Clinical Research Coordinator(Onsite)

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