Clinical Trials Research Assistant/Associate - Pediatric Medical Genetics

UIOWA•Iowa City, IA

About The Position

The Stead Family Department of Pediatrics, Division of Medical Genetics, is seeking to hire a Clinical Trials Research Assistant or a 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. This position is not eligible for university sponsorship for employment authorization. About the Department of Pediatrics: The Stead Family Department of Pediatrics is a national leader pediatric medicine. The Department's mission is to provide outstanding care to the children of Iowa and beyond by being a leader in state-of-the-art clinical care to children, performing cutting-edge research to find new treatments and cures for childhood illnesses and educating the next generation of pediatric health care providers. The Department comprises the medical and research staff of UI Stead Family Children’s Hospital. UI Stead Family Children’s Hospital is one of the nation’s top-ranked pediatric care and research institutions, and Iowa’s only comprehensive children’s hospital.

Requirements

Bachelor’s degree in related field or an equivalency of education and/or related experience
Six months to one year of experience in clinical research.
Demonstrated excellent written, verbal, and interpersonal communication skills.
Knowledge of Institutional Review Board procedures, FDA regulations, GCP and study sponsor guidelines related to clinical trial research.
Demonstrated high attention to detail with strong organizational skills.
Minimum of two years of experience in clinical trial protocol management, including but not limited to preparation of regulatory submissions, recruitment of eligible patients, and reporting of study data

Nice To Haves

Six months to one year of experience in clinical trial protocol management.
Six months to one year of experience in data entry and management.
Demonstrated knowledge of or experience with medical genetic and lysosomal storage disorders.
Willingness and ability to travel.
One to three years of experience in clinical trial protocol management.
One to three years of experience in data entry and management.
CRC (Certified Clinical Coordinator) or CCRP (Certified Clinical Research Professional) certification, or a Master's degree in a related field (e.g. MPH)

Responsibilities

Assist with clinical and data coordination for research activities.
Screen, recruit, enroll and obtain informed consent for clinical trials.
Assist the PI in the completion of regulatory submission and 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 assist in developing a data management plan; design forms to facilitate the collection.
Design and coordinate field tests for data collection forms and assisting in design of certification procedures.
Perform daily activities for clinical trials; respond to clinical site questions regarding data collection and data entry issues.
Coordinate scheduling a preparation of trial-related procedures and subject visits.
Work closely with clinical trial home infusion company to coordinate subject visits and documentation.
Develop brochures or other materials for providers to support recruitment of study participants.
Attend training sessions as needed for the implementation of clinical trials.