Clinical Research Assistant II

UT Southwestern Medical Center•Dallas, TX

About The Position

The Clinical Research Assistant II works under the direction of one or more investigators with general supervision, providing ongoing data management for local and national research studies and potentially coordinating observational or treatment trials. The role may also support more complex studies under the direction of the Principal Investigator, Clinical Research Coordinator, and/or Clinical Research Lead. This position assists with coordination of the Raynor Cerebellum Project, which investigates novel brain-stimulation therapeutics for individuals with cerebellar disorders. The assistant collaborates with research coordinators across Radiology, Neurosurgery, and Psychiatry. Key activities include coordinating, recruiting, screening, and scheduling participants; supporting experimental design and implementation; conducting behavioral studies; and collecting physiological data from patients with deep brain stimulator implants.

Requirements

High school diploma and 2 years of experience; or an associate's degree in a medical- or science-related field and 1 year of experience; or a bachelor's degree in a medical- or science-related field with no prior experience.
Knowledge of applicable federal and institutional regulations governing clinical research.
Knowledge of clinical research protocols.
Effective organizational skills and attention to detail.
Ability to work proactively to maximize team and organizational results.
Understanding of and compliance with regulations for Protected Health Information (PHI).
Strong computer skills, including spreadsheets, databases, and interactive web-based software.
Good communication skills.
Ability to problem solve.
Ability to conduct interviews with research subjects.

Nice To Haves

Basic Life Support (BLS) certification may be required based on affiliate location requirements.
CPR/AED certification may be required based on affiliate location requirements.

Responsibilities

Understand visit schedules, eligibility criteria, and protocol requirements for low-complexity trials, and schedule research visits.
Complete research protocol-related tasks to support research staff.
Review and abstract medical-record information, including eligibility criteria.
Enter study data into case report forms or other data-collection systems and help maintain study documentation.
Assist with data queries and edits to support accuracy.
Compile data for regulatory requirements and local or sponsor submission deadlines.
Maintain databases and ensure data integrity.
Perform quality assurance and quality control clinical analysis and data checks using trial-related databases.
Assist with annual reports and institutional review board modifications, including reportable events.
Prepare research records for sponsor or internal audits.
Recruit and enroll patients, including consenting patients after training and with supervision.
Assist with screening and recruitment for more complex trials with adequate training and supervision.
Conduct and document participant consent, and assist in developing consent plans and documents.
Identify incomplete, inaccurate, or missing data in complex studies and work with the lead coordinator to correct errors.
Order and maintain research supplies in accordance with university and department procedures, and ensure equipment is in good working order.
Assist with specimen collection and processing in accordance with established procedures and protocols, with adequate training and supervision.
Assist in preparing studies for closeout, including packing and documenting files for storage and returning extra supplies to sponsors.
Perform study procedures such as phlebotomy, vital signs, and EKGs when trained, credentialed, and supervised.
Perform basic patient care under the direction of the Principal Investigator when applicable and within the scope of work.
Coordinate, recruit, screen, and schedule participants for the Raynor Cerebellum Project.
Support experimental design and implementation, conduct behavioral studies, and collect physiological data from patients with deep brain stimulator implants.
Perform other duties as assigned.

Benefits

PPO medical plan, available on day one at no cost for full-time employee-only coverage
Preventive healthcare covered at 100% with no copay
Paid time off available on day one
Retirement programs through the Teacher Retirement System of Texas (TRS)
Paid parental leave
Wellness programs
Tuition reimbursement
Public Service Loan Forgiveness (PSLF) qualified employer
On-site childcare
Paid holidays
Healthcare benefits