Clinical Research Coordinator I

UT Southwestern Medical Center•Dallas, TX

11d

About The Position

Works under the direction of an Investigator or Investigators with general supervision to coordinate research projects. The position primarily coordinates patients and participants, but may perform data management in smaller departments as needed. It collects and ensures the quality of clinical or basic research data in support of multiple and/or complex research studies. The coordinator interacts with research participants, coordinates regulatory and study activities, and maintains study data and documentation in accordance with protocols, applicable standards, and institutional requirements.

Requirements

Bachelor's degree or higher in a medical- or science-related field; additional years of experience may be considered in lieu of education.
One year of clinical research experience; an advanced degree may be considered in lieu of experience.

Nice To Haves

Basic Life Support (BLS) licensure may be required based on research study protocols or affiliate location requirements.
CPR AED licensure may be required based on research study protocols or affiliate location requirements.
ACRP or SOCRA certification is a plus.

Responsibilities

Interact directly with clinical research participants as required, by telephone, telehealth, or in person.
Coordinate trial regulatory activities and maintain or develop regulatory information in compliance with industry standards, University policies, FDA requirements, and other hospital policies.
Coordinate and schedule study procedures according to protocol.
When a situation falls outside the protocol, present evidence and provide options within the scope of the protocol to the principal investigator.
Screen, recruit, enroll, and follow subjects according to protocol guidelines; may assist with the consent process.
Maintain and coordinate study data collection information, which may include developing case report forms or other data collection tools.
Assist in developing and implementing research studies, including writing clinical research protocols.
Conduct study procedures according to protocol after receiving appropriate training and competency check-offs.
Use familiarity with research budgets to assist with or develop study budgets; may perform research billing activities as needed, including linking patient calendars.
May review and abstract medical record information to verify trial eligibility, depending on department needs.
Monitor patient safety by reviewing records and ensuring reporting complies with protocol and HRPP standards.
Review research protocols to assess feasibility.
Assist in developing websites or other social media for clinical research study marketing and recruitment.
Develop proficiency with the clinical trial management system, electronic medical record, and other required data-entry systems.
Maintain subject-level documentation.
Perform other duties as assigned.

Benefits

PPO medical plan available on day one at no cost for full-time employee-only coverage.
Preventive healthcare coverage at 100% with no copay.
Paid Time Off available on day one.
Retirement programs through the Teacher Retirement System of Texas (TRS).
Paid parental leave benefit.
Wellness programs.
Tuition reimbursement.
Public Service Loan Forgiveness (PSLF) qualified employer.
Paid holidays.
On-site childcare.
Wage and merit increases.