Clinical Research Coordinator II, Family and Community Medicine

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 No. 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!

WHY FAMILY MEDICINE?

The Department of Family and Community Medicine at UT Southwestern Medical Center is a cohesive group of clinicians, educators, and scholars who strive to deliver outstanding care to all patients, improve the way primary care is provided, and educate excellent family physicians for the next generation. The Department deeply values serving underserved patient populations throughout North Texas, and is committed to equity and social justice, supporting an inclusive community for work and learning.

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 Department of Family and Community Medicine at UT Southwestern seeks a Clinical Research Coordinator II to join our team. The person in this position will partner on research led by Dr. Rebecca Eary and Dr. Amy Hughes (MPIs) focused on testing randomized control trial aimed at improving transitions from an established pediatric survivorship program to an adult onco-primary care clinic (which provides primary and survivorship care) to test whether enhanced support and patient education from a nurse navigator will improve attendance of an adult survivorship clinic visit. The Clinical Research Coordinator II will also partner with investigators at UT Health Houston School of Public Health collaborating on this work, including Dr. Aubree Shay (MPI). The ideal candidate will have research experience in primary care, cancer, cancer survivorship/onco-primary care, and/or clinical research.

This position is a 100% grant-funded role.

ESSENTIAL FUNCTIONS
• Directly interacts with, and maintains records for, clinical research participants, remotely or in-person, such as:

o Coordinates and schedules procedures as per research study. A non-licensed coordinator may pend study order sets with oversight by PI.

o Recruits, screens, enrolls, consents, and follows research participants according to approved research protocols and applicable regulatory and institutional requirements.

o Conducts research procedures according to the protocol with proper training and check offs to maintain scope of service.

o Maintains required subject documentation for each study protocol.
• Assists in developing and implementing research studies, such as:

o Assists in developing website or other social media for marketing/recruiting for research studies.

o Reviews research study protocols to ensure feasibility requirements of the study.

o May assist in writing clinical research protocols.
• Coordinates and assists in regulatory and fiscal management and reporting duties, such as:

o Coordinates regulatory documentation for research studies, including maintaining information and submitting reports and paperwork to internal and external institutions, and other University and hospital offices to ensure study requirements are met.

o Prepares protocols for Institutional Review Board (IRB) submission, and may submit amendments and continuing review documents.

o Serves as primary liaison/lead in preparing annual reports for federal, state, and or/or local agencies on assigned studies.

o Identifies and documents protocol deviations, adverse events (AEs), serious adverse events (SAEs), and other reportable events and communicates and reports such events to the PI, IRB, study sponsor, and/or other applicable entities as required by the research protocol, institutional policies, or regulatory requirements.

o May assist the PI on the fiscal management of the trial including budget preparation.

o May perform research billing activities, as needed, based on size of department (including linking patient calendars).

o May assist with sponsor reporting, progress reports, study updates, and other sponsor-required documentation and deliverables.
• Conducts data collection activities, such as:

o Maintains and coordinates data collection information required for studies, including developing case report forms or data collection tools.

o Coordinates data management and collection for national (larger/more complex) research studies or multiple research studies at a given time.

o 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.

o Is responsible for research data collection and utilizes REDCap, Epic electronic medical record (EMR), and/or other electronic databases and data management systems, as required by the assigned research study.
• Performs study team communication, training, and administrative tasks in aid of study coordination, such as:

o Liaises between principal investigators, research team members, institutional offices, external collaborating institutions, sponsors, and other stakeholders to facilitate research activities and project coordination.

o May coordinate research activities across multiple departments, institutions, study sites, and external collaborating organizations.

o May supervise, train, orient, and provide guidance to learners, students, trainees, research coordinators, research assistants, and/or other study staff regarding research protocols, study procedures, data collection, and applicable regulatory requirements.

o May develop and maintain project timelines, study trackers, recruitment logs, data collection schedules, and other tools to monitor study progress and completion of project activities.

o May facilitate research team meetings, including coordinating meeting schedules, preparing agendas, documenting action items, and following up on assigned tasks.

o May assist with identifying and resolving operational issues, barriers to recruitment, data collection challenges, and other problems that may affect study progress or completion.

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.
• Performs other duties as assigned.

Salary Information
Salary is commensurate with education, skills, and relevant experience.

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.