Research Support Specialist; N

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The University of Miami is currently seeking a Research Support Specialist to work at Soffer Clinical Research Center in Miami. The incumbent performs a variety of duties involved in the collection, compilation, and documentation of research data related to the assigned research studies. He or she also assists with the implementation of daily study activities and provides statistical support to these activities.

• Researches, collects, analyzes, and synthesizes data and maintains databases.
• Conducts quality assurance checks, reports on the status of research activities, and submits monthly activity logs for the protocol.
• Organizes and coordinates community working group meetings for protocol activities.
• Serves as the primary point of contact for community partners and supervises and oversees research data collection at protocol venues in the community.
• Reviews study progress, identifies areas of opportunity, and recommends solutions.
• Prepares and updates study research procedures manuals.
• Assists with the preparation of grant proposals by processing regulatory documents for all institutions and offices involved.
• Contributes to the publication and presentation of significant results and writes and edits material for publication and presentation.
• Maintains research files and responds to phone calls on the research study phone line.
• Adheres to University and unit-level policies and procedures and safeguards University assets.

• Enrolling new patients to participate in clinical research.
• Performs chart review/pre‑screening activities for study participant eligibility and coordination of simple clinical research protocols. Maintains enrollment procedures according to the protocol.
• Coordinates routine activities of clinical studies including data collection and maintenance, planning study timelines, scheduling appointments and study visits, meeting scheduling, and project evaluation.
• Performs moderate research tasks and adapts procedures for quality improvement under supervision.
• Understands and follows technical instructions for operating clinical research equipment, and problem‑solves when operational failures occur.
• Assists in observing and informing the PI/supervisor of adverse events, including those reported by study participants.
• Addresses adverse events per protocol, advocating for study participants and quality standards throughout the lifespan of the study.
• Identifies, reports, and helps solve problems in protocol deviations and unanticipated occurrences.
• Follows the appropriate fundamental requirements of all international, national, and local regulatory bodies.
• Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies.
• Prepares monthly progress reports and annual self‑evaluation of performance. Adheres to Department‑Specific policies and procedures and safeguards Department assets.

Education: Bachelor’s degree in a relevant field.

Certification and Licensing: CITI Program:
Human Subject Research, Group 1:
Biomedical Researchers (HSR), and Conflict of Interest (COI) preferred.

Experience: Minimum 2 Years of Relevant Experience.

The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.

The University of Miami is an Equal Opportunity Employer – Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law.  for additional information.