Research Engineering/Scientist Associate III Full-time

Research Engineering/Scientist Associate III

The Research Associate III independently designs and conducts complex research projects, analyzes and presents data, and supervises junior research staff. The 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.

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 deadlines while ensuring successful study execution.
• Proactively identify operational risks and project-related issues and implement appropriate solutions.
• Develop, implement, and continuously evaluate study workflows, standard operating procedures (SOPs), and operational processes to improve research quality, efficiency, regulatory compliance, and the 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.

Communication and Collaboration

• 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 complex research procedures, timelines, study requirements, and regulatory expectations clearly to participants, investigators, sponsors, and research personnel.
• Exercise independent judgment in resolving operational issues and escalate complex problems appropriately.

Research Education, Training, and Departmental Support

• Develop instructional materials, standard operating procedures (SOPs), and workflow documentation to support research study implementation and regulatory compliance.
• 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.
• Actively 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.

Required Qualifications

• Bachelor's Degree in Biology, Chemistry, or Biochemistry
• 5 years of relevant laboratory experience.

Relevant education and experience may be substituted as appropriate.

Preferred Qualifications

• Master's Degree
• At least 7 year(s) of experience in laboratory experience, including experience with specific techniques used in the research area.
• Fluency in Spanish
• Certification as a Clinical Research Associate (CRA) from the Association of Clinical Research Professionals (ACRP) or similar certification.

Salary Range

$51,727+ depending on qualifications

Working Environment/Equipment

• Standard office equipment

• Repetitive use of a keyboard

Required Materials

• Resume/CV
• 3 work references with their contact information; at least one reference should be from a supervisor
• Letter of interest