Job description

Clinical Research Coordinator II, Department of Internal Medicine – Clinical Trials Unit

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 one of the world’s foremost research institutions, UT Southwestern Medical Center is known for our life-changing research that has led us to 6 Nobel Prizes. With a Clinical Research career in our esteemed Internal Medicine Department, you will be a key part of our multidisciplinary research facility with opportunities to work with leaders in patient care and medical research. The Department of Internal Medicine Team at UT Southwestern is dedicated to providing exceptional patient-centered care. We seek to advance Internal Medicine through interprofessional education, leadership, and scientific discovery. 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

The Department of Internal Medicine is seeking a Clinical Research Coordinator II to join the Clinical Trials Unit (CTU). The formation of the CTU is an initiative led by the office of the Internal Medicine Department Chair. As a valued team member, you will work with clinical trials from various divisions within Internal Medicine including but not limited to Cardiology and Hematology and will manage key aspects of the unit's investigational drug and device clinical trials. This includes determining effective strategies for recruiting trial participants, screening, consenting, and enrolling participants, and overseeing data management. Currently the team’s research is focused on novel interventions in heart failure and cardiomyopathy. This position is eligible for a hybrid work schedule. If you enjoy challenging, fast-paced work and enjoy working with top medical leaders with an opportunity for growth this is the position for you.

Experience and Education

Minimum Requirements

Bachelor’s degree in medical or science related field and two years 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.

Experience with investigational drug and device clinical trials is preferred.

Job Duties

May perform some or all of the following based on research study:

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.

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.

Compliance with the COVID-19 vaccine mandate enforced by the Centers for Medicare and Medicaid (CMS) is a requirement for this position. Federal law requires individuals holding this position to be fully vaccinated or have an approved exemption for certain medical, disability, or religious reasons. Individuals who do not meet CMS vaccination requirements are not eligible and should not apply for this position but are encouraged to apply for other non-healthcare positions at UT Southwestern for which they qualify.

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

For general COVID-19 information, applicants should visit https://www.utsouthwestern.edu/covid-19/work-on-campus/

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. To learn more, please visit: why-work-here/diversity-inclusion.

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