Clinical Research Assistant I, Emergency Medicine

About the role

Works under the direction of an Investigator(s) with general supervision, to primarily provide ongoing data management for local and national research studies. May coordinate observational (non-treatment) studies. The Clinical Research Assistant (Emergency Medicine) supports the conduct of clinical research studies within the Emergency Department by coordinating patient-facing and regulatory research activities.

Responsibilities

• Identify and screen potential study participants, recruit and obtain informed consent from eligible patients.
• Collect clinical and research data, perform study-related specimen collection including phlebotomy.
• Ensure accurate documentation of research procedures.
• Work closely with investigators, clinical staff, sponsors, and study participants to facilitate protocol adherence and high-quality data collection in a fast-paced acute care environment.
• Support regulatory compliance through the maintenance of study records, preparation of regulatory documents, and adherence to institutional, federal, and Good Clinical Practice (GCP) guidelines.
• Manage multiple research studies while maintaining participant safety, confidentiality, and data integrity.
• Enter data into case report forms or other data collection systems based on research study.
• Assist with maintenance of study-level documentation and data queries for accuracy.
• Compile data for regulatory requirements and/or deadlines for local or sponsor submissions.
• Maintain existing databases and ensure data integrity.
• Understand visit schedules, criteria, and protocol requirements for routine and low complexity trials; schedule research visits.
• Assist research staff by completing research protocol-related tasks.
• Assist with preparing annual reports and/or modifications to the Institutional Review Board (IRB), including reportable events (UPIRSO).
• Review and abstract information from medical records including eligibility criteria.
• Order and maintain research supplies following university/department procedures, ensuring equipment is in good working order.
• With adequate training and supervision, assist with collecting and processing specimens following established procedures/protocols.
• Assist in preparing studies for closeout, including packing files, documenting files for storage, and shipping extra supplies back to the sponsor.
• With adequate training/credentialing and supervision, perform study procedures such as phlebotomy, vital signs, and EKGs needed for research study.
• Duties may include one or more of the following core functions:
  • 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).
  • Regularly maintaining, modifying, releasing, or similarly affecting human-subjects research records.

Requirements

• High School Diploma or GED.

Preferred Qualifications

• BASIC LIFE SUPPORT (BLS) may be required based on research study protocols or affiliate location requirements.
• CPR AED 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 with 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.