University of Iowa Research · 6 days ago
Clinical Trials Research Associate - Cancer Center
Iowa City, Iowa, United States
Full-time
Onsite
Entry Level
1+ years expThe University of Iowa Research is seeking a Clinical Trials Research Associate for the Holden Comprehensive Cancer Center to coordinate clinical oncology study activities. The role involves planning, delivering, and evaluating health care for research protocol patients, while managing data entry and maintaining medical documentation.
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
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 needs and research requirements
Assists in the design, development, execution and administration of data gathering and data entry for clinical trials
Communicates within team and with external stakeholders to convey study specific objectives and requirements; develops communication tools as necessary
Assists in the operations of clinical research studies including the screening, recruitment, enrolling of subjects; coordinates, randomizes and schedules subject assessments and treatment as required by protocol
Obtains informed consent; educates study participants on the scope of study and schedule of assessments for clinical trials and requirements of participation
Enters subject data on electronic databases ensuring that all prerequisites have been completed and are within the required parameters
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
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 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 protocol
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 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
Coordinates ongoing research collaborations with outside institutions and study sponsors ensuring that data is collected and entered in appropriate electronic records in a consistent and protocol defined manner
Reviews query reports and resolves all monitoring issues
Supports the disease specific team through providing back up for follow up patients as needed
Participates in the development of general goals for the Clinical Trials Support Services; recommends changes to work practices and policies to achieve desired outcomes
Ensures time, energy, learning opportunities, and actions are focused on creating a safe, fair and respectful work environment and improving the workplace
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
Complies with University of Iowa policies and procedures
Maintains 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
Bachelors degree or an equivalent combination of education and experience
Minimum 1 year experience in a research setting
Experience with medical terminology
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