Clinical Research Assistant II, Simmons Cancer Center

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. The Clinical Research Assistant II serves as a centralized clinical research data operations specialist, providing data management support for Cooperative Group and other federally funded clinical trials. This position is responsible for ensuring the timely, accurate, and complete entry of protocol-required data; resolving routine data queries; managing overdue data; and supporting audit and monitoring readiness in accordance with sponsor, institutional, and regulatory 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 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 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:
  • 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

• 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
• 2 years experience with High School Diploma or 1 year experience with Associate's Degree

Preferred Qualifications

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