The University of Texas Southwestern Medical Center
Clinical Research Coordinator I, Pediatrics
The University of Texas Southwestern Medical Center, Dallas, Texas, United States, 75215
Clinical Research Coordinator I, Pediatrics (908579)
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 general supervision, to coordinate research projects. This position primarily performs patient/participant coordination, but may conduct data management in smaller departments as needed. Collects and ensures quality control of clinical or basic research data in support of multiple and/or complex research studies.
The Department of Pediatrics and Division of Critical Care Medicine is seeking a Research Coordinator to recruit patients, obtain informed consent, assist with regulatory documentation and perform clinical research projects within the ICU at Children’s Medical Center Dallas. An ideal candidate would have experience/familiarity with the environment within a critical care setting while also having experience in facilitating study development and implementation, assisting with patient recruitment, knowledge regarding regulatory requirements and data collection skills.
Key Responsibilities
Coordinate regulatory guidelines both internally and externally.
Monitor and maintain data quality and integrity.
Ensure adherence to internal and external deadlines.
Assist with monitoring and maintaining data quality and integrity.
Collaborate on day‑to‑day issues.
Assist with preparing scientific and regulatory information for national meetings and conferences.
Coordinate, communicate, and provide study‑related training to internal and external research staff.
Coordinate concierge travel services for research patients.
Consent and conduct study‑related procedures.
Ensure lab supplies are sent and received from external sites.
Ensure specimens received from external sites were properly shipped, stored properly, and managed following guidelines throughout the study.
Qualifications
Proven experience in clinical research.
Strong problem‑solving skills and a proactive team approach.
Ability to receive and integrate feedback from multiple collaborators and colleagues.
The ideal candidate will be an effective communicator with a strong track record in clinical research trials and a commitment to advancing our research objectives. Occasional weekends, evenings and travel may be required.
Benefits
PPO medical plan, available day one at no cost for full‑time employee‑only coverage.
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.
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.
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.
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.
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JOB SUMMARY Works under the direction of an Investigator(s) with general supervision, to coordinate research projects. This position primarily performs patient/participant coordination, but may conduct data management in smaller departments as needed. Collects and ensures quality control of clinical or basic research data in support of multiple and/or complex research studies.
The Department of Pediatrics and Division of Critical Care Medicine is seeking a Research Coordinator to recruit patients, obtain informed consent, assist with regulatory documentation and perform clinical research projects within the ICU at Children’s Medical Center Dallas. An ideal candidate would have experience/familiarity with the environment within a critical care setting while also having experience in facilitating study development and implementation, assisting with patient recruitment, knowledge regarding regulatory requirements and data collection skills.
Key Responsibilities
Coordinate regulatory guidelines both internally and externally.
Monitor and maintain data quality and integrity.
Ensure adherence to internal and external deadlines.
Assist with monitoring and maintaining data quality and integrity.
Collaborate on day‑to‑day issues.
Assist with preparing scientific and regulatory information for national meetings and conferences.
Coordinate, communicate, and provide study‑related training to internal and external research staff.
Coordinate concierge travel services for research patients.
Consent and conduct study‑related procedures.
Ensure lab supplies are sent and received from external sites.
Ensure specimens received from external sites were properly shipped, stored properly, and managed following guidelines throughout the study.
Qualifications
Proven experience in clinical research.
Strong problem‑solving skills and a proactive team approach.
Ability to receive and integrate feedback from multiple collaborators and colleagues.
The ideal candidate will be an effective communicator with a strong track record in clinical research trials and a commitment to advancing our research objectives. Occasional weekends, evenings and travel may be required.
Benefits
PPO medical plan, available day one at no cost for full‑time employee‑only coverage.
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.
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.
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.
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.
#J-18808-Ljbffr