University of Iowa Research · 1 week ago
Clinical Trials Research Associate - Cancer Center
Iowa City, Iowa, United States
Full-time
Onsite
Entry, Mid Level
2+ years expThe University of Iowa Research is seeking a Clinical Trials Research Associate to coordinate clinical oncology study activities at the Holden Comprehensive Cancer Center. The role involves planning, delivering, and evaluating health care for research protocol patients, managing data collection, and collaborating with various departments to ensure patient safety and compliance with clinical trial protocols.
Research
No H1B
Responsibilities
Functions as a member of the Clinical Research Services team to plan, deliver, and evaluate the health care provided to research protocol patients
Assists in the design, development, execution and administration for protocols and clinical studies
Oversees operations of clinical research studies including the recruitment, screening, coordination and scheduling of subject participation and procedures as required by protocol
Obtains informed consent; educates study participants on the scope of study, schedule of events per clinical trial protocol and requirements of participation
Follows study participants; manages 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
Documents medical histories, symptoms, vital signs, treatments and results for assigned patients according to research protocol; reviews results to ensure quality and accuracy of data gathered; communicates with physician to assist in eligibility determination
Monitors compliance, gathers and maintains data for pharmaceutical sponsored research trials, in-house trials and cooperative group studies; develops complex study materials; creates worksheets, treatment flow sheets and assorted tools to ensure accurate source documentation of protocol treatment procedures; triages telephone calls from patients and families to facilitate clinic visits for medical care/emergency care needs; assists in obtaining prescription medications; ensures follow up care is conducted in alignment with clinical trial protocol
Collaborates with departments of Radiology, Pathology, Pharmacy, Nursing, Holden Comprehensive Cancer Center, Clinical Research Unit and/or other departments participating in the clinical research to ensure multi-disciplinary patient safety approaches; conveys study specific objectives and requirements; develops communication tools as necessary
Enters patients on protocol, ensuring that all prerequisites have been completed and are within the required parameters
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
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
Reviews all query reports and resolves all monitoring issues
Participates in the development of general goals for the Clinical Trials Support Services
Ensures time, energy, learning opportunities, and actions are focused on creating a safe, fair and respectful work environment and improving the workplace
Coaches others on clinical skills, knowledge, and effective individualized patient care
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 principal investigator
Comply with UI policies and procedures
Maintain knowledge of departmental SOPs; ensure personal practice is in line with SOPs
Attends protocol meetings and other University of Iowa Health Care and Study Sponsor meetings; participates on committees as appropriate
Seeks professional development opportunities
Maintain primary coordination responsibilities of up to 5 studies actively recruiting patients
Ability to enroll up to 16 new patients on trial in a calendar year
Qualification
Required
A Masters degree or equivalent combination of education and professional nursing experience
2 years of experience in nursing and/or clinical research
Current valid Iowa Registered Nurse license
Excellent verbal, written and interpersonal communication skills
Proficient in computer software applications
Ability to organize and evaluate complex medical information and data
Ability to communicate effectively in a team environment
Ability to manage complex information with attention to detail and a high level of accuracy
Preferred
Experience with adult oncology patients
Experience coordinating clinical research studies
Knowledge of regulatory guidelines and procedures
Clinical Research Coordinator Certification (SOCRA or ACRP)
Experience working with Epic
Experience working with OnCore Clinical Trials Management System
Knowledge of University of Iowa policies, procedures and regulations
Benefits
Fringe benefit package including paid vacation; sick leave; health, dental, life and disability insurance options; and generous employer contributions into retirement plans
Company
University of Iowa Research
The Office of the Vice President for Research is committed to forging new frontiers of discovery by providing resources and support to researchers and innovators at the University of Iowa, to promote a culture of creativity that enriches the campus, the state, and the world.
1001-5000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase