Within the Stead Family Department of Pediatrics, Division of Pulmonary Medicine, the Research Associate will evaluate clinical research protocols, conduct and manage clinical trials, study protocol design and protocol development, study subject recruitment and enrollment, study visit scheduling, planning and conduct, data collection and analysis, scientific writing, regulatory file maintenance in accord with FDA requirements, and clinical study financial management.
This is a specified term position.
We intend to hire for one position at either the Research Associate, requisition #24002370, or Research Assistant, requisition #24002372, based on the qualifications of the successful candidate.
Please apply to the position you wish to be considered for or both.
Position Responsibilities
· Screen, recruit, enroll and obtain informed consent for clinical trials.
· Consent of study participants – review the scope of study, potential risks and benefits, possible alternatives, and study requirements for participants.
Relay information to principal investigator and verify study participant eligibility.
· Track study participant data, study drugs, biological specimens, and study procedures.
· Submit applications to the Clinical Research Unit (CRU) and the Institute for Clinical and Translational Science (ICTS), prepare medical order drafts, and train CRU staff.
· Create, populate, maintain, and enhance databases containing clinical and research information obtained through patient interviews and questionnaires, review of patient charts, collection of samples in a manner that complies with IRB.
· Consult with each study’s Principal Investigator (PI) to design forms that facilitate the collection and tracking of participant data, study drugs and study procedures.
· Work with study monitors provided by the studies sponsor to facilitate review and processing of study documents.
This includes hosting of study monitor visits to the laboratory, response to monitor quires and resolution of all issues raised by the monitor.
For a full job description, please send an e-mail to pedsuichildrenshr@healthcare.
uiowa.
edu.
About the Stead Family Department of Pediatrics
The Stead Family Department of Pediatrics is a national leader in 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.
Division of Pulmonary Medicine
The Division of Pediatric Pulmonary Medicine is committed to providing outstanding clinical care, education for trainees of all levels, and the advancement of knowledge through the pursuit of biomedical research.
Clinical services are provided in the outpatient setting and in the University of Iowa Stead Family Children’s Hospital care units.
We are regionally and nationally recognized for our expertise.
Education Requirements:
Bachelor’s degree in related field or equivalent combination of education and/or related experience.
Experience Requirements:
Minimum one year 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 and study sponsor guidelines related to clinical trial research.
Demonstrated proficiency with Microsoft Office and software applications.
Demonstrated high attention to detail with strong organizational skills.
Highly Desired Qualifications:
Research Professional certification.
A graduate degree in a related field (e.
g.
, MPH).
Demonstrated knowledge of methods for gathering scientific data, compiling, and analyzing those data, and generating reports that document the scientific results of specific projects.
Desired Qualifications:
Experience creating budgets, invoicing, and tracking payments.
Experience and/or training in statistical analysis.
Demonstrated experience and proficiency with medical terminology.
Willingness and ability 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 “Relevant File” to the submission:
Resume
Cover Letter indicating what job 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 pedsuichildrenshr@healthcare.
uiowa.
edu
This position is not eligible for University sponsorship for employment authorization.
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