What are the responsibilities and job description for the Clinical Trials Research Associate - Pediatrics Medical Genetics position at The University of Iowa?
The Stead Family Department of Pediatrics, Division of Medical Genetics, is seeking to hire a Clinical Trials Research Associate to manage and coordinate clinical trials related to lysosomal storage disorders and other medical genetic disorders.
Duties include:
- Screen, recruit, enroll and obtain informed consent for clinical trials.
- Oversee the recruitment of subjects and scheduling of trial-related procedures.
- Educate study participants on scope of study, potential risks and benefits, possible alternatives, and study requirements for participants. Relay information to principal investigator and verify study participant eligibility.
- Prepare regulatory submissions.
- Assist the PI in the completion of regulatory submission and close-out processes.
- Track study participant data, study drugs, biological specimens and study procedures.
- Coordinate with Clinical Research Unit and ICTS.
- Prepare regulatory documents for sponsor approval.
- Support PI with monitoring visit reports for all studies.
- Perform daily activities for clinical trials; respond to clinical site questions regarding data collection and data entry issues.
- Work closely with clinical trial home infusion companies to coordinate subject visits and documentation.
- Assist in managing data validation, query resolutions, and the reporting of data; conduct audits to assess quality assurance.
For a full job description, please email pedsuichildrens@healthcare.uiowa.edu.
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.
Required Qualifications:
- Bachelor’s degree in related field or an equivalency of education and/or related experience.
- Minimum 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.
- 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.
Highly Desirable Qualifications:
- One to three years of experience in data entry and management.
- Demonstrated knowledge of or experience with medical genetic and lysosomal storage disorders.
- Experience with statistical analysis using SAS, R, and Microsoft Access.
- CCRC (Certified Clinical Research Coordinator) or CCRP (Certified Clinical Research Professional) certification, OR a master’s degree in a related field (e.g. MPH).
- Willingness to travel.
Position and Application Details:
In order to be considered for an interview, applicants must upload the following documents and mark them as a “Required File” to the submission:
- Resume
- Cover Letter stating what position you are applying for.
Job openings are posted for a minimum of 14 calendar days and may be removed from posting and filled any time after the original posting period has ended.
Successful candidates will be required to self-disclose any conviction history and will be subject to a criminal background check and credential/education verification. Up to 5 professional references will be requested at a later step in the recruitment process.
For additional questions, please contact Bradley at Pedsuichildrenshr@healthcare.uiowa.edu.
This position is not eligible for university sponsorship for employment authorization.
