Job Details

Join Metric Bio, a rapidly growing Clinical Site Network backed by private equity, as a Clinical Research Coordinator Specialist. We are looking for an organized and dedicated individual to manage and oversee clinical trials and research studies while ensuring compliance with all regulatory requirements and institutional policies.

Key Responsibilities:

• Lead daily clinical trial operations, ensuring adherence to study protocols, Good Clinical Practice (GCP), and regulatory guidelines.
• Recruit, screen, and enroll study participants; facilitate the informed consent process.
• Coordinate study visits, accurately collect and enter data into electronic databases or case report forms.
• Manage comprehensive study documentation, including regulatory binders, source documentation, and adverse event logs.
• Serve as the main communication conduit between study sponsors, monitors, investigators, and participants.
• Prepare for and engage in monitoring visits, audits, and regulatory inspections.
• Ensure the appropriate handling, storage, and accountability of investigational products.
• Maintain and update IRB submissions (initial, amendments, and continuing reviews).
• Educate participants on study protocols, associated risks, and potential benefits.
• Monitor study progress, enrollment, and data collection milestones effectively.
• Assist with budget preparation and ensure compliance with study billing processes as needed.

Qualifications:

Required:

• Bachelor's degree in a health or science-related field (Nursing, Public Health, Biology, etc.).
• Minimum of 12 years of experience in clinical research or a related healthcare environment.
• Solid understanding of clinical research regulations and GCP.
• Exceptional organizational and communication skills.
• Proficient in Microsoft Office and electronic data capture systems.

Preferred:

• Certification through ACRP (CCRC) or SOCRA (CCRP).
• Experience with IRB submissions and communications with sponsors.
• Familiarity with EPIC or similar electronic health record systems.

Working Conditions:

• Office and clinical environment.
• May require occasional evening or weekend hours based on study demands.
• Some travel for meetings or training may be necessary.