Clinical Research Assistant II, HG-Lab McNutt

About the position

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 supporting role for more complex studies under the direction of the PI, Clinical Research Coordinator and/or Clinical Research Lead. Collect, process, and ship research clinical trial patient blood samples. Draws blood from adult and pediatric study patients. Maintain study subject consent files, IRBs, and enters data on subjects into database. Assist PI with IRB record keeping and obtaining informed consent from subject families; responds to study inquiries/audit info requests from trial sponsor on behalf of principal investigator. Phlebotomy certification required within 6 months of hire. Candidate must have own car to collect blood from offsite patients when needed. Mileage reimbursement provided.

Responsibilities

• Understands visit schedules, inclusion/exclusion criteria and protocol requirements for low complexity trials.
• 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).
• Assists and prepares 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.
• With adequate training and supervision, assists with collecting and processing specimens following established procedures/protocols.
• Assists in preparing studies for closeout.
• With adequate training/credentialing and supervision, performs study procedures such as phlebotomy, vital signs, and EKG's needed for research study.
• May perform patient care (basic skills) under the direction of PI following scope of work document.
• Performs other duties as assigned.

Requirements

• High School Diploma or Associate's Degree in medical or science related field or Bachelor's Degree in medical or science related field and no prior experience.
• 2 years experience with High School Diploma or 1 year experience with Associate's Degree.

Nice-to-haves

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