Social Science/Humanities Research Assistant III

Social Science/Humanities Research Assistant III

Requirements

• Bachelor’s Degree and at least four (4) years of experience executing clinical research studies, preferably inpatient drug treatment trials. Or master’s degree / RN with two (2) years of experience.
• Experience in IP accountability and compliance, obtaining informed consent, collecting vital signs, documenting adverse events, and maintaining regulatory binders.
• Strong ability to interact professionally with patients, families, and healthcare providers in emergency and ICU settings, demonstrating sound judgment, effective decision-making, and clear communication in confidential or urgent situations.
• Meticulous attention to detail and ability to adhere to study protocols, site policies, SOPs, regulatory requirements, and GCP guidelines.
• Able to work independently, displaying proactive problem-solving skills and high motivation.
• Effective project management skills with ability to plan, organize and prioritize work efficiently to meet deadlines.
• Proficiency in EDC, EHR/EMR, and CTMS platforms; Microsoft Office Suite; and willingness to learn other technologies as necessary.
• Must maintain a flexible work schedule to meet enrollment requirements and accommodate participant availability.
• Required to maintain site-specific clinical privileges at external partner locations, including receiving or providing proof of immunizations.

Responsibilities

• Execute clinical research protocols by enrolling trauma patients into time-sensitive clinical trials. Screen patients, explain study, obtain informed consent, and collaborate closely with study doctors to ensure subject eligibility. Coordinate baseline blood collections, patient randomization, and administration of IP.
• Communicate with study participants, schedule follow-up visits, perform investigational drug accountability, collect MRI and outcomes data, perform phlebotomy, collect vitals, process blood samples, collect and report adverse events to study doctors according to study protocol.
• Collect, document, and enter subject data on Case Report Forms (CRFs) and Electronic Data Capture (EDC) platforms. Extract medical data from electronic medical records. Resolve data queries, create notes to file, memos, and incident reports as needed.
• Maintain study regulatory binders and study files according to regulatory guidelines to ensure site readiness for audits and inspections. Participate in monitoring visits and respond to monitor requests and findings.
• Submit to IRB and OHRO for study start up, maintenance and close-out. Submit IRB reportable information according to protocol requirements and regulatory guidelines.
• Support the onboarding, training, supervision and mentorship of junior team members. Create training documentation.
• Assist with financial management of clinical trials, including tracking study awards, grants, contracts, account spending, invoicing, and budgets.
• Other related duties as assigned.

Preferred Qualifications

• RN or Master’s degree
• Three (3) years of experience executing clinical research studies
• Experience in neurology, neurosurgery, CNS, psychiatry and/or trauma therapeutic areas
• SOCRA or ACRP certification
• Phlebotomy experience & certification
• Fluency in Spanish
• Clinical or research experience in ED and ICU settings
• Experience conducting research at the University of Texas and/or Ascension Seton