Clinical Research Coordinator I

UT Southwestern Medical Center • Dallas, TX

12h

About The Position

Works under the direction of one or more Investigators with general supervision to coordinate research projects. The position primarily involves coordinating patients and research participants, and may include data management in smaller departments as needed. Collects and ensures quality control of clinical or basic research data in support of multiple and/or complex research studies.

The role involves participant interaction and coordination across clinical research activities, including regulatory matters, study scheduling and procedures, recruitment and enrollment, data collection, safety monitoring, documentation, and use of clinical trial and medical record systems. Work may also include assisting with protocol development, study budgets, research billing, eligibility review, and study marketing, depending on study and department needs.

The position works in clinical and office settings. Salary is commensurate with education, skills, and relevant experience. This is a security-sensitive position subject to criminal history record review under Texas law.

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.
• Knowledge of basic and clinical research terminology, regulations, and procedures.
• Strong computer skills, including spreadsheets, databases, and interactive web-based software.
• Ability to communicate effectively with various levels of internal and external contacts.
• Ability to work with confidential information on a daily basis.
• Ability to follow and understand regulations for Protected Health Information (PHI).
• Good communication skills and ability to problem solve.
• Proactively works to maximize results for the team and organization.

Nice To Haves

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

Responsibilities

• Interact directly with clinical research participants by telephone, telehealth, or in person, as required by the study.
• Coordinate trial regulatory activities and maintain or develop regulatory information in accordance with industry standards, University policies, FDA requirements, and applicable hospital policies.
• Coordinate and schedule study procedures according to protocol; protocol order sets may be pended by a non-licensed coordinator with Principal Investigator oversight.
• When situations fall outside the protocol, present evidence and options within the scope of the protocol to the Principal Investigator.
• Screen, recruit, enroll, and follow subjects according to protocol guidelines, and assist with the consent process as needed.
• 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 appropriate training and competency checkoffs.
• Use familiarity with research budgets to assist with or develop study budgets; perform research billing activities as needed based on department size, including linking patient calendars.
• Review and abstract medical record information to verify trial eligibility as needed based on department size.
• Monitor patient safety by reviewing records and ensuring reporting in accordance with protocol and HRPP standards.
• Review research protocols to assess feasibility.
• Assist in developing websites or social media to market and recruit for clinical research studies.
• Develop proficiency with the clinical trial management system, electronic medical record, and other required data-entry systems.
• Maintain subject-level documentation.
• Perform other assigned duties.

Benefits

• PPO medical plan available on day one at no cost for full-time employee-only coverage.
• 100% coverage for preventive healthcare 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.
• Competitive benefits package including healthcare, PTO, paid holidays, on-site childcare, and merit increases.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level