Clinical Research Coordinator (Onsite)

Position Summary:

The Research Coordinator is responsible for managing multiple clinical research protocols and acting as a liaison between investigators, sponsors, and internal teams. Under direct supervision, this role supports research operations and regulatory compliance while gaining foundational knowledge in human subject research.

Key Responsibilities:

• Adhere to the organization's Code of Conduct and Mission & Values.

• Complete all assigned training by designated deadlines.

• Support the operational activities of multiple ongoing research protocols.

• Serve as a liaison among site personnel, industry sponsors, and supervisors.

• Coordinate with departments including finance, hospital administration, and IRBs.

• Oversee assessment schedules from feasibility submission through study closeout.

• Review study design and inclusion/exclusion criteria with physicians and participants.

• Ensure patient protection and protocol compliance during informed consent processes.

• Review and maintain data accuracy through source document verification.

• Create study-specific source documentation tools when necessary.

• Enter and manage data in case report forms or electronic data capture systems.

• Track shipments of drugs, devices, and study supplies.

• Monitor and report adverse events, protocol deviations, and violations.

• Communicate study-related concerns to supervisors or designated personnel.

• Participate in study meetings, audits, and sponsor visits as required.

• Review and respond to findings from monitoring and auditing activities.

Education & Experience:

• Required:

  • Bachelor's degree

  • 1 years of relevant clinical research experience or equivalent education/experience

• Preferred:

  • Degree in healthcare, science, or a related field

  • Certified Clinical Research Coordinator (CCRC)

Knowledge, Skills & Abilities:

Knowledge:

• Familiarity with organizational SOPs and clinical research systems

• Emerging understanding of ICH guidelines and FDA regulations

• Basic knowledge of medical terminology

Skills:

• Strong communication and time management

• Proficient in data accuracy and documentation

• Basic clinical procedures (e.g., ECGs, phlebotomy, specimen handling/shipping)

Abilities:

• Strong interpersonal and collaborative skills

• Self-motivated with high attention to detail