Clinical Trials Research Associate - Cancer Center

The University of Iowa’s Holden Comprehensive Cancer Center is hiring a Clinical Trials Research Associate to coordinate clinical oncology study activities. The role supports patient care and study operations, including recruitment and enrollment, data collection and management, participant follow-up, and research compliance.

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

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

Adult Oncology Experience

Clinical Research Coordination

Regulatory Guidelines

Clinical Research Coordinator Certification SOCRA

Clinical Research Coordinator Certification ACRP

Epic

OnCore Clinical Trials Management System

Institutional Policies

Benefits

Paid vacation

Sick leave

Health, dental, life, and disability insurance options

Generous employer contributions into retirement plans

Company

Teaching hospital providing specialized medical care

Iowa City, Iowa, USA

https://uihc.org/

Founded in 1875

0-1 employees

Qualifications

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

This position is not eligible for University sponsorship for employment authorization

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

Required skills

Medical Terminology, Clinical Research Coordination, Adult Oncology, Regulatory Guidelines and Procedures, Clinical Research Coordinator Certification SOCRA, Clinical Research Coordinator Certification ACRP, Epic, OnCore Clinical Trials Management System, Clinical Data Management, Statistical Analysis

Preferred skills

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

1+ years