Clinical Research Coordinator Lead, Pediatrics

Why UT Southwestern?

With over 75 years of excellence in Dallas-Fort Worth, Texas, UT Southwestern is committed to excellence, innovation, teamwork, and compassion. At UT Southwestern, we invest in you with opportunities for career growth and development that align with your future goals and help to provide security for you and your family. Our highly competitive benefits package offers healthcare, PTO and paid holidays, on-site childcare, wage, merit increases and so much more that are all available on the day you start work. UT Southwestern is honored to be a Veteran Friendly work environment that is home to approximately 800 veterans. We value your integrity, dedication, and the commitment you've made to our country. We're proud to support your next mission. Ranked by Forbes as one of the Top 10 National Employers, we invite you to be a part of the UT Southwestern team where you'll discover teamwork, professionalism, and consistent opportunities for growth.

Experience and Education

• Bachelors degree in medical or science related field and four years of clinical research experience. May consider additional years of experience or advanced degree in lieu of education or experience, respectively.
• ACRP or SOCRA certification a plus.
• A Heart Saver for non-licensure or BLS for Licensure may be required based on research study protocols or affiliate location requirements.
• Prior experience in the UTSW clinical research mentoring program is highly desirable, and participation in the UTSW clinical research mentoring program may count as additional experience.

Job Duties

May perform some or all the following:

• Maintains required subject documentation for each study protocol.
• 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 provide supervision to other members of the research team as necessary.
• May perform research billing activities, as needed, based on size of department (including linking patient calendars, monitors patient safety by reviewing records and ensuring appropriate reporting per protocol and HRPP standards.
• Assists PI/supervisor with daily activities of the research team and functions as a liaison between clinical research investigators and various organizations/departments and agencies including, but not limited to HRPP, FDA, Sponsored Programs, and affiliated hospitals.
• Coordinates data management and collection for national (larger/more complex) research studies.
• Serves as 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.
• Assists and monitors and/or maintain research study budgets.
• Assists the PI with the fiscal management of the trial.
• Ensures that the patient care charges are allocated appropriately for various research studies.
• 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 in the assigned clinical trial management system, electronic medical record and/or other required data entry systems.
• 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.

Knowledge, Skills & Abilities

• Work requires knowledge of basic and clinical research terminology, regulations, and procedures.
• Work requires strong computer skills (spreadsheets, databases, and interactive web-based software).
• Work requires ability to communicate effectively with various levels of internal and external contacts.
• Work requires ability to work with confidential information on daily basis
• Proactively works to maximize results of the team and organization
• Follows and understands the regulations for Protected Health Information (PHI)
• Work requires good communication skills.
• Work requires the ability to problem solve.

Working Conditions

• Work is performed primarily in an office environment but may require periodic visits to clinical and off-site clinical areas for purpose of interviewing patients.
• May require local or out-of-state travel based on research study.

To learn more about the benefits UT Southwestern offers visit https://www.utsouthwestern.edu/employees/hr-resources/

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