Clinical Research Coordinator: Drive Trials & Compliance

Colonial Group; Spartanburg (SC); Hybrid; USD 45,000 - 65,000; Full time

Benefits offered by this job

401K/PTO/Vacation

Job summary

Colonial Group is seeking a Clinical Research Coordinator to support the Principal Investigator and Director of Clinical Research in daily trial activities. You will assist with regulatory submissions, patient enrollment, informed consent, data collection, and CRF completion.

The CRC will manage study files, coordinate with sponsors, ensure HIPAA compliance, and support IRB processes across multiple sites, with responsibilities including recruitment and site communications.

Qualifications

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Responsibilities

• Coordinate with Principal Investigator, department, and administration to ensure regulatory compliance and study activities.
• Assist the PI in feasibility assessments as requested.
• Review and comprehend the protocol.
• Attend investigator meetings as required or requested by the PI.
• Prepare IRB submissions and regulatory documents as required by the protocol.
• Prepare study materials including informed consent forms, source documents, enrollment logs and device accountability logs.
• Establish and organize study files and regulatory binders.
• Maintain protocol familiarity and study timelines.
• Provide training and tools for study staff and document training.
• Collect documents needed to initiate the study and submit to sponsor.
• Develop recruitment strategies in accordance with IRB requirements.
• Conduct informed consent process with participants and obtain signatures.
• Develop advertising materials for subject recruitment.
• Identify potential subjects and schedule visits.
• Screen subjects for eligibility using protocol criteria.
• Coordinate participant tests and sample collection per protocol.
• Collect data and perform assessments including vitals, EKGs, questionnaires and photos.
• Maintain enrollment logs and ensure timely CRF completion.
• Maintain inventory of study supplies and drug/device accountability.
• Complete study documentation and maintain files per sponsor requirements.
• Track enrollment status and document dropouts.
• Maintain records per sponsor requirements in regulatory binder.
• Communicate with sponsor, participants, and PI during the study.
• Assist PI in submission of closeout documents to agencies.

Skills

Regulatory compliance

IRB coordination

HIPAA compliance

Study coordination

Data collection

Informed consent

Recruitment strategies

Time management

Education

Bachelor's degree in a related field

SoCRA or ACRP certification

GCP training

Tools

EHR systems

Job description

Colonial Group is seeking a Clinical Research Coordinator to support the Principal Investigator and Director of Clinical Research in daily trial activities. You will assist with regulatory submissions, patient enrollment, informed consent, data collection, and CRF completion.

The CRC will manage study files, coordinate with sponsors, ensure HIPAA compliance, and support IRB processes across multiple sites, with responsibilities including recruitment and site communications.