Clinical Research Assistant II: Data, Recruitment & Consent

UT Southwestern Medical Center; Dallas (TX); On-site; USD 42,000 - 62,000; Full time

Benefits offered by this job

PPO medical plan

Paid Time Off

Retirement Programs

Paid Parental Leave

Wellness programs

Tuition Reimbursement

PSLF Qualified Employer

Job summary

UT Southwestern Medical Center in Dallas seeks a Clinical Research Assistant II to support data management for local and national studies. You will coordinate observational trials, assist with study protocols, and interact with clinical staff and patients in a fast-paced cancer center environment.

The role involves explaining the cancer center biorepository to patients, consenting participants, and assisting with regulatory documentation.

Qualifications

• Education High School Diploma or Associate's Degree in medical or science related field or Bachelor's Degree medical or science related field and no prior experience
• Experience 2 years experience with High School Diploma or 1 year experience with Associate's Degree
• Licenses and Certifications (BLS) BASIC LIFE SUPPORT may be required based on affiliate location requirements. (CPRAED) CPR AED may be required based on affiliate location requirements.

Responsibilities

• Understands visit schedules, criteria and protocol requirements for low complexity trials (e.g., questionnaire, data registry, scripted); schedules research visits.
• Assists research staff by completing research protocol related tasks.
• Reviews and abstracts information from medical records including eligibility criteria.
• 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.
• Performs QA/QC clinical analysis and data checks using various databases based on trial.
• Assists with preparing annual reports and/or modifications to institutional review board (IRB). This may include reportable events (UPIRSO).
• Assist and prepare research records for formal sponsor audits or internal audits.
• Recruits and enrolls patients in research study that may include consenting patients after training and with supervision.
• With adequate training and supervision, assists with participant screening and recruitment for more complex trials.
• Conducts and documents consent for participants in studies. Assists with the development of consent plans and documents for participants.
• Identifies incomplete, inaccurate, or missing data for more complex studies and works with lead coordinator to correct errors.
• 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 EKG's needed for research study. Based on research study, other procedures/equipment/services may be required.
• May perform patient care (basic skills) under the direction of PI following scope of work document.
• 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.

Education

High School Diploma or Associate's Degree in medical or science related field or Bachelor's Degree medical or science related field

Job description

UT Southwestern Medical Center in Dallas seeks a Clinical Research Assistant II to support data management for local and national studies. You will coordinate observational trials, assist with study protocols, and interact with clinical staff and patients in a fast-paced cancer center environment.

The role involves explaining the cancer center biorepository to patients, consenting participants, and assisting with regulatory documentation.