Clinical Research Coordinator I

UT Southwestern Medical Center•Dallas, TX

About The Position

Works under the direction of one or more Investigators with general supervision to coordinate research projects. The position primarily coordinates patients and research participants, while potentially performing data management in smaller departments as needed. It collects and performs quality control on clinical or basic research data in support of multiple and/or complex studies. The coordinator interacts with participants by telephone, telehealth, or in person; coordinates trial regulatory activities and study procedures; screens, recruits, enrolls, and follows participants; and maintains study data and subject-level documentation. The role may also support protocol development, budgeting, research billing, medical-record review, participant safety monitoring, feasibility review, and study recruitment materials. Work is conducted in clinical and office settings.

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 and problem-solving skills.
Proactively work 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 depending on research study protocols or affiliate location requirements.
CPR AED (CPRAED) licensure may be required depending on research study protocols or affiliate location requirements.

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 accordance with industry standards, University policies, FDA requirements, and applicable hospital policies.
Coordinate and schedule study procedures according to the protocol; non-licensed coordinators may pend orders from approved protocol order sets under PI oversight.
When circumstances fall outside the protocol, present evidence and provide options to the PI within the scope of the protocol.
Screen, recruit, enroll, and follow research subjects according to protocol guidelines, and assist with the consent process as needed.
Maintain and coordinate study data collection information, including 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 the protocol after receiving appropriate training and check-offs.
Assist with or develop study budgets; perform research billing activities as needed, including linking patient calendars.
Review and abstract medical-record information to verify trial eligibility as needed.
Monitor patient safety by reviewing records and ensuring appropriate reporting under protocol and HRPP standards.
Review research protocols to assess feasibility.
Assist in developing websites or other social media for clinical study marketing and recruitment.
Develop proficiency in 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 from day one at no cost for full-time employee-only coverage.
100% coverage for preventive healthcare with no copay.
Paid Time Off available from 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.
On-site childcare.
Merit increases.