Clinical Research Coordinator - Rare Disease Trials

Rare Disease Research, LLC; Atlanta (GA); On-site; USD 60,000 - 75,000; Full time

Benefits offered by this job

401(k)

401(k) matching

Health insurance

Paid time off

Vision insurance

Job summary

Rare Disease Research is seeking a Clinical Research Coordinator to support ongoing studies at our Atlanta site. The role involves coordinating visits, maintaining study documentation, and ensuring compliance with GCP and IRB requirements.

You will work closely with the Principal Investigator and study team, manage data entry, recruit participants, and participate in safety assessments. A minimum of two years in clinical research is required, with CRC experience preferred.

Qualifications

• Requires 2+ years in clinical research and prior CRC experience preferred.
• Must have GCP, IATA, ALCOAC training or equivalent.
• Willingness to work on-site at the Atlanta location.

Responsibilities

• Assists PI in protecting the rights and welfare of participants per federal regs and policies.
• Maintains study training documentation and materials.
• Collaborates with PI to address audits and implement recommendations.
• Reviews protocol details, timelines, inclusion/exclusion criteria, and privacy protections.
• Collects documents to initiate studies (e.g., FDA forms, CVs).
• Develops and executes recruitment strategies under HRPO/IRB approvals.
• Supports informed consent processes and ensures proper signatures and amendments.
• Screens subjects for eligibility and documents outcomes.
• Performs safety and efficacy assessments per protocol.
• Coordinates collection of vital signs, ECGs, blood draws, IP infusions.
• Ensures timely data entry and resolves data queries.
• Reports SAEs or protocol deviations to sponsor/IRB as required.
• Maintains source documentation and study binders with delegated staff.
• Monitors participants from start to end, escalating safety concerns as needed.
• Prepares data for interim visits and coordinates monitoring follow-ups.
• Communicates with sponsors, CROs, vendors promptly and professionally.
• Completes study documentation and maintains files per sponsor and university policies.
• Coordinates with departments to complete procedures during participant visits.
• Retains study records per sponsor requirements.

Education

Secondary degree in social science, health science or related field

LPN or Medical Assistant with CRC experience

Job description

Rare Disease Research is seeking a Clinical Research Coordinator to support ongoing studies at our Atlanta site. The role involves coordinating visits, maintaining study documentation, and ensuring compliance with GCP and IRB requirements.

You will work closely with the Principal Investigator and study team, manage data entry, recruit participants, and participate in safety assessments. A minimum of two years in clinical research is required, with CRC experience preferred.