Clinical Research Coordinator-256633

Medix™; DeLand (FL); On-site; USD 55,000 - 75,000; Full time

Job summary

Medix seeks a Clinical Research Coordinator to ensure execution of assigned trials in compliance with GCP, ICH, HIPAA, FDA regulations, and SOPs. You will work independently while practicing ALCOA and safeguarding participant confidentiality.

Responsibilities include screening and consenting subjects, scheduling visits, collecting vital signs and lab samples, performing record-keeping, EDC data entry, and timely reporting of SAEs and deviations to sponsors and IRBs.

Qualifications

• In addition to clinical knowledge, candidates should have 1+ years of clinical research or clinical experience.
• Basic clinical skills such as blood pressure, vitals, EKGs, and phlebotomy are preferred.
• Proficiency with MS Office, email, EHR, and web applications is expected.

Responsibilities

• Screen and consent subjects; schedule visits; reminders and follow-ups; collect vitals/ECGs; perform phlebotomy and lab tasks.
• Document in source charts; update source files; perform EDC data entry and query resolution; manage logs and supplies.
• Complete start-up tasks; attend SIVs/IMs; handle study tech; host monitoring visits; report SAEs/ Deviations.
• Assist with recruitment and maintain positive team/client communication.

Skills

Blood pressure

Vitals

EKGs

Phlebotomy

MS Office

Email

EHR

Web applications

Education

MA diploma, LPN/LVN, EMT credential, or Associate’s degree

Tools

MS Office

Email

EHR

Web applications

Job description

The Clinical Research Coordinator will ensure execution of assigned clinical trials in compliance with GCP, ICH, HIPAA, FDA regulations, and company SOPs. Operates independently while practicing ALCOA principles, maintaining strict confidentiality, and upholding high integrity.

Key Responsibilities

• Screen and consent subjects; conduct visit scheduling, appointment reminders, and follow-ups; collect vital signs/ECGs; perform lab procedures (phlebotomy, centrifuging, specimen storage/shipping/accountability, and courier notification).
• Document in source clinic charts; build/update source files; perform EDC data entry and query resolution; update logs and chart filings; maintain and order study supplies; request/track medical records.
• Complete start-up tasks (training, ISF filing); prepare for and attend SIVs and Investigator Meetings (IMs); set up and maintain study technology; host monitoring visits and resolve issues; ensure investigator review of lab/patient results; file SAEs/Deviations to Sponsor and IRB; report adverse events and non-compliance promptly.
• Assist with recruitment and tracking; maintain positive communication with team members and clients; perform other duties as assigned.

Qualifications & Skills

• MA diploma, LPN/LVN, EMT credential, or Associate’s degree and 1+ years of clinical research or clinical experience (or an equivalent combination).
• Preferred proficiency in basic clinical skills (blood pressure, vitals, EKGs, phlebotomy).
• Computer proficiency (MS Office, email, EHR, web applications)