Clinical Trials Research Associate - Radiology
The University of Iowa Health Care department of Radiology is seeking a Clinical Trial & Data Management Research Associate to perform clinical/health care research activities in support of clinical trials in the Department. Assist in the design, development, execution, administration and maintenance of protocols and clinical studies. Screen, recruit, enroll and obtain informed consent for clinical research activities. Participate in the design, development, and testing of clinical research trial data systems. Manage and organized regulatory documentation.
Position Responsibilities:
- Functions as a member of the Theranostics Research team to plan, deliver, and evaluate the health care provided to research protocol patients.
- Assist in the development of protocols and clinical studies and provide input into complex research procedures.
- Resolve all monitoring visit issues.
- Develop complex study materials, including CRF and centralized monitoring documents.
- Assist physicians in determining eligibility of patients for research protocols.
- Educate study participants on scope of study, potential risks and benefits, and study requirements for participants.
- Assist in obtaining patient consent to enter protocols and counsel patients and families regarding investigational drug/therapy.
- Oversee operations of clinical research studies including the recruitment, coordination, and scheduling of subject participation and procedures per protocol requirements.
- Follows study participants; manages and directs collection of data including maintaining records of patient visits/interviews, documentation of adverse events and review of medication records. Provides documentation for physician review to ensure patients are screened and treated according to protocol.
- Schedule study related procedures and visits.
- Organize clinic/study procedures, follow study participants, and manage collection of accurate data in a timely manner, keeping data and documentation secure and confidential.
- Communicate with healthcare practitioners, agencies, and sponsors.
- Provide direction, assignments, feedback, coaching and counseling to assure research outcomes are achieved.
- Validate data, query resolution, and make recommendations for resolution.
- Maintain records and services provided and work within individual protocol budgets.
- Serve as a liaison to the University Business Office to identify specific patient tests and procedures paid for by study sponsors and assist with questions related to billing for protocol procedures.
- Perform on-site audits of research and clinical data including the design, development, and implementation of compliance testing criteria and tools.
- Monitor and control specific ethical/compliance issues such as proper consent, accurate recruitment materials, etc.
- Monitor compliance of regulatory guidelines and proper maintenance of documents.
- Participate in the adverse event reporting process, from initial data receipt to final submission.
- Use evaluation data to revise and implement change.
- Maintain effective working relationships with faculty, staff, students and the public.
- Assists in the preparation of reports to IRB-01, Protocol Review and Monitoring Committee and other review committees for multiple clinical research studies; compiles accrual data; reviews and summarizes information for principal investigators and University Institutional Review Board (IRB-01); Assists in maintaining documentation of protocols and relevant data, follow-up correspondence, and summaries.
- Performs critical analysis of literature relevant to the clinical trials.
- Educates faculty, staff and others about clinical research and methods employed in research studies; prepares educational materials for patients and other staff as needed to carry out protocol therapy.
- Selects, applies and tests standard methodologies, techniques and tools such as manuals, forms and questionnaires.
- Attends protocol meetings and other UIHC and Study Sponsor meetings; participates on committees as appropriate.
- Participates in the development of goals for the Theranostics Research program.
The information contained herein is not intended to be an exhaustive list of all responsibilities required of individuals performing this job.
University of Iowa Health Care—recognized as one of the best hospitals in the United States—is Iowa's only comprehensive academic medical center and a regional referral center. Each day more than 12,000 employees, students, and volunteers work together to provide safe, quality health care and excellent service for our patients. Simply stated, our mission is: Changing Medicine. Changing Lives. ®
Pay Grade: 4A https://hr.uiowa.edu/pay/pay-plans/professional-and-scientific-pay-structure-b
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
- For more information about Why Iowa?, click here
Education Required
- A Bachelor's degree or an equivalent combination of education and experience that is directly related to the duties of the position is required.
Required Qualifications
- Must have the ability to translate, adapt and apply knowledge and perform specialized research.
- Considerable (2-4 years) experience with and participation on clinical trials is required.
- Previous research protocol management experience is required.
- Experience with protocol and medical research data management is required.
- Knowledge of regulatory guidelines and procedures is required.
- Overnight and weekend travel may be required.
- Excellent written and verbal communication skills are required.
Desirable Qualifications
- Prior experience with Radiation and/or Radiology
- Knowledge of research billing.
- Knowledge of CMS clinical trials policies.
- Budget creation and negotiation
- Strong interpersonal skills.
- Strong organizational skills.
- Multi-institutional study management
- ACRP or SoCRA Certification
Application Process:
To be considered, applicants must upload a resume and a cover letter (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. Applications will be accepted until position is filled.
Successful candidates will be required to self-disclose any conviction history and will be subject to a criminal background check. For additional questions, please contact Lori Steffens at lori-steffens@uiowa.edu.
Equal opportunity/affirmative action employer
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, 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, gender identity, 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, (319) 335-2660 or fsds@uiowa.edu. For jobs in UI Health care, please contact UI Health care Leave & Disability Administration at 319-356-7543.
