Clinical Research Coordinator- 256633

Medix™; DeLand (FL); On-site; USD 42,000 - 64,000; Full time

Job summary

Medix™ is seeking a Clinical Research Coordinator to support the execution of assigned clinical studies at a DeLand site. You will screen and pre-qualify potential participants, obtain informed consent, coordinate follow-up visits, and maintain accurate source documentation, entering data into EDC systems and responding to data queries.

You will also collect vitals, ECGs, and other protocol-required assessments, perform basic lab procedures as permitted, and coordinate medical record requests

Qualifications

• Responsibilities listed in job ad.

Responsibilities

• Screening and pre-qualifying potential study participants.
• Obtaining informed consent from eligible participants.
• Coordinating and conducting patient follow-up visits.
• Maintaining accurate and complete source documentation.
• Entering clinical data into EDC systems and responding to data queries.
• Obtaining vital signs, ECGs, and other protocol-required assessments.
• Performing basic laboratory procedures as permitted by the study protocol.
• Coordinating medical record requests and maintaining documentation.
• Maintaining study logs, regulatory files, and participant records.
• Ordering, organizing, and tracking study-specific supplies.
• Scheduling participant visits and conducting appointment reminders.
• Developing and maintaining source documentation as required by protocols.
• Supporting monitoring visits and addressing follow-up items in a timely manner.
• Ensuring review of laboratory results and patient information by the investigator.
• Preparing and submitting safety reports and deviations to sponsors/IRB.
• Documenting and reporting adverse events per study requirements.
• Escalating non-compliance or protocol issues to appropriate team members.
• Maintaining confidentiality of participant and organizational information.
• Assisting with study start-up activities and site initiation visits.
• Setting up and maintaining study-specific technology and systems.

Job description

Working collaboratively with the clinical research site team, the CRC will support the execution of assigned clinical studies. Responsibilities may include:

• Screening and pre-qualifying potential study participants
• Obtaining informed consent from eligible participants
• Coordinating and conducting patient follow-up visits
• Maintaining accurate and complete source documentation
• Entering clinical data into electronic data capture (EDC) systems and responding to data queries
• Obtaining vital signs, ECGs, and other protocol-required assessments
• Performing basic laboratory procedures as permitted by the study protocol, including blood collection, centrifugation, specimen processing, storage, shipment, and reconciliation
• Coordinating medical record requests and maintaining appropriate documentation
• Maintaining study logs, regulatory files, and participant records
• Ordering, organizing, and tracking study-specific supplies
• Scheduling participant visits and conducting appointment reminders
• Developing and maintaining source documentation as required by individual protocols
• Supporting monitoring visits and addressing follow-up items in a timely manner
• Ensuring study reports, laboratory results, and other patient information are reviewed by the investigator as required
• Preparing and submitting safety reports, protocol deviations, and other required documentation to sponsors and/or the IRB
• Documenting and reporting adverse events in accordance with study requirements
• Escalating potential non-compliance or protocol issues to appropriate team members
• Maintaining professional and effective communication with study participants, internal teams, investigators, and external partners
• Following ALCOAC principles and applicable documentation standards
• Assisting with participant recruitment, enrollment, retention, and study tracking
• Maintaining confidentiality of participant, client, and organizational information
• Supporting study start-up activities, including completion of required training and maintenance of study documentation
• Assisting with preparation for and participation in site initiation visits and investigator meetings
• Setting up, maintaining, and supporting study-specific technology and systems as needed
• Performing other duties and responsibilities as assigned