Clinical Research Assistant II

About the Role

Works under the direction of an Investigator(s) with general supervision, to provide ongoing data management for local and national research studies and may coordinate observational (non-treatment/treatment) trials/studies. May provide a supporting role for more complex studies under the direction of the PI, Clinical Research Coordinator, and/or Clinical Research Lead.

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 systems based on the 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 the trial.
• Assists with preparing annual reports and/or modifications to the Institutional Review Board (IRB), including reportable events (UPIRSO).
• Prepares research records for formal sponsor audits or internal audits.
• Recruits and enrolls patients in research studies, which 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 the 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 and supervision, assists with collecting and processing specimens following established procedures/protocols.
• Assists 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, performs study procedures such as phlebotomy, vital signs, and EKGs needed for the research study.
• Based on the research study, other procedures/equipment/services may be required.
• May perform patient care (basic skills) under the direction of PI following the scope of work document. Duties may include:
  • Directly interacting with or caring for patients;
  • Directly interacting with or caring for human-subjects research participants;
  • Regularly maintaining, modifying, releasing, or similarly affecting patient records (including patient financial records); or
  • Regularly maintaining, modifying, releasing, or similarly affecting human-subjects research records.
• Performs other duties as assigned.

Requirements

• Education: High School Diploma or Associate's Degree in a medical or science-related field, or Bachelor's Degree in a medical or science-related field with no prior experience.
• Experience: 2 years of experience with a High School Diploma or 1 year of experience with an Associate's Degree.

Preferred Qualifications

• BASIC LIFE SUPPORT (BLS) certification may be required based on affiliate location requirements.
• CPR AED certification may be required based on affiliate location requirements.

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.

Work Details

Primary Location: Texas-Dallas-5323 Harry Hines Blvd

Schedule: Full-time, Day Shift