Clinical Trials Research Associate-Urology

The University of Iowa

Job Reference #: 22001623

The Department of Urology at The University of Iowa Hospitals and Clinics is seeking a Clinical Trials Research Associate to design, plan, promote and control clinical trials and coordinate the processing and analysis of trials data. Key areas of responsibility include protocol development/management and study responsibilities; research/clinical activities, subject recruitment and enrollment, data collection and monitoring; regulatory guidelines, documents and submission; and human resources/leadership.

Duties to include:

Protocol Development/Management and Study Responsibilities:

  • Assist in the design, development, execution, administration and maintenance of protocols and clinical studies.
  • Oversee CRF development
  • Review query reports.
  • Meet with study monitor. Resolve all monitoring issues.
  • Develop complex research study materials.
  • Initiate IRB submissions, renewals and communication with constituents.
  • Liaise with multi-center health care practitioners, agencies and sponsors.

Research/Clinical Activities: Subject Recruitment and Enrollment:

  • Responsible for the management and daily activities associated with the assigned projects.
  • Assist with clinical and data coordination for research activities and set up supplies for study visits and schedule trial-related procedures.
  • Oversee the recruitment of subjects. Screen, recruit enroll and obtain informed consent for clinical trials.
  • Oversee the recruitment of subjects by mining databases and EPIC and recruiting subjects from the providers clinics.
  • Educate study participants on scope of study, potential risks and benefits, possible alternatives and study requirements.
  • Relay information to principal investigator and verify study participant eligibility.
  • Collect and document participant study activities.

Data Collection and Monitoring:

  • Participate in the design; development and testing of clinical research trials data systems.
  • Validate data, query resolution and make recommendation for resolution.
  • Revise and implement change in data collection.
  • Perform all data processing tasks; enter data, verify data, identify problem data, generate queries, etc.
  • Track study participant data.

Regulatory Guidelines and Documents:

  • Manage and organize regulatory documentation from sites and regulatory authorities.
  • Prepare regulatory submissions and start-up activities for new studies.
  • Perform on-site audits of research and clinical data.
  • Monitor compliance of regulatory guidelines and proper maintenance of 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 manage budget for studies in coordination with Urology Research Administration.

Percent of Time: 100%

Pay Grade: 4A - -

Required Qualifications

  • A Bachelor’s degree or an equivalent combination of education and experience is required.
  • Minimum one year experience in clinical research.
  • Knowledge of regulations, guidelines and procedures that apply to human research.
  • Prior experience with Institutional Review Board (IRB) application materials and processing.
  • Excellent written, verbal and interpersonal communication skills.
  • Experience in coordinating multiple projects and diverse functions independently.
  • Proficiency with computers, software and database systems.

Desirable Qualifications

  • Knowledge of University of Iowa policies, procedures and regulations.
  • Experience with following specific protocol techniques and management.
  • Experience working in an academic research institution.
  • Knowledge of urology and cancer research.

This position is not eligible for University sponsorship for employment authorization.

The University of Iowa is an equal opportunity/affirmative action employer. All qualified applicants are encouraged to apply and will receive consideration for employment free from discrimination on the basis of race, creed, color, national origin, age, sex, pregnancy, sexual orientation, gender identity, genetic information, religion, associational preference, status as a qualified individual with a disability, or status as a protected veteran.

Job Benefits:

Benefits Highlights:

  • Regular salaried position located in Iowa City, Iowa
  • Fringe benefit package including paid vacation; sick leave; health, dental, life and disability insurance options; and generous employer contributions into retirement plans
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Application Instructions:

Application Process: In order to be considered, applicants must upload cover letter and resume (under submission relevant materials) that clearly address how they meet the listed required and desired qualifications of this position.

Job openings are posted for a minimum of 14 calendar days or until position is filled.

Successful candidates will be subject to a criminal background check.

Job ID: 81252

Posted 3 days ago

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