Clinical Research Coordinator I, Simmons Cancer Center

With over 75 years of excellence in Dallas-Fort Worth, Texas, UT Southwestern is committed to excellence, innovation, teamwork, and compassion. As a world-renowned medical and research center, we strive to provide the best possible care, resources, and benefits for our valued employees. Ranked as the number 1 hospital in Dallas-Fort Worth according to U.S. News & World Report, we invest in you with opportunities for career growth and development to align with your future goals.

About the role

Works under the direction of an Investigator(s) with general supervision, to coordinate research projects. This position primarily performs patient/participant coordination but may also conduct 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.

Join UT Southwestern’s NCI-designated Simmons Cancer Center / Parkland Oncology Research team as a Clinical Research Coordinator. You will have the opportunity to work with top cancer specialists, participate in innovative therapies, cutting-edge research, and life-changing clinical trials. The role involves managing all patient activity on clinical oncology trials for the SCCC clinical trials at Parkland Hospital's Moody Outpatient Center Oncology, interfacing with physicians and patients seeking to participate in treatment trials for their cancer.

This position is hybrid but requires on-site presence at least 4 days a week, depending on clinic and research patient schedules.

Responsibilities

• Directly interact with clinical research participants via telephone, telehealth, or in-person.
• Coordinate regulatory aspects of the trial, including maintaining and developing regulatory information to comply with industry standards, University policies, FDA requirements, or other hospital policies.
• Coordinate and schedule study procedures as per protocol. Approved study protocols with built-in order sets may be pended by the non-licensed coordinator with oversight by the Principal Investigator (PI).
• When outside of protocol, present evidence and provide options (within the scope of the protocol) to the PI.
• Screen, recruit, enroll, and follow subjects according to protocol guidelines. Assist with the consent process.
• Maintain and coordinate data collection information required for each study, which may include developing Case Report Forms (CRFs) or data collection tools.
• Assist in developing and implementing research studies, including writing clinical research protocols.
• Conduct study procedures according to the protocol with proper training and check-offs to maintain scope of work.
• Assist with or develop study budgets, including familiarity with research budgets. Perform research billing activities as needed, including linking patient calendars.
• Review and abstract information from medical records for verification of eligibility for trials.
• Monitor patient safety by reviewing records and ensuring appropriate reporting per protocol and Human Research Protection Program (HRPP) standards.
• Review research study protocols to ensure feasibility.
• Assist in developing websites or other social media for marketing/recruiting of clinical research studies.
• Develop proficiency in the clinical trial management system, electronic medical record, and other required data entry systems.
• Maintain subject-level documentation.
• Perform duties that may include one or more of the following core functions:
  • Directly interacting with or caring for patients.
  • Directly interacting with or caring for human-subjects research participants.
  • Regularly maintaining, modifying, releasing, or similarly affecting patient records (including patient financial records).
  • Regularly maintaining, modifying, releasing, or similarly affecting human-subjects research records.
• Perform other duties as assigned.

Requirements

• Bachelor's Degree or higher in a medical or science-related field.
• 1 year of clinical research experience.
• May consider additional years of experience or an advanced degree in lieu of education or experience, respectively.

Preferred Qualifications

• 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.
• Familiarity with interviewing patients and obtaining informed consent.
• Experience with clinical trials, including protocol, eligibility criteria, schedule of activities, adverse events, and reporting of adverse events.

Benefits

• PPO medical plan, available day one at no cost for full-time employee-only coverage.
• 100% coverage for preventive healthcare with no copay.
• Paid Time Off, available 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.