U

University of Texas at Austin

Public research university in Austin, TX

Research Engineering/Scientist Associate 3

Full-Time
$51.7k
Senior
Bachelor's, Master's
Austin, TX, USA
In Person
Biology & BiotechClinical Research Operations
Company Does Not Provide H1B Sponsorship

About the job

Requirements
  • A Bachelor's degree in Biology, Chemistry, or Biochemistry is required; relevant education and experience may be substituted as appropriate.
  • Five years of relevant laboratory experience is required.
Responsibilities
  • Independently design and conduct complex research projects, analyze and present data, develop research protocols, perform literature searches, prepare grant applications, and contribute to research publications.
  • Identify, screen, recruit, and enroll eligible research participants in accordance with approved study protocols.
  • Develop, implement, and evaluate participant recruitment and retention strategies to achieve enrollment goals.
  • Obtain informed consent, schedule study visits, conduct participant visits, and administer study assessments and research procedures.
  • Serve as the primary point of contact for research participants through in-person, telephone, virtual, and electronic communication.
  • Coordinate human-subjects regulatory activities, including institutional review board submissions, amendments, continuing reviews, protocol deviations, biosafety documentation, and institutional compliance activities.
  • Manage investigational medications and research devices in accordance with study protocols and regulatory requirements.
  • Collect, process, store, and ship biological specimens, including blood collection when applicable, and perform laboratory procedures according to protocol.
  • Collect, verify, enter, maintain, and organize research data to ensure accuracy, completeness, and data integrity.
  • Prepare for and facilitate sponsor, regulatory, and internal monitoring visits; respond to monitoring findings and data queries; and implement corrective actions as needed.
  • Identify, document, and report adverse events, protocol deviations, and other reportable events in accordance with study protocols, sponsor requirements, and regulatory guidelines.
  • Coordinate and manage day-to-day operations of multiple clinical research studies, ensuring compliance with institutional policies, sponsor requirements, Good Clinical Practice, HIPAA, FDA regulations, and other applicable regulations governing human-subjects research.
  • Assist with study design, develop research methods and data collection instruments, conduct surveys, perform chart abstraction, maintain participant tracking systems, and support regulatory compliance.
  • Complete study start-up activities, obtain study materials, coordinate site initiation activities, and ensure regulatory documentation is complete and approved before study activation.
  • Maintain complete, accurate, and audit-ready regulatory files, study documentation, source documents, and research records throughout the study lifecycle.
  • Prepare, review, and coordinate research-related agreements and submissions, including nondisclosure agreements, material transfer agreements, institutional review board submissions, contracts, project summaries, and progress reports, on behalf of principal investigators.
  • Coordinate study close-out activities, including regulatory closeout, record retention, and sponsor requirements.
  • Develop, organize, prioritize, and independently manage multiple research projects, timelines, and competing deadlines while ensuring successful study execution.
  • Identify operational risks and project-related issues and implement appropriate solutions.
  • Develop, implement, and evaluate study workflows, standard operating procedures, and operational processes to improve research quality, efficiency, regulatory compliance, and participant experience.
  • Coordinate research meetings, prepare agendas, document meeting minutes, and monitor completion of action items.
  • Collaborate with University departments, affiliated clinical sites, sponsors, and external partners to support successful project implementation.
  • Collaborate with principal investigators, research staff, clinical providers, sponsors, regulatory agencies, and institutional partners to ensure successful study implementation and execution.
  • Establish and maintain productive working relationships with multidisciplinary teams across the University and affiliated clinical sites.
  • Communicate research procedures, timelines, study requirements, and regulatory expectations to participants, investigators, sponsors, and research personnel.
  • Exercise independent judgment in resolving operational issues and escalate complex problems appropriately.
  • Develop instructional materials, standard operating procedures, and workflow documentation to support research study implementation and regulatory compliance.
  • Supervise junior research staff.
  • Mentor, train, and provide guidance to research coordinators, research assistants, students, trainees, investigators, and other research personnel on study procedures, regulatory requirements, institutional policies, and research best practices.
  • Participate in departmental meetings, research initiatives, and institutional committees.
  • Serve as a liaison with the Office of Research and other institutional offices while promoting adherence to current policies, procedures, and research resources.
Desired Qualifications
  • A Master's degree is preferred.
  • At least seven years of laboratory experience, including experience with specific techniques used in the research area, is preferred.
  • Fluency in Spanish is preferred.
  • Clinical Research Associate certification from the Association of Clinical Research Professionals or a similar certification is preferred.

About the company

U

University of Texas at Austin

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University of Texas at Austin is a public research university in Austin, Texas. It offers undergraduate, graduate, and professional education across a broad range of fields.

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