Phase I Clinical Research Coordinator - Miami Site

BioTalent; Miami (FL); On-site; USD 41,000 - 48,000; Full time

Benefits offered by this job

Medical insurance

Dental and vision insurance

401(k) with employer matching

Paid time off

Opportunities for professional growth

Job summary

BioTalent is seeking an experienced Clinical Research Coordinator to join a Phase I site in Miami, Florida. In this on-site role you will coordinate trials, screen and enroll participants, and ensure protocol compliance while working with investigators, sponsors, and study staff.

The ideal candidate has Phase I trial experience, is bilingual in Spanish and English, and understands GCP/ICH guidelines and regulatory requirements.

Qualifications

• Phase I clinical trial experience required.
• Bilingual in Spanish and English.
• Understanding of GCP, ICH guidelines, and regulatory requirements.
• Strong coordination and study documentation experience.
• Excellent written, verbal, and interpersonal communication skills.

Responsibilities

• Coordinate trials per study protocols, GCP, ICH, FDA regulations, and SOPs.
• Develop understanding of assigned protocols and site-specific requirements.
• Support start-up activities, review protocols, and prepare source documentation.
• Screen and enroll potential study participants.
• Conduct and document informed consent for participants.
• Schedule and coordinate visits and protocol-required procedures.
• Enter study data into paper and electronic systems.
• Maintain accurate study documentation for sponsors and IRBs.
• Communicate with sponsors, labs, and regulatory bodies as appropriate.
• Ensure protocol adherence and participant safety with investigators.

Skills

Phase I experience

Bilingual English/Spanish

GCP/ICH knowledge

Coordination & documentation

Independent yet collaborative

Education

High school diploma or equivalent

Tools

MS Word

MS Excel

EDC systems

Job description

BioTalent is seeking an experienced Clinical Research Coordinator to join a Phase I site in Miami, Florida. In this on-site role you will coordinate trials, screen and enroll participants, and ensure protocol compliance while working with investigators, sponsors, and study staff.

The ideal candidate has Phase I trial experience, is bilingual in Spanish and English, and understands GCP/ICH guidelines and regulatory requirements.