Job Description

Position Summary:

The Research Coordinator is responsible for coordinating multiple clinical research protocols and serving as a liaison between investigators, sponsors, and internal stakeholders. Under direct supervision, the coordinator will develop a foundational understanding of research regulations and human subject research operations.

Key Responsibilities:

• Adhere to the organization's Code of Conduct and Mission & Value Statement.
• Complete all required training assignments by designated deadlines.
• Perform daily operational tasks for multiple research studies.
• Coordinate communications among site staff, sponsors, and supervisors.
• Work with departments including finance, hospital administrators, and IRB.
• Manage assessment schedules from feasibility through study closeout.
• Review study designs and eligibility criteria with physicians and participants.
• Ensure patient protection through proper informed consent and protocol compliance.
• Maintain accurate data via thorough source document review and entry.
• Create study-specific documentation tools when needed.
• Collect and enter data into case report forms and electronic systems.
• Track and manage drug, device, and supply shipments.
• Ensure timely, accurate data completion and documentation.
• Report and track adverse events, protocol deviations, waivers, and violations.
• Address protocol-related issues with study teams and management.
• Participate in investigator meetings, sponsor calls, and internal CRC meetings.
• Respond to monitoring and audit findings.

Education & Experience:

• Required: Bachelor's degree and at least 1 year of relevant experience.
• Preferred: Advanced degree or additional related experience.
• Equivalent combination of education and experience accepted.

Licenses & Certifications:

• Preferred: Certified Clinical Research Coordinator (CCRC).

Knowledge, Skills & Abilities:

Knowledge:

• Clinical research regulations (ICH, CFR).
• Organizational policies and procedures.
• Basic medical terminology.

Skills:

• Effective written and verbal communication.
• Strong organization and time management.
• Clinical procedures: ECG, phlebotomy, specimen processing and shipping.

Abilities:

• Strong interpersonal skills.
• Self-motivated and detail-oriented.

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