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 seeks a Clinical Trials Research Associate to coordinate clinical oncology study activities as part of the Clinical Trials Research team. The role supports the planning, delivery, and evaluation of care for research protocol patients; works with Clinical Research Coordinators and multiple departments, including the University Clinical Trials Office; maintains medical documentation, binders, and files; and manages data entry and electronic data systems for clinical research protocols and laboratory investigations. The position supports clinical research studies from participant screening and enrollment through treatment, follow-up, and reporting. It maintains protocol-compliant records and databases, supports communication with patients, clinicians, study sponsors, and outside institutions, and helps ensure research data and patient care activities meet applicable institutional and study requirements. The role also contributes to team goals, a safe and respectful workplace, data evaluation, and professional development. The position is a regular salaried role located in Iowa City, Iowa, scheduled Monday through Friday, with hours generally worked between 7:00 a.m. and 5:00 p.m. It is supervised by the Clinical Coordination Manager. The role may provide functional or administrative supervision and may mentor new staff under direction. Capacity expectations include primary coordination responsibilities for up to five studies actively recruiting patients and the ability to enroll up to 16 new patients on trial in a calendar year.

Requirements

Bachelor's degree or an equivalent combination of education and experience.
At least one year of experience in a research setting.
Experience with medical terminology.
Excellent verbal, written, and interpersonal communication skills.
Proficiency 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.
Submit a resume and cover letter addressing the required and desired qualifications.
Successful candidates must self-disclose conviction history and undergo a criminal background check and credential and education verification.
Not eligible for University sponsorship for employment authorization.

Nice To Haves

Experience with adult oncology patients.
Experience coordinating clinical research studies.
Knowledge of regulatory guidelines and procedures.
Clinical Research Coordinator certification from SOCRA or ACRP.
Experience working with Epic.
Experience working with the OnCore Clinical Trials Management System.
Knowledge of University of Iowa policies, procedures, and regulations.

Responsibilities

Plan, deliver, and evaluate health care provided to research protocol patients as a member of the Clinical Research Services team.
Create, populate, maintain, and enhance databases containing clinical and research information from patient charts, samples, laboratory reports, and related sources, in compliance with Institutional Review Board requirements and physician and research needs.
Assist with the design, development, execution, and administration of clinical-trial data gathering and data entry.
Communicate study-specific objectives and requirements to team members and external stakeholders, and develop communication tools as needed.
Support clinical research study operations, including screening, recruitment, enrollment, coordination, randomization, and scheduling of subject assessments and treatment according to protocol.
Obtain informed consent and educate study participants about study scope, assessment schedules, and participation requirements.
Enter subject data into electronic databases after ensuring prerequisites are complete and within required parameters.
Follow study participants and manage data collection, including visit and interview records, adverse-event documentation, and medication-record review.
Provide documentation for physician review to help ensure patients are screened and treated according to protocol.
Monitor compliance and gather and maintain data for pharmaceutical-sponsored research, in-house trials, and cooperative group studies.
Create worksheets, treatment flow sheets, and other tools to support accurate source documentation of protocol treatment procedures.
Triage telephone calls from patients and families to facilitate clinic visits for medical or emergency care needs; assist in obtaining prescription medications; and ensure follow-up care aligns with protocol.
Liaise with local physicians and hospitals to facilitate care for protocol patients hospitalized outside the institution, obtain hospitalization documentation, and notify the Principal Investigator, study sponsor, and FDA as required by protocol.
Assist with periodic and special reports for IRB-01, the Protocol Review and Monitoring Committee, and other review committees; compile accrual data and review and summarize information for principal investigators and IRB-01.
Maintain protocol documentation, relevant data, follow-up correspondence, and summaries.
Coordinate ongoing research collaborations with outside institutions and sponsors, ensuring data is collected and entered consistently in appropriate electronic records and in accordance with protocol.
Review query reports and resolve monitoring issues.
Provide backup follow-up support for patients on the disease-specific team as needed.
Participate in developing general goals for Clinical Trials Support Services and recommend changes to work practices and policies to achieve desired outcomes.
Support a safe, fair, and respectful workplace and focus time, energy, learning opportunities, and actions on workplace improvement.
Assist in evaluating data validity, make recommendations, perform and interpret statistical analyses, prepare data for computer analysis, and use evaluation data to revise and implement changes in collaboration with the principal investigator.
Comply with University of Iowa policies and procedures and maintain knowledge of departmental standard operating procedures, ensuring practice aligns with them.
Attend protocol, University of Iowa Health Care, and study sponsor meetings and participate on committees as appropriate.
Seek professional development opportunities.
Maintain primary coordination responsibilities for up to five actively recruiting studies and be able to enroll up to 16 new patients on trial in a calendar year.