Clinical Trials Research Assistant - Radiation Oncology

Other Key Duties Include

The University of Iowa Hospitals and Clinics Department of Radiation Oncology is seeking a Clinical Trials & Data Management Research Assistant to join our Clinical Research team to support, conduct and manage clinical trials to deliver and evaluate research protocols. Key areas of responsibility include protocol development/ management and study responsibilities; research/clinical activities, subject recruitment and enrollment, data collection and monitoring; regulatory guidelines and documents and financial responsibilities.

Protocol Development/ Management and Study Responsibilities: Consult with researchers to assist in developing a data management plan; design forms to facilitate the collection and tracking of study participant data, study drugs, biological specimens and study procedures. Design and coordinate field tests for data collection forms and assisting in the design of certification procedures.

• Communicates with sponsors
• Research, change, and submit protocol amendments for IRB approval.
• Monitors protocol status as it is process through the IRB.
• Consults with researchers and assist in the design, development, execution, administration and maintenance of protocols and clinical studies.
• Manages and maintain protocols.
• Prepares IRB documents for protocol approval, modifications and yearly renewals
• Responsible for conducting training of new protocols and changes to existing protocols.

Research/ Clinical Activities; Subject Recruitment and Enrollment: May assist with clinical and data coordination for research activities. May screen, recruit, enroll and obtain informed consent for clinical trials.

• Assist with subject recruitment by mining databases and EPIC.
• Assist in retrieval of basic study data as it pertains to specimens.
• Assists with clinical and data coordination for research activities and set up supplies for study visits.
• Assists with subject recruitment, consenting and enrollment of subjects from the providers clinics in Radiation Oncology.

Data Collection and Monitoring: Assist in managing data validation; query resolutions, and the reporting of data; conduct audit to assess quality assurance. Perform all data processing tasks; enter data, verify data, identify problem data, generate queries, etc. Coordinate the processing of data from various sites/centers/studies.

• Participates in clinical research visits, which includes Epic documentation, checking vitals, and drawing blood.
• Responsible for site management and daily activities associated with a clinical trial; respond to clinical site monitoring questions regarding data collection and data entry issues.
• Monitors visit reports for studies.
• Submits protocol data, yearly renewals, and study modifications to the IRB in a timely fashion.

Regulatory Guidelines and Documents: Conduct audit to assess quality assurance. Develop procedures for on-site data audits; participate in audits; design and generate reports for use in data audits; summarize results of audits and write reports.

• Completes regulatory submission and close out process.
• Monitors compliance of regulatory guidelines and proper maintenance of documents.
• Prepares regulatory documents for sponsor approval.
• Manages and organizes regulatory documentation from sites and regulatory authorities.

Human Resources/ Leadership: May provide functional and/or administrative supervision.

• May train and mentor new staff related to protocols and clinical studies.

University of Iowa Hospitals & Clinics—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.®

Percent of Time: 100%

Schedule: Monday – Friday, 8-hour day shifts

Appointment Type: P&S

Pay Level 3A https://hr.uiowa.edu/pay/guide-pay-plans

Benefits Highlights

• For more information about Why Iowa?, click here
• 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

Required Qualifications

• Excellent written, verbal and interpersonal communication skills.
• Strong organizational skills.
• Ability to manage complex information with attention to detail and a high level of accuracy
• Basic experience and participation with clinical trials, following specific protocol techniques and management.
• A Bachelor of Science degree of an equivalent combination of education and experience.
• Proficiency in computer applications (MS Word, Excel, Outlook, PowerPoint).

Desirable Qualifications

• 6 months to 1 year of related experience in Oncology.
• Knowledge of University of Iowa policies, procedures and regulations
• Experience conducting electrocardiograms (ECG)
• Experience working with Epic and OnCore databases.
• Experience with laboratory functions including processing specimens per protocol, as well as storage of specimens, maintaining lab areas, inventories, orders.
• Current IATA certification (International Air Transportation).

Application Process: To be considered, applicants must upload a resume and 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.

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 Joleen Timm at [email protected]

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

Additional Information

• Classification Title: Clin Trials Rsrch Asst/Data Mg
• Work Modality Options: On Campus
• Schedule: Full-time
• Appointment Type: Professional and Scientific

Compensation

• Pay Level: 3A

Contact Information

• Organization: Healthcare
• Contact Name: Joleen Timm
• Contact Email: [email protected]