Research Engineering/Scientist Associate III

The University of Texas at Austin•Austin, TX

7d•Onsite

About The Position

The Research Engineering/Scientist Associate III independently designs and conducts complex research projects, analyzes and presents data, and supervises junior research staff. The role develops research protocols, conducts literature searches, prepares grant applications, and contributes to research publications. It also supports human-subjects studies by identifying and screening participants, obtaining consent, enrolling participants, scheduling appointments, and conducting study procedures. The position coordinates multiple clinical research studies from start-up through close-out, overseeing participant recruitment and retention, study visits and assessments, specimen handling, data collection, regulatory submissions, study documentation, monitoring visits, and compliance activities. The associate develops and improves study workflows and procedures, manages timelines and operational issues, and collaborates with investigators, research teams, clinical sites, sponsors, institutional departments, and external partners. The role also creates training materials, mentors and trains research personnel, and participates in departmental and institutional research activities.

Requirements

Bachelor's degree in Biology, Chemistry, or Biochemistry.
Five years of relevant laboratory experience; relevant education and experience may be substituted as appropriate.

Nice To Haves

Master's degree.
At least seven years of laboratory experience, including experience with techniques used in the research area.
Fluency in Spanish.
Clinical Research Associate (CRA) certification from the Association of Clinical Research Professionals (ACRP) or similar certification.

Responsibilities

Identify, screen, recruit, and enroll eligible research participants in accordance with approved study protocols.
Develop, implement, and evaluate participant recruitment and retention strategies.
Obtain informed consent; schedule and conduct study visits; and administer study assessments and procedures.
Provide timely, professional communication and serve as a primary contact for research participants.
Coordinate human-subjects regulatory activities, including IRB submissions, amendments, continuing reviews, protocol deviations, biosafety documentation, and institutional compliance requirements.
Manage investigational medications and research devices according to study protocols and regulatory requirements.
Collect, process, store, and ship biological specimens, including blood collection when applicable, and perform protocol-required laboratory procedures.
Collect, verify, enter, maintain, and organize research data while ensuring accuracy, completeness, and integrity.
Prepare for and facilitate sponsor, regulatory, and internal monitoring visits; respond to findings and data queries; and implement corrective actions.
Identify, document, and report adverse events, protocol deviations, and other reportable events according to applicable requirements.
Manage day-to-day operations of multiple clinical research studies and ensure compliance with institutional policies, sponsor requirements, GCP, HIPAA, FDA regulations, and other applicable regulations.
Assist with study design and methods; develop data collection instruments; conduct surveys and chart abstraction; and maintain participant tracking systems.
Complete study start-up activities, obtain study materials, coordinate site initiation, and ensure required regulatory documentation is approved before activation.
Maintain complete, accurate, and audit-ready regulatory files, study documentation, source documents, and research records.
Prepare, review, and coordinate research-related agreements and submissions, including NDAs, MTAs, IRB submissions, contracts, project summaries, and progress reports.
Coordinate study close-out, regulatory closeout, record retention, and sponsor requirements.
Independently organize and manage multiple research projects, timelines, and competing deadlines.
Identify operational risks and project issues and implement appropriate solutions.
Develop, implement, and evaluate study workflows, SOPs, and processes to improve research quality, efficiency, regulatory compliance, and participant experience.
Coordinate research meetings, prepare agendas, document minutes, and monitor action items.
Collaborate with University departments, affiliated clinical sites, sponsors, external partners, principal investigators, research staff, clinical providers, regulatory agencies, and institutional partners.
Communicate research procedures, timelines, study requirements, and regulatory expectations clearly to participants and research stakeholders.
Use independent judgment to resolve operational issues and escalate complex problems appropriately.
Develop instructional materials, SOPs, and workflow documentation for study implementation and regulatory compliance.
Mentor, train, and guide research coordinators, assistants, students, trainees, investigators, and other research personnel.
Participate in departmental meetings, research initiatives, and institutional committees; serve as a liaison with the Office of Research and other institutional offices.