Job Description

Position Overview

We are seeking experienced clinical research professionals to support two part-time contract assignments. One role focuses on chart review, phone screening, participant recruitment, and clinical trial coordination. The second focuses on ongoing study visits, data management, regulatory documentation, and closeout activities for a clinical trial that has completed recruitment.

Both positions require strong organizational skills, attention to detail, and the ability to maintain accurate documentation in accordance with study protocols, FDA regulations, ICH guidelines, and Good Clinical Practice (GCP) requirements.

Assignment 1: Clinical Research Coordinator – Chart Review & Phone Screening

Schedule: 24 hours per week, Monday–Friday between 8:00 AM and 5:00 PM. No evenings or weekends.

Duration: 4-month contract

Work Arrangement: Onsite

Responsibilities

• Conduct chart reviews and phone screenings to identify and assess potential clinical trial participants.
• Recruit, prescreen, and evaluate participants for study eligibility in accordance with protocol requirements.
• Coordinate participant scheduling and study activities from screening through follow-up.
• Collect, verify, organize, and maintain accurate clinical data and source documentation.
• Perform data entry, electronic data capture (EDC) updates, query resolution, and data reconciliation.
• Maintain study documentation and support regulatory submissions and IRB requirements as needed.
• Collaborate with research staff, sponsors, and CRO representatives to support study execution.
• Assist with study startup activities, site feasibility assessments, initiation visits, and research meetings as applicable.
• Support financial payment processing, safety data reconciliation, and study closeout activities as assigned.
• Ensure study activities comply with applicable regulatory requirements, GCP guidelines, and study protocols.

Qualifications

• Previous clinical research experience, particularly in participant recruitment and screening.
• Experience with chart review, phone screening, or patient prescreening.
• Familiarity with clinical trial protocols, source documentation, and electronic data capture systems.
• Knowledge of GCP requirements, FDA regulations, and IRB documentation.
• Strong communication, organization, and documentation skills.

Assignment 2: Study Coordinator – Summerville, SC

Schedule: Approximately one onsite day per month, coordinated around scheduled participant visits. Some flexibility may be necessary if appointments change.

Duration: Up to 6 months of currently approved support, with the possibility that study activities may continue beyond the contract period.

Work Arrangement: Onsite

Responsibilities

• Prepare for and support scheduled clinical study visits for one remaining participant in a study that has closed to recruitment.
• Complete visit-related source documentation and maintain accurate study records.
• Perform outstanding data entry, resolve queries, and assist with data verification and cleanup.
• Maintain regulatory documentation and assist with applicable IRB submissions and approvals.
• Ensure study documentation and data remain accurate, complete, and compliant with protocol requirements.
• Coordinate with the research team regarding upcoming visits, database deadlines, and study milestones.
• Assist with ongoing study maintenance and closeout activities as the trial winds down.

Qualifications

• Previous experience as a Clinical Research Coordinator, Study Coordinator, or in a similar clinical research role.
• Familiarity with clinical study visits, source documentation, and regulatory records.
• Experience with EDC systems, data entry, query resolution, and data verification.
• Knowledge of GCP guidelines and IRB requirements.
• Strong attention to detail and the ability to work independently.

Additional Information

These are separate, project-based contract opportunities with limited weekly hours. Candidates must be comfortable with the onsite requirements, schedules, and assignment durations outlined for their respective roles.

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