Clinical Research Associate I

The University of Texas Southwestern Medical Center; Dallas (TX); On-site; USD 42,000 - 65,000; Full time

Job summary

The University of Texas Southwestern Medical Center in Dallas seeks a data management specialist to support local and national research studies. You will enter data into case report forms and data collection systems, maintain study documentation, and assist with data queries and regulatory submissions.

With supervision, you will recruit and enroll patients, help prepare annual reports, and support IRB modifications.

Qualifications

• Enters data into case report forms or other data collection system.
• Maintains study documentation and handles data queries.
• Recruits and enrolls patients in research studies.
• Assists with IRB modifications and regulatory submissions.
• Performs phlebotomy, vital signs, and EKGs as needed.
• Ensures data integrity and supports closeout activities.

Responsibilities

• Enters data into case report forms or other data collection system based on research study. Assists with maintenance of study level documentation.
• Assists with data queries and possible edits for accuracy.
• Compiles data for regulatory requirements and /or deadlines for local or sponsor submissions.
• Maintains existing databases and ensures data integrity.
• Understands visit schedules, criteria and protocol requirements for routine and low complexity trials (e.g., questionnaire, data registry, scripted); schedules research visits.
• Assists research staff by completing research protocol related tasks.
• Assists with preparing annual reports and/or modifications to institutional review board (IRB). This may include reportable events (UPIRSO).
• Reviews and abstracts information from medical records including eligibility criteria.
• Recruits and enrolls patients in research study that may include consenting patients after training and with supervision.
• Assists with ordering and maintaining research supplies following university/department procedures, ensuring that equipment is in good working order.
• With adequate training/credentialing and supervision, performs study procedures such as phlebotomy, vital signs, and EKGs needed for research study. Based on research study, other procedures/equipment/services may be required.
• 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.

Skills

Data management

Clinical research

IRB knowledge

Phlebotomy

Data entry

Regulatory compliance

Job description

The University of Texas Southwestern Medical Center in Dallas seeks a data management specialist to support local and national research studies. You will enter data into case report forms and data collection systems, maintain study documentation, and assist with data queries and regulatory submissions.

With supervision, you will recruit and enroll patients, help prepare annual reports, and support IRB modifications.