Clinical Trials Coordinator & Regulatory Lead

DermCare Management; Florida; On-site; USD 55,000 - 75,000; Full time

Job summary

DermCare Management is seeking a Clinical Research Coordinator to lead and manage clinical trials in Florida, ensuring compliance with GCP and FDA regulations. You will collaborate with investigators, sponsors, and participants in a clinical office setting, emphasizing ethical research and data integrity.

The role involves coordinating visits, collecting samples, managing CRFs and data, handling investigational medications, and maintaining regulatory documentation.

Qualifications

• Must have previous experience conducting clinical trials and adherence to regulatory guidelines.
• Strong knowledge of GCP, FDA regulations, and HIPAA/ OSHA compliance.
• Bi-lingual Spanish is a plus.
• Proficient with clinical research databases and data entry.
• Phlebotomy experience where required.
• Excellent communication and interpersonal skills.
• Ability to work independently and as part of a team.
• Willingness to stay updated on clinical research trends and regulations.

Responsibilities

• Oversee execution of clinical trials under the PI and Site Manager.
• Conduct patient visits and collect specimens, perform ECGs and vital signs.
• Administer questionnaires and diaries per protocol.
• Schedule and coordinate visits and procedures, ensuring compliance.
• Maintain accurate case report forms and FDA compliance.
• Enter and manage trial data with confidentiality.
• Monitor participants and ensure ethical standards.
• Manage investigational medications including dispensing and accountability.
• Collaborate with laboratories to process and review reports.
• Recruit and screen study participants.
• Maintain regulatory documents up to date.
• Ensure supplies and equipment are available and functional.
• Comply with HIPAA, OSHA, and SOPs.

Skills

Clinical trial coordination

Regulatory compliance

Medical terminology

Data entry

Detail oriented

Organizational skills

Communication skills

Team collaboration

Spanish language

Education

High School Diploma or GED

Bachelor’s or Master’s degree (related field)

CCRC certification

Phlebotomy certification

Tools

Clinical trial databases

Electronic data capture (EDC)

Job description

DermCare Management is seeking a Clinical Research Coordinator to lead and manage clinical trials in Florida, ensuring compliance with GCP and FDA regulations. You will collaborate with investigators, sponsors, and participants in a clinical office setting, emphasizing ethical research and data integrity.

The role involves coordinating visits, collecting samples, managing CRFs and data, handling investigational medications, and maintaining regulatory documentation.