The Holden Comprehensive Cancer Center (HCCC) at the University of Iowa Hospitals and Clinics is seeking a Clinical Trials Research Associate to serve as a member of the Clinical Trials Research team to coordinate clinical oncology study activities: assist in the planning, delivery and evaluation of health care provided to research protocol patients; work closely with Clinical Research Coordinators in the collection of data and in close collaboration with multiple departments and offices, including the University Clinical Trials Office; maintain medical documentation, binders and files; manage data entry and electronic data systems for clinical research protocols and laboratory investigations currently being conducted within the Holden Comprehensive Cancer Center (HCCC) at The University of Iowa.
Functions as a member of the Clinical Trials Research team to plan, deliver, and evaluate the health care provided to research protocol patients.
Creates, populates, maintains, and enhances multiple databases containing clinical and research information obtained through review of patient charts and samples, lab reports and other related information and in a manner that complies with Institutional Review Board requirements and in response to physician and research needs and requirements.
Assists in the design, development, execution and administration of data entry for protocols and clinical studies.
Assists in the operations of clinical research studies including the recruitment, coordination and scheduling of subject participation and procedures as required by protocol.
Follows study participants; manages collection of data including maintaining records of patient visits/interviews.
Enters protocol patient data on electronic databases ensuring that all prerequisites have been completed and are within the required parameters.
Monitors compliance, gathers and maintains data for pharmaceutical sponsored research trials, in-house trials and cooperative group studies; creates worksheets, treatment flow sheets and assorted tools to provide source documentation of protocol treatment procedures; triages telephone calls from patients and families to facilitate clinic visits for medical care/emergent care needs; assists in obtaining prescription medications; provides follow-up for treatment related complications.
Serves as liaison to local physicians/hospitals to facilitate care of protocol patients when hospitalized at outside institutions; obtains documentation of the hospitalizations; provides notification to the Principal Investigator, Study Sponsor, and FDA as required per protocol.
Assists in judging validity of data; makes recommendations; performs and interprets statistical analysis of data; prepares data for computer analysis; uses evaluation data to revise and implement change in close collaboration with the clinical research coordinator.
Assists in the preparation of periodic and special reports, including 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.
Assists in the preparation of materials for reports to be written by faculty and staff on various oncology protocols and in compiling summary data for inclusion in various reports used for analysis and submission to study sponsors.
Coordinates ongoing research collaborations with outside institutions (such as Mayo Clinic and Johns Hopkins) ensuring that data is collected and entered in appropriate electronic records in a manner consistent between the institutions
Participates in the development of general goals for the Clinical Trials Support Services.
Processes and ships diagnostic specimens.
Attends protocol meetings and other UIHC and Study Sponsor meetings; participates on committees as appropriate.
Schedule: Monday through Friday, 8:00 AM to 5:00 PM, onsite only
Bachelor’s degree or an equivalent combination of education and experience.
Minimum 1 year of clinical research experience or medical research data management experience.
Excellent verbal, written and interpersonal communication skills.
Proficient in computer software applications.
Ability to manage complex information with attention to detail and a high level of accuracy
Relevant experience in the conduct of both clinical and laboratory oncology research studies.
Knowledge of regulatory guidelines and procedures.
Experience with adult oncology patient population.
Clinical Research Coordinator Certification (SOCRA or ACRP).
Knowledge of University of Iowa policies, procedures and regulations.
Please apply here: Clinical Trials Research Associate
Holden Comprehensive Cancer Center is Iowa’s only NCI-designated comprehensive cancer center. The NCI designation recognized our cancer center, and its research scientist, physicians, and other health care professionals, for their roles in advancing cancer research that impacts on our ability to prevent, detect and treat our patients with cancer. Not just a floor, or a building, or even confined to a single college. Holden Comprehensive Cancer Center coordinates all cancer-related research, education, and patient care by faculty from 41 departments and six colleges, as well as UI Hospitals and Clinics and UI Children’s Hospital.
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.