Research Support Specialist (N)

University of Miami•Miami, FL

30d•Onsite

About The Position

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/she also assists with the implementation of daily study activities and provides statistical support to these activities. Department Specific Functions The Research Support Specialist serves as an entry-level clinical research professional who has a basic foundation in clinical research through assigned responsibilities in patient screening and enrollment, data management, and implementing research protocols. This role exhibits increased learned skills and flexibility in performing duties and assumes responsibility for scientific and research support.

Requirements

Bachelor’s degree in relevant field
Minimum 2 years of relevant experience

Nice To Haves

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

Responsibilities

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 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-solving 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.
Prepare monthly progress reports and annual self-evaluation of performance. Adheres to Department-Specific policies and procedures and safeguards Department assets.