Clinical Research Coordinator 2

University of Miami•Miami, FL

1d•Onsite

About The Position

The University of Miami/UHealth Department of Psychiatry has an exciting opportunity for a full time Clinical Research Coordinator 2 to work in Miami, FL. The Clinical Research Coordinator 2 serves as a mid-level clinical research professional that assists in the planning, coordinating, implementing, monitoring, and evaluating of specific clinical research studies. This role assists in the day-to-day operations of clinical research protocol implementation and carries out study coordination duties from protocol initiation to study close-out according to regulatory/sponsor guidelines. The incumbent works closely with study team members and other staff/faculty/study sites to ensure study participant safety and adherence to approved protocols, help with study-related administrative tasks, facilitate across-the-board flow of information, and coordinate study activities and personnel. Plays a key role in supporting the full scope of clinical trial operations. Responsibilities include assisting with participant recruitment, screening, and retention, and ensuring adherence to protocol requirements through study procedures, data collection, specimen handling, and drug accountability. Maintain regulatory binders and documentation, while also monitoring, reporting, and following up on adverse events, protocol deviations, and overall study progress. Facilitate communications with sponsors, monitors, and other institutions. Importantly, this CRC2 role will be dedicated to federally funded studies in areas such as cognitive impairment and schizophrenia, where accurate data collection, strict regulatory compliance, and careful participant oversight are essential to advancing the department’s research mission. This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.

Requirements

Bachelor’s degree in relevant field required
Minimum 2 years of relevant experience required
Learning Agility: Ability to learn new procedures, technologies, and protocols, and adapt to changing priorities and work demands.
Teamwork: Ability to work collaboratively with others and contribute to a team environment.
Technical Proficiency: Skilled in using office software, technology, and relevant computer applications.
Communication: Strong and clear written and verbal communication skills for interacting with colleagues and stakeholders.

Responsibilities

Assists in participant recruitment and retention activities and assists in screening potential study participants for eligibility.
Performs study procedures, routine tests, data collection/recording, and daily operations of moderate risk clinical research protocols.
Collects, processes, packs, and ships specimens according to protocol, applicable standards and regulations.
Maintains study binders and filings according to protocol requirements, UM and department policy.
Distributes study drug materials according to practice standards and clinical credentials as delegated by the Principal Investigator.
Monitors, documents, reports, and follows-up on study unanticipated/adverse events and protocol deviations.
Assists in implementing protocol amendments under direct supervision of the Principal Investigator.
Assists with study orientation and protocol related in-services to research team and clinical staff.
Monitors protocol implementation and study progress; keeps investigators fully apprised of study progress; submits progress reports according to established schedule.
Learns the research team and assists with communications/interactions with sponsor, data coordinating centers, compliance monitors, collaborators, investigators’ academic administrative personnel, and departments.
Assists in administrative tasks of study personnel including orientation, documenting core competencies, certification mandates, safety/responsible conduct of research education, and performance reviews.
Adheres to cultural competency guidelines; implements strategies to meet study participants’ needs for language translation, health literacy, etc.
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.
Adheres to University and unit-level policies and procedures and safeguards University assets.