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. May support more complex studies under the direction of the principal investigator, Clinical Research Coordinator, and/or Clinical Research Lead. The role supports research activities including participant recruitment and enrollment, study documentation, data quality, regulatory submissions, and, with appropriate training and supervision, specimen collection and study procedures. The position works 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.
Ability to follow and understand 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.
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 assist with study-level documentation.
Assist with data queries and edits to ensure 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 relevant to the trial.
Assist with annual reports and modifications to the institutional review board, including reportable events.
Assist with preparing research records for sponsor or internal audits.
Recruit and enroll patients in research studies, including consenting patients after training and with supervision.
With adequate training and supervision, assist with participant screening and recruitment for more complex trials.
Conduct and document participant consent, and assist with developing 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, collect and process specimens according to established procedures and protocols.
Assist with study closeout, including packing and documenting files for storage and returning extra 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 skills under the direction of the PI and in accordance with the scope-of-work document.
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.
Merit increases.