Clinical Trials Research Associate - Urology

Clinical Trials Research Associate - Urology

University of Iowa Healthcare, Department of Urology seeks to hire a full-time 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.

Position Responsibilities:

Protocol Development/Management and Study Responsibilities:

Assist in the design, development, execution, administration and maintenance of protocols and clinical studies.

Oversee CRF development

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.

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.

May develop and manage budget for studies in coordination with Urology Research Administration.

Required Qualifications:

A Bachelor’s degree or an equivalent combination of education and experience is required.

Minimum 1 year of clinical research or related experience.

Excellent written, verbal and interpersonal communication skills.

Ability to manage complex information with attention to detail and a high level of accuracy.

Proficient in computer software applications.

Desirable Qualifications:

Prior experience in database software applications (RedCap, BioShare, etc.).

Knowledge of regulations, guidelines and procedures that apply to human research.

Prior experience with Institutional Review Board (IRB) application materials and processing.

Experience in data collection and entry.

Experience in processing research regulatory documents.

Knowledge of University of Iowa policies, procedures and regulations.

Prior experience in academic medicine, healthcare, or research organization

Knowledge of urology and cancer research.

• Appointment Type: Professional and Scientific
• Schedule: Full-time
• Work Modality Options: Hybrid within Iowa

Compensation

Contact Information

• Contact Name: Sandy Moenk
• Contact Email: View email address on click.appcast.io

Equal opportunity employer

The University of Iowa is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment free from discrimination on the basis of race, creed, color, religion, national origin, age, sex, pregnancy (including childbirth and related conditions), disability, genetic information, status as a U.S. veteran, service in the U.S. military, sexual orientation, or associational preferences.

Persons with disabilities who need assistance or accommodations with the application or interview process may contact University Human Resources/Faculty and Staff Disability Services, View phone number on click.appcast.io or View email address on click.appcast.io . For jobs in UI Health care, please contact UI Health care Leave & Disability Administration at View phone number on click.appcast.io .