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 into electronic systems for clinical research protocols and laboratory investigations within the Holden Comprehensive Cancer Center (HCCC).

Requirements

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

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.
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, complying with Institutional Review Board requirements and responding to physician and research needs.
Assists in the design, development, execution, and administration of data gathering and data entry for clinical trials.
Communicates within the 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 screening, recruitment, and enrolling subjects; coordinates, randomizes, and schedules subject assessments and treatment as required by protocol.
Obtains informed consent; educates study participants on the scope of the study, schedule of assessments, and requirements of participation.
Enters subject data into electronic databases, ensuring all prerequisites are completed and within 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 a 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.
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 the 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 data is collected and entered into appropriate electronic records in a consistent and protocol-defined manner.
Reviews query reports and resolves all monitoring issues.
Supports the disease-specific team by providing backup 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 the 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.