Clinical Research Coordinator I, Internal Medicine

University of Texas Southwestern Medical Center; Dallas (TX); On-site; USD 55,000 - 75,000; Full time

Job summary

UT Southwestern Medical Center in Dallas seeks a Clinical Research Coordinator I to support multidisciplinary research projects under general supervision. Responsibilities include coordinating participant recruitment, screenings, consent, visits, and data management across multiple studies.

The role requires a Bachelor’s degree or higher in a medical or science field and at least one year of clinical research experience; preferred certifications may apply.

Qualifications

• Education: Bachelor’s degree or higher in medical or science related field.
• Experience: 1 year of clinical research experience; advanced degree may be considered.
• Regulatory documentation and SOPs experience is preferred.

Responsibilities

• Directly interacts with clinical research participants, via telephone, telehealth or in-person.
• Coordinate regulatory aspects of the trial to comply with FDA, institutional policies and SOPs.
• Schedule and coordinate study procedures per protocol; assist with consent when appropriate.
• Maintain and coordinate data collection, develop CRFs or data collection tools.
• Develop proficiency with the clinical trial management system and EMR.

Education

Bachelor’s Degree or higher in medical or science related field

1 year of clinical research experience

Tools

EPIC

CRFs

EDC systems

Job description

WHY UT SOUTHWESTERN?

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. Our highly competitive benefits package offers healthcare, PTO and paid holidays, on-site childcare, wage, merit increases and so much more. We invite you to be a part of the UT Southwestern team where you will discover a culture of teamwork, professionalism, and a rewarding career!

JOB SUMMARY

Works under the direction of an Investigator(s) with general supervision, to coordinate research projects. This position primarily performs patient/participant coordination, however, may conduct data management in smaller departments on as needed basis. Collects and ensures quality control of clinical or basic research data in support of multiple and/or complex research studies.

The Clinical Research Coordinator I will independently and collaboratively support a multidisciplinary research program by coordinating participant recruitment, screening, consenting, follow-up, and study visits; performing clinical procedures such as vital signs, EKGs, phlebotomy, and specimen processing/shipping; managing CRFs, EDC systems, EPIC documentation, and study records; and ensuring compliance with clinical research protocols, SOPs, GCP standards, IRB requirements, safety reporting, and regulatory documentation.

BENEFITS

UT Southwestern is proud to offer a competitive and comprehensive benefits package to eligible employees. Our benefits are designed to support your overall wellbeing, and include:

• PPO medical plan, available day one at no cost for full-time employee-only coverage
• 100% coverage for preventive healthcare-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
• Learn more about these and other UTSW employee benefits!

EXPERIENCE AND EDUCATION

Required

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

Preferred

• Licenses and Certifications (BLS) BASIC LIFE SUPPORT Licensure may be required based on research study protocols or affiliate location requirements. (CPRAED) CPR AED Licensure may be required based on research study protocols or affiliate location requirements. ACRP or SOCRA certification a plus

JOB DUTIES

• Directly interacts with clinical research participants, as required, for the research study. Interacts 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 which have order sets built may be pended by the non-licensed coordinator with oversight by PI.
• When outside of protocol, presents evidence and provides options (within scope of protocol) to PI.
• Screen, recruit, enroll and follow subjects according to protocol guidelines. May also assist with the consent process
• Maintain and coordinate data collection information required for each study which may also include developing CRF's or data collection tools
• Assist in developing and implementing research studies to include writing clinical research protocols.
• Conduct study procedures according to the protocol with proper training and check offs to maintain scope of work
• Requires familiarity with research budgets to assist with or develop study budgets. May perform research billing activities, as needed, based on size of department (including linking patient calendars).
• May review and abstract information from medical records for verification of eligibility for trials, as needed based on size of department.
• Monitors patient safety by reviewing records and ensuring appropriate reporting per protocol and HRPP standards.
• Review research study protocols to ensure feasibility
• Assist in developing website or other social media for marketing/recruiting of clinical research study
• Develop proficiency in the clinical trial management system, electronic medical record and other required data entry systems
• Maintain subject level documentation
• Duties performed may include one or more of the following core functions: a) Directly interacting with or caring for patients; b) Directly interacting with or caring for human-subjects research participants; c) Regularly maintaining, modifying, releasing or similarly affecting patient records (including patient financial records); or d) Regularly maintaining, modifying, releasing or similarly affecting human-subjects research records.
• Performs other duties as assigned.

SECURITY AND EEO STATEMENT

Security

This position is security-sensitive and subject to Texas Education Code 51.215, which authorizes UT Southwestern to obtain criminal history record information.

EEO

UT Southwestern Medical Center is committed to an educational and working environment that provides equal opportunity to all members of the University community. As an equal opportunity employer, UT Southwestern prohibits unlawful discrimination, including discrimination on the basis of race, color, religion, national origin, sex, sexual orientation, gender identity, gender expression, age, disability, genetic information, citizenship status, or veteran status.