Clinical Research Coordinator II: Study Coordination & Compliance

Socket.dev; Miami (FL); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Tuition remission

Job summary

The University of Miami Health System in Miami, FL is seeking a full-time Clinical Research Coordinator II to support planning, coordinating, and monitoring clinical studies from initiation to close-out. You will work with study teams, manage data collection, specimen handling, and regulatory compliance, while communicating with sponsors and sites to ensure participant safety and protocol adherence.

Qualifications include a Bachelor’s degree and at least two years of relevant experience;

Qualifications

• Bachelor’s degree in relevant field
• Minimum 2 years of relevant experience
• Skill in completing assignments accurately and with attention to detail
• Ability to analyze, organize and prioritize work under pressure while meeting deadlines
• Ability to process and 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/or in a collaborative environment

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

Skills

Bachelor’s degree

2+ years experience

Attention to detail

Time management

Confidential information handling

Evenings/weekends availability

Commitment to core values

Independent and collaborative work

Education

Bachelor’s degree in relevant field

Job description

The University of Miami Health System in Miami, FL is seeking a full-time Clinical Research Coordinator II to support planning, coordinating, and monitoring clinical studies from initiation to close-out. You will work with study teams, manage data collection, specimen handling, and regulatory compliance, while communicating with sponsors and sites to ensure participant safety and protocol adherence.

Qualifications include a Bachelor’s degree and at least two years of relevant experience;