Clinical Trials Research Associate - Cancer Center

UIOWA•Iowa City, IA

1d•Onsite

About The Position

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. This role involves assisting in the planning, delivery, and evaluation of health care for research protocol patients, working closely with Clinical Research Coordinators in data collection, and collaborating with multiple departments. The associate will maintain medical documentation, manage data entry, and utilize electronic data systems for clinical research protocols and laboratory investigations within the Holden Comprehensive Cancer Center (HCCC).

Requirements

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.

Nice To Haves

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

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 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 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.
Complies with UI policies and procedures.
Maintains knowledge of departmental SOPs; ensures 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.
Maintains 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.