Clinical Research Coordinator II, Pediatrics Neurology

University of Texas Southwestern Medical Center; Dallas (TX); On-site; USD 60,000 - 80,000; Full time

Job summary

University of Texas Southwestern Medical Center in Dallas seeks a Clinical Research Coordinator II in the Department of Pediatrics, supporting the Neurology division. You will coordinate patient recruitment, consent, data collection, and regulatory management across multiple studies, under supervision of Investigators.

You may assist with budget, policy development, and data management in complex trials, collaborating with a multi-disciplinary team to ensure compliance and study success.

Qualifications

• Education: Bachelor's Degree in medical or science related field.
• Experience: 2 years clinical research experience.
• Preferred: CPR/CPRAED/ACRP or SOCRA certification is a plus.

Responsibilities

• Interact with clinical research participants via telephone, telehealth or in-person.
• Coordinate regulatory documentation for studies to comply with FDA, University policies and hospital policies.
• Schedule procedures per study protocol and assist with consent processes as needed.
• Screen, recruit, enroll and follow subjects according to protocol guidelines.
• Develop and maintain data collection tools and case report forms as required.
• Assist in developing research protocols and writing clinical research protocols.
• Monitor patient safety and ensure reporting per HRPP standards.
• May assist PI with fiscal management and budget preparation.
• Prepare IRB submissions and amendments; coordinate annual reports for regulators.

Education

Bachelor's Degree in medical or science related field

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'll discover a culture of teamwork, professionalism, and a rewarding career!

JOB SUMMARY

Works under the direction of an Investigator(s) with limited 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 CRC II in the Department of Pediatrics, supporting the division of Neurology, will support multiple projects funded by various study sponsors, both federal and industry funded. Primary duties will include patient recruitment, consenting, performing patient visits, data collection, data entry, query resolution and overall regulatory management. The CRC II will complete regulatory responsibilities such as IRB submissions and study registrations in el RB and the Clinical Trial Management System. Duties may also include assisting with fiscal management of trials, developing policies and procedures, and/or coordinating data management for complex research studies or preparing reports for federal, state or local agencies. This position will be part of a collaborative team environment and must be willing to support complex neurology clinical trials.

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 in medical or science related field
  

• Experience
  2 years years 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 may be required based on research study protocols or affiliate location requirements.
  (CPRAED) CPR AED 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 (non-clinical and clinical procedures). Interacts via telephone, telehealth or in-person.
• Coordinates regulatory documentation for research studies that includes maintaining information to comply with industry standards, University policies, FDA requirements or other hospital policies.
• Coordinates and schedules procedures as per research study. A non-licensed coordinator may pend study order sets with oversight by PI.
• Screens, recruits, enrolls and follows subjects according to research protocol guidelines (non-clinical and clinical procedures). May also assist with the consent processes.
• Maintains and coordinates data collection information required for each study that may also include developing CRF's (case report form) or data collection tools.
• Assists in developing and implementing research studies, may include writing clinical research protocols.
• Conducts research procedures according to the protocol with proper training and check offs to maintain scope of service.
• May assist the PI on the fiscal management of the trial including budget preparation.
• Monitors patient safety by reviewing records and ensuring appropriate reporting per protocol and HRPP standards.
• May perform research billing activities, as needed, based on size of department (including linking patient calendars).
• Coordinates data management and collection for national (larger/more complex) research studies or multiple research studies at a given time.
• Serves as primary liaison/lead in preparing annual reports for federal, state, and or/or local agencies on assigned studies.
• Prepares protocols for Institutional Review Board (IRB) submission. May also submit amendments and continuing review documents.
• Provides in-service training to all study team members and communicates to involved groups.
• Reviews research study protocols to ensure feasibility requirements of the study.
• Assists in developing website or other social media for marketing/recruiting based on assigned clinical research study.
• Enters data or assists in assembling data to enter in the assigned clinical trial management system, electronic medical record and/or other required data entry systems.
• Maintains required subject documentation for each study protocol.
• 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.
• 1. 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.