Clinical Research Assistant II, Simmons Cancer Center

UT Southwestern Medical Center•Dallas, TX

About The Position

Works under the direction of one or more investigators with general supervision to provide ongoing data management for local and national research studies and may coordinate observational or treatment trials and studies. The role may provide support for more complex studies under the direction of the principal investigator, Clinical Research Coordinator, and/or Clinical Research Lead. The Clinical Research Assistant supports research visits, protocol-related tasks, medical-record review, data entry and quality checks, study documentation, regulatory submissions, participant screening and recruitment, and study closeout. With appropriate training, credentialing, and supervision, the position may also support specimen collection and processing, conduct consent activities, perform study procedures such as phlebotomy, vital signs, and EKGs, and provide basic patient care within the scope of work. The position is based in clinical and office settings. Salary is commensurate with education, skills, and relevant experience.

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 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 depending on affiliate location requirements.
CPR/AED certification may be required depending on affiliate location requirements.

Responsibilities

Understand visit schedules, eligibility criteria, and protocol requirements for low-complexity trials and schedule research visits.
Assist research staff with research protocol-related tasks.
Review and abstract medical-record information, including eligibility criteria.
Enter data into case report forms or other study 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 existing databases and ensure data integrity.
Perform clinical analysis and data checks for quality assurance and quality control using databases appropriate to the trial.
Assist with annual reports and institutional review board modifications, which may include reportable events (UPIRSO).
Help prepare research records for sponsor or internal audits.
Recruit and enroll patients in research studies; after training and with supervision, may consent patients.
With adequate training and supervision, assist with screening and recruiting participants for more complex trials.
Conduct and document participant consent and assist with development of consent plans and documents.
Identify incomplete, inaccurate, or missing data for more complex studies and work with the lead coordinator to correct errors.
Assist with ordering and maintaining research supplies according to university and department procedures, and ensure equipment is in good working order.
With adequate training and supervision, assist with specimen collection and processing according to established procedures and protocols.
Assist in study closeout, including packing files, documenting files for storage, and returning excess supplies to sponsors.
With adequate training, credentialing, and supervision, perform study procedures such as phlebotomy, vital signs, and EKGs; other procedures, equipment, or services may be required depending on the study.
May perform basic patient care under the direction of the principal investigator and within the scope of work.
Perform other duties as assigned.

Benefits

PPO medical plan, available on day one at no cost for full-time employee-only coverage.
100% coverage for preventive healthcare with no copay.
Paid time off available on 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.
On-site childcare.
Paid holidays.
Merit increases.