Clinical Trials Research Assistant/Associate - Pediatric Medical Genetics

University of Iowa•Iowa City, IA

1d•$43,240 - $79,386

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, participant recruitment and enrollment, informed consent, regulatory submissions, study data and materials tracking, data-management planning, trial procedures, and subject visits. The position also coordinates with a clinical trial home infusion company, develops recruitment materials, and attends training as needed for clinical trial implementation. The Department of Pediatrics is a national leader in pediatric medicine. Its mission is to provide outstanding care to children, advance clinical care and research, and educate future pediatric health care providers. The department comprises the medical and research staff of UI Stead Family Children’s Hospital, a top-ranked pediatric care and research institution and Iowa’s only comprehensive children’s hospital. The position will be filled at one of two levels. The Clinical Trials Research Assistant (3A) salary range is $43,240–$66,199; the Clinical Trials Research Associate (4A) salary range is $47,380–$79,386. Applicants must indicate in their cover letter which level they wish to be considered for, or indicate both. A resume and cover letter must be uploaded and marked as required files. The posting will remain open for at least 14 calendar days and may be removed and filled afterward. Successful candidates must disclose conviction history and will undergo criminal background and credential/education verification checks. Up to five professional references may be requested later in the recruitment process.

Requirements

Bachelor’s degree in a related field, or equivalent education and/or related experience.
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.
High attention to detail and strong organizational skills.
For the Clinical Trials Research Assistant level (PRV1): six months to one year of experience in clinical research.
For the Clinical Trials Research Associate level (PRV2): at least two years of experience in clinical trial protocol management, including preparation of regulatory submissions, recruitment of eligible patients, and reporting study data.
The position is not eligible for university sponsorship for employment authorization.

Nice To Haves

For PRV1: six months to one year of experience in clinical trial protocol management.
For PRV1: six months to one year of experience in data entry and management.
For PRV2: one to three years of experience in clinical trial protocol management.
For PRV2: one to three years of experience in data entry and management.
Knowledge of or experience with medical genetics 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.

Responsibilities

Assist with clinical and data coordination for research activities.
Screen, recruit, and enroll clinical trial participants and obtain informed consent.
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 on data-management plans and design forms to facilitate data collection.
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 data-entry issues.
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 materials for providers to support participant recruitment.
Attend training sessions as needed for clinical trial implementation.