Clinical Research Assistant I

UT Southwestern Medical Center • Dallas, TX

6h • Onsite

About The Position

Works under the direction of an Investigator(s) with general supervision, to primarily provide ongoing data management for local and national research studies. May coordinate observational (non-treatment) studies. The Clinical Research Assistant I (CRA I) will support the Ophthalmology Clinical Research Unit (CRU) in the conduct and coordination of ophthalmology-related clinical research. This entry-level position will provide support across departmental research studies, with primary responsibilities related to an ongoing tissue repository study and future biorepository initiatives. Responsibilities will include coordinating research activities and tissue collections, providing administrative and regulatory support, assisting with IRB submissions, and supporting clinical research coordinators with study-related activities. The position requires flexibility in work schedules to accommodate study-related tissue collections associated with operating room procedures. Additional responsibilities may include participant-facing research activities and phlebotomy when appropriately trained and certified, with opportunities for progressive involvement in the coordination and conduct of a broader range of ophthalmology clinical research studies as experience and skills develop. Duties may evolve based on the operational and research needs of the Ophthalmology CRU.

Requirements

• High School Diploma or GED

Nice To Haves

• Basic Life Support (BLS) certification may be required based on research study protocols or affiliate location requirements.
• CPR AED certification may be required based on affiliate location requirements.

Responsibilities

• Provide ongoing data management for local and national research studies.
• Coordinate observational (non-treatment) studies.
• Support the Ophthalmology Clinical Research Unit (CRU) in the conduct and coordination of ophthalmology-related clinical research.
• Coordinate research activities and tissue collections.
• Provide administrative and regulatory support.
• Assist with IRB submissions.
• Support clinical research coordinators with study-related activities.
• Perform participant-facing research activities and phlebotomy when appropriately trained and certified.
• Enter data into case report forms or other data collection systems based on research study.
• Assist with the maintenance of study-level documentation.
• Assist with data queries and possible edits for accuracy.
• Compile data for regulatory requirements and/or deadlines for local or sponsor submissions.
• Maintain existing databases and ensure data integrity.
• Understand visit schedules, criteria, and protocol requirements for routine and low complexity trials (e.g., questionnaire, data registry, scripted); schedule research visits.
• Assist research staff by completing research protocol-related tasks.
• Assist with preparing annual reports and/or modifications to institutional review board (IRB). This may include reportable events (UPIRSO).
• Review and abstract information from medical records including eligibility criteria.
• Recruit and enroll patients in research studies that may include consenting patients after training and with supervision.
• Assist with ordering and maintaining research supplies following university/department procedures, ensuring that equipment is in good working order.
• With adequate training and supervision, assist with collecting and processing specimens following established procedures/protocols.
• Assist in preparing studies for closeout (e.g., packing files, documenting files for storage, shipping extra supplies back to sponsor).
• With adequate training/credentialing and supervision, perform study procedures such as phlebotomy, vital signs, and EKG's needed for research study.
• Perform other duties as assigned.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED