Maintain and disseminate a list of open protocols and informed consents.
Prepare regulatory documents for sponsor approval.
Consult with researchers to develop data management plans and design data-collection forms.
Design and coordinate field tests for data-collection forms and assist in designing certification procedures.
Perform daily clinical-trial activities and respond to clinical-site questions about data collection and entry.
Coordinate scheduling and preparation of trial-related procedures and subject visits.
Work with the clinical-trial home infusion company to coordinate subject visits and documentation.
Develop brochures or other provider materials to support participant recruitment.
Attend training sessions as needed for implementation of clinical trials.