Clinical Research Coordinator II - Trials & Data Expert

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

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;