Clinical Research Coordinator

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

A leading clinical research organization is seeking an experienced Clinical Research Coordinator (CRC) to join a well-established Phase I clinical research site in Miami, Florida.

This is an excellent opportunity for a CRC with Phase I clinical trial experience who enjoys working in a fast-paced, highly protocol-driven research environment. The site conducts early-phase clinical trials involving healthy volunteers as well as selected patient populations, providing exposure to an important stage of the drug development process.

Candidates outside of the Miami area are encouraged to apply, as relocation assistance and a sign-on bonus may be available.

Key Responsibilities

As a Clinical Research Coordinator, you will be responsible for the day-to-day coordination and execution of assigned clinical trials while working closely with Principal Investigators, site leadership, sponsors, and study participants.

Responsibilities include:

• Coordinate assigned clinical trials in accordance with study protocols, GCP, ICH guidelines, FDA regulations, and site SOPs
• Develop a thorough understanding of assigned study protocols and study-specific requirements
• Support study start-up activities, including reviewing protocols and preparing source documentation
• Screen and enroll potential study participants
• Conduct and document the informed consent process with prospective participants
• Schedule and coordinate study visits and protocol-required procedures
• Perform study-related activities as delegated by the Principal Investigator
• Maintain accurate, complete, and organized study documentation
• Enter study data into paper and electronic data capture systems
• Communicate with sponsors, laboratories, IRBs, and other regulatory organizations as appropriate
• Work closely with investigators and site leadership to ensure protocol compliance and participant safety
• Identify, document, and elevate protocol deviations or violations as required
• Accurately document and track adverse events in accordance with study protocols
• Support participant recruitment and enrollment initiatives
• Attend Investigator Meetings when required
• Assist with study close-out activities and appropriate storage of study records
• Contribute to SOP development and process improvements as needed

Qualifications

Required:

• Previous Phase I clinical trial experience
• Bilingual in Spanish and English
• Understanding of Good Clinical Practice (GCP), ICH guidelines, and clinical research regulatory requirements
• Strong understanding of clinical trial coordination and study documentation
• Excellent written, verbal, and interpersonal communication skills
• Ability to work independently while collaborating effectively with investigators, sponsors, study participants, and site teams
• Strong organizational skills and attention to detail
• Comfortable working in a fast-paced, protocol-driven clinical research environment
• Basic proficiency with Microsoft Word and Excel and familiarity with clinical research systems/EDC platforms

Education:

• High school diploma or equivalent required

Why Consider This Opportunity?

This position offers the opportunity to work at an established early-phase clinical research site with significant exposure to Phase I drug development. The environment provides hands-on experience with complex protocols and direct involvement in study execution and participant care.

The organization offers:

• $30–$35/hour
• Medical insurance
• Dental and vision insurance
• 401(k) with employer matching
• Paid time off
• Opportunities for professional growth within clinical research