Clinical Research Coordinator 2

University of Miami•Miami, FL

6d•Onsite

About The Position

The University of Miami/UHealth Department of Psychiatry is hiring a full-time Clinical Research Coordinator 2 in Miami, Florida. The coordinator will report to the Department Chair and serve as the Clinical Coordinator for the Tics, OCD and Related Disorders Program at the UHealth Tourette Association of America (TAA) Center of Excellence. The role provides patient-facing, research, administrative, and clerical support, with direct training and supervision when assisting with patients. The coordinator will conduct patient phone calls and triage, maintain the Chair’s calendar, collect new-patient histories, perform supervised assessments, and refer eligible clinic patients to appropriate research studies and activities. The coordinator will organize community activities supporting the TAA Center of Excellence, including a speaker series and trainings. The role also assists the Department Chair with grant-submission documents and related work such as literature reviews, journal article submissions, chart reviews, data analysis, and PowerPoint and poster presentations. The coordinator works with the Chair’s Executive Assistant on coverage of clinical administrative matters. The position coordinates interventional and observational research projects, including participant recruitment, screening, assessments and follow-up, data collection and management using electronic data capture systems, communication with participants’ treatment teams, and participant reimbursements. The coordinator helps ensure studies follow their protocols, reports deviations, maintains regulatory and study records, and carries out regulatory-compliance activities such as IRB submissions and sponsor-required tasks. Study activities are conducted in accordance with applicable regulatory requirements and Good Clinical Practice.

Requirements

Bachelor’s degree in a relevant field.
At least 2 years of relevant experience.
Ability to learn new procedures, technologies, and protocols and adapt to changing priorities and work demands.
Ability to work collaboratively and contribute to a team environment.
Technical proficiency with office software, technology, and relevant computer applications.
Strong written and verbal communication skills.
Accuracy and attention to detail in completing assignments.
Ability to analyze, organize, and prioritize work under pressure while meeting deadlines.
Ability to handle confidential information with discretion.
Ability to work evenings, nights, and weekends as necessary.
Commitment to the University’s core values.
Ability to work independently and collaboratively.

Responsibilities

Conduct patient phone calls, triage patients, maintain the Department Chair’s calendar, and provide clerical and medical-related support for patient care and research.
Assist with patient care under direct training and supervision, including collecting new-patient histories and performing assessments under the Chair and other team specialists.
Refer eligible clinic patients to appropriate research studies and activities.
Organize community activities for the TAA Center of Excellence, including a speaker series and trainings.
Assist with grant-submission document preparation, literature reviews, journal submissions, chart reviews, data analysis, and PowerPoint and poster presentations.
Coordinate interventional and observational research projects and participant activities, including recruitment, screening, assessments, follow-up, data collection and management, treatment-team interactions, and reimbursements.
Ensure studies are conducted according to protocol, report protocol deviations, and maintain study files and regulatory documents in compliance with applicable requirements and Good Clinical Practice.
Perform regulatory-compliance activities, including IRB submissions and tasks required by study sponsors and other regulatory entities.
Assist with participant recruitment and retention and screen potential participants for study eligibility.
Perform study procedures, routine tests, data collection and recording, and daily operations for moderate-risk clinical research protocols.
Collect, process, pack, and ship specimens according to protocol, standards, and regulations.
Maintain study binders and files according to protocol requirements and University and department policies.
Distribute study drug materials according to practice standards and clinical credentials, as delegated by the Principal Investigator.
Monitor, document, report, and follow up on unanticipated or adverse events and protocol deviations.
Assist with protocol amendments under the Principal Investigator’s direct supervision.
Assist with study orientation and protocol-related in-services for research and clinical staff.
Monitor protocol implementation and study progress, keep investigators apprised, and submit progress reports on schedule.
Assist with communications and interactions with sponsors, data coordinating centers, compliance monitors, collaborators, investigators’ academic administrative personnel, and departments.
Assist with administrative tasks for study personnel, including orientation, core-competency documentation, certification mandates, safety and responsible-conduct-of-research education, and performance reviews.
Apply cultural-competency guidelines and strategies to meet participants’ language-translation and health-literacy needs.
Follow applicable international, national, and local regulatory requirements and maintain required safety, equality, responsible-conduct-of-research, continuing-education, and research-competency training.
Follow University and unit-level policies and procedures and safeguard University assets.
Work with the Chair’s Executive Assistant to cover Department clinical administrative matters.