Clinical/HC Research Associate - Gastroenterology/Hepatology
Company: The University of Iowa
Location: Iowa City
Posted on: September 19, 2023
The University of Iowa Health Care Department of
Gastroenterology/Hepatology is seeking a Clinical/HC Research
Associate to apply clinical skills requiring specialized licensing
to deliver and evaluate research protocols and clinical trials. The
position requires the academic knowledge of a specific discipline
and professional licensure in a clinically-related field related to
the study. Key areas of responsibility include research/clinical
activities, protocol development and study responsibilities,
subject recruitment and enrollment, data collection and monitoring,
regulatory guidelines and documents, human resources/leadership and
KEY AREAS OF RESPONSIBILITY
- Perform clinical/health care research activities in a
- Screen patient for study eligibility and consent for clinical
- Educate patient on scope of study, potential risks and
benefits, possible alternatives, and study requirements for
- Relay information to principal investigator and verify patient
- Administer study medication and identify adverse
- Administer study infusions; identify and respond to adverse
- Draw, process and ship labs.
Protocol Development and Study Responsibilities:
- Assist in the design, development, execution, administration
and maintenance of protocols and clinical studies and provide input
into descriptions of complex investigator initiated
- Coordinate and oversee the administration and maintenance of
clinical trial protocols.
- Manage patients with problems related to protocol.
- Oversee CRF development; develop complex study materials.
- Review query reports. Resolve all monitoring visit issues.
Assist with coordination of monitor visit schedule. Oversee the
monitor visits. Lead remote monitor visit calls.
- Participate and lead the site initiation visits.
- Perform and monitor randomizations.
- Serve as liaison to local health care practitioners, agencies,
- Ensure human subjects protection and provide care that is safe,
effective, and efficient.
Subject Recruitment and Enrollment:
- Screen, recruit, enroll and obtain informed consent for
clinical research activities and perform skilled work in a
specialized area of research.
- Oversee the recruitment of subjects and scheduling of
- Prepare study recruitment materials. Develop complex study
Data Collection and Monitoring:
- Participate in the design, development and testing of clinical
research trial data systems.
- Validate data and make recommendations for resolution.
- Revise and implement change in data collection.
- Oversee data entry and queries.
Regulatory Guidelines and Documents:
- Assist with the management and organization of regulatory
- Assist with the preparation of regulatory submissions.
- Perform on-site audits of research and clinical data.
- Assist with the monitoring of compliance of regulatory
guidelines and proper maintenance of documents.
- Assist with the preparation and presentation to the
Institutional Review Boards or other submissions and required
- Recommends corrective action for reportable events.
- May provide functional and/or administrative supervision.
- Mentor new staff under direction.
- Assist in the development of budget for studies. Contribute to
identification of increased cost/inefficient spending and cost
Ability to work with a variety of individuals and groups in a
constructive and civil manner while appreciating the unique
contribution of individuals from varied cultures, race, creed,
color, national origin, age, sex, disability, sexual orientation,
and gender identity.
Ability to utilize existing resources and learning to achieve or
exceed desired outcomes of current and future organizational
goals/needs. Able to demonstrate ethical behavior in diverse
situations while producing results.
Ability to meet or exceed customer service needs and expectations
and provide excellent service in a direct or indirect manner.
Ability to effectively transmit and interpret information through
appropriate communication with internal and external customers.
JOB FAMILY TECHNICAL COMPETENCIES
Knowledge of theories and methodologies of medical science
research; ability to use research processes, tools and technologies
to determine the safety and effectiveness of medical products and
services intended for human use.
Knowledge of and ability to provide clinical skills necessary for
patient care, education and/or treatment, e.g. history taking,
therapeutic planning and monitoring, diagnostic testing, etc., to
achieve optimized outcomes in therapy and clinical treatment.
Knowledge of the relevance of gathering health information used in
research for a specific project and appropriate documentation
methods; ability to analyze health data related to the project and
overall patient health.
Knowledge of practices, behaviors, applicable laws, rules, and
regulations governing proper research conduct; ability to
demonstrate ethical and compliant behavior in diverse
A Master's degree in nursing or an equivalent combination of
education and experience is required.
A current, valid Iowa Registered Nurse license is required.
6 months-1 year of nursing experience is required.
Excellent written and verbal communication skills are required.
Occasional overnight travel is required.
At least 1 year of clinical research experience is desired.
Experience with following specific protocol techniques and
management is desirable.
Knowledge of EPIC and experience with computer software
applications is desirable.
Phlebotomy experience is desirable.
In order to be considered for an interview, applicants must upload
the following documents and mark them as a "Relevant File" to the
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
Keywords: The University of Iowa, Iowa City , Clinical/HC Research Associate - Gastroenterology/Hepatology, Healthcare , Iowa City, Iowa
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