Clinical Research Coordinator II, Internal Medicine

UT Southwestern Medical Center; Dallas (TX); On-site; USD 60,000 - 75,000; Full time

Benefits offered by this job

PPO medical plan

100% preventive care coverage

Paid Time Off

TRS retirement programs

Paid parental leave

Wellness programs

Tuition reimbursement

PSLF qualified employer

Job summary

UT Southwestern Medical Center in Dallas seeks a Clinical Research Coordinator II to coordinate research projects under the supervision of Investigators within the CTU. Responsibilities include participant coordination, data management, and ensuring quality control across multiple studies in Internal Medicine divisions such as Cardiology and Hematology.

The role involves recruiting and consenting participants, regulatory documentation, and collaboration with the PI to ensure protocol adherence;

Qualifications

• Education: Bachelor’s Degree in medical or science related field
• Experience: 2 years years clinical research experience
• Preferred: Licenses and Certifications: BLS; CPR AED; ACRP or SOCRA; prior experience coordinating investigational drug or device trials

Responsibilities

• Directly interacts with clinical research participants, via telephone, telehealth or in-person as required.
• Coordinates regulatory documentation to comply with industry standards, University policies, FDA requirements.
• Coordinates and schedules procedures per study protocol; may pend study order sets with PI oversight.
• Screens, recruits, enrolls and follows subjects according to protocol; may assist with consent.
• Maintains and coordinates data collection information; may develop CRFs or data tools.
• Assists in developing and implementing research studies, including protocol writing.
• Conducts procedures per protocol with proper training and check-offs.
• May assist PI with trial fiscal management including budget prep.
• Monitors patient safety by reviewing records and reporting per HRPP standards.
• Coordinates data management for national/international studies or multiple studies.
• Prepares annual reports for federal/state/local agencies.
• Prepares IRB submission protocols and amendments; handles continuing reviews.
• Provides in-service training to study team and communicates effectively.

Skills

Communication

Data management

Regulatory coordination

IRB submissions knowledge

Education

Bachelor's Degree in medical or science related field

BLS Certification

CPR AED (CPRAED) certification

ACRP or SOCRA certification

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 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.

BENEFITS

• 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.
• Prior experience coordinating investigational drug or device clinical trials and/or industry sponsored clinical trials.

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 involve