Clinical Trials Research Associate - Cancer Center

About the role

The Holden Comprehensive Cancer Center at the University of Iowa is seeking a Clinical Trials Research Associate to serve as a member of the Clinical Trials Research team to coordinate clinical oncology study activities.

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.
• Maintains medical documentation, binders and files; manages 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.
• 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.
• Selects, applies and tests standard methodologies, techniques and tools such as manuals, forms and questionnaires.
• Reviews all query reports and resolves all monitoring issues.

Leadership

• 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.

Education & Compliance

• 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.
• Sets professional development opportunities.

Capacity

• Maintain primary coordination responsibilities of up to 5 studies actively recruiting patients.
• Able to enroll up to 16 new patients on trial in a calendar year.

Supervision

• Receives supervision from the Clinical Coordination Manager.
• Exercises supervision over new staff under direction.

University of Iowa Health Care Core Values

• Welcoming
• Excellence
• Collaboration
• Accountability
• Respect
• Empowerment

Department Information

• Located in Iowa City, IA
• Regular salaried position
• 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

Required Qualifications

• 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.

Desirable Qualifications

• 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.