Job Posting Title:
Research Engineering/Scientist Associate III ----
Hiring Department:
Department of Women's Health ----
Position Open To:
All Applicants ----
Weekly Scheduled Hours:
40 ----
FLSA Status:
Exempt from FLSA ----
Earliest Start Date:
Immediately ----
Position Duration:
Expected to Continue ----
Location:
AUSTIN, TX ----
Job Details:
PURPOSE
The Research Associate III independently designs and conducts complex research projects, analyzes and presents data, and supervises junior research staff. Th e Research Associate III is responsible for developing research protocols, performing literature searches, preparing grant applications, and contributing to research publications. In addition, the Research Associate III will identify and screen potential research participants, obtain consent, enroll participants, schedule appointments, and conduct all study procedures.
RESPONSIBILITIES
Participant Recruitment, Enrollment, and Data Collection
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 by providing professional, compassionate, and timely communication in person, by telephone, virtually, and through electronic correspondence.
Coordinate and complete specialized regulatory activities associated with human subjects research, including IRB submissions, amendments, continuing reviews, protocol deviations, biosafety documentation, and required institutional compliance activities.
Manage investigational medications and/or 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.
Clinical Research Operations and Regulatory Management
Coordinate and manage the day-to-day operations of multiple clinical research studies, ensuring compliance with institutional policies, sponsor requirements, Good Clinical Practice (GCP), HIPAA, FDA regulations, and other applicable federal, state, and local regulations governing human subjects research.
Perform clinical research activities, including assisting with study design, developing research methods and data collection instruments, conducting surveys, performing chart abstraction, maintaining participant tracking systems, and supporting regulatory compliance.
Complete study start-up activities, including obtaining study materials, coordinating site initiation activities, and ensuring regulatory documentation is complete and approved prior to 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 (e.g., NDAs, MTAs, IRB submissions, contracts, project summaries, progress reports, and related documentation) on behalf of principal investigators.
Coordinate study close-out activities, including regulatory closeout, record retention, and sponsor requirements.
Research Project Management
Develop, organize, prioritize, and independently manage multiple research projects, timelines, and competing…