Clinical / HC Research Associate

University of Iowa

Iowa City, IA Scientific / Healthcare $49,031 yearly

Job Reference #: 18001262

Classification Title: Clinical/HC Research Associate
Pay Grade: 5A 
Salary: $49,031 – commensurate
Percent of Time: 100%
Staff Type: Professional & Scientific
Type of Position: Specified Term

Please attach a resume and 3 references as part of the application process. Job openings are posted for a minimum of 14 calendar days. This job may be removed from posting and filled any time after the minimum posting period has ended. For questions or additional information, please contact Successful candidates will be subject to a criminal background check and health screening.

Position Summary: Apply clinical skills requiring specialized licensing to deliver and evaluate research protocols and clinical trials in the Gastroenterology and Hepatology Division of Internal Medicine. 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 financial responsibility.

Position Responsibilities: 
Research/Clinical Activities:
Perform clinical/health care research activities in a skilled/specialized area.
Screen patient for study eligibility and consent for clinical trials.
Educate patient on scope of study, potential risks and benefits, possible alternatives, and study requirements for patient.
Relay information to principle investigator and verify patient eligibility.
Administer study medication and identify adverse reactions.

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 research procedures.
Assist patients with problems related to protocol. Oversee CRF development.
Review query reports. Resolve all monitoring visit issues.
Perform and monitor randomizations.
Develop complex study materials.
Serve as liaison to local health care practitioners, agencies, and sponsors.

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 trial-related procedures.
Prepare study recruitment materials. Develop complex study recruitment materials.

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.

Regulatory Guidelines and Documents:
Manage and organize regulatory documentation.
Prepare regulatory submissions.
Perform on-site audits of research and clinical data.
Monitor compliance of regulatory guidelines and proper maintenance of documents.
Prepare and present Institutional Review Boards or other submissions and required regulatory documents.
May recommend corrective action for reportable events.

Human Resources/Leadership:
May provide functional and/or administrative supervision.
Mentor new staff under direction.
Financial Responsibility:
May develop and administer budget for studies.

Education Required
  • A Master’s degree in nursing or an equivalent combination of education and experience is required.
Experience Requirements
  • 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.
  • 1 year of clinical research experience is required.
  • Excellent written and verbal communication skills are required.
  • Occasional overnight travel is required.

Desirable Qualifications
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.

Job ID: 66239

Posted 14 days ago

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