Clinical Research Coordinator

Job summary

The Clinical Research Coordinator will handle the day-to-day coordination of clinical studies, making sure each trial follows the approved protocol, Good Clinical Practice standards, institutional policies, and all relevant regulatory rules. This position supports participant recruitment, study recordkeeping, data capture, and overall trial execution while protecting participant safety and preserving data quality.

Key responsibilities

• Run and coordinate the daily activities for assigned clinical studies.
• Check study protocols and confirm that trial procedures match protocol requirements.
• Find, screen, and enroll participants who meet the inclusion and exclusion criteria.
• Explain the study and obtain documented informed consent before any procedures begin.
• Arrange participant appointments and coordinate assessments, procedures, and follow-up visits.
• Record study information accurately in Case Report Forms and Electronic Data Capture systems.
• Keep regulatory files, investigator site binders, and other study records complete and up to date.
• Watch for participant safety issues and document/report adverse events and serious adverse events within required timelines.
• Work closely with Principal Investigators, sponsors, CRO teams, laboratory staff, and other stakeholders.
• Support sponsor monitoring visits, audits, and regulatory inspections.
• Maintain compliance with GCP, institutional rules, and applicable local and international regulations.
• Track timelines, recruitment goals, and protocol milestones throughout the study.
• Help with study start-up, protocol amendments, close-out tasks, and document archiving.
• Protect participant confidentiality and keep research data secure at all times.

Requirements

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, Biotechnology, Medicine, or a related healthcare discipline.
• Previous exposure to clinical research or clinical trial coordination is preferred.
• GCP certification is considered an advantage.
• Solid understanding of clinical trial workflows and research ethics.
• Knowledge of ICH-GCP guidance and regulatory compliance requirements.
• Strong organization, prioritization, and time-management skills.
• Clear verbal and written communication skills.
• High attention to detail with accurate documentation habits.
• Comfort using Microsoft Office tools and EDC platforms.
• Ability to work both independently and as part of a multidisciplinary team.
• Good problem-solving ability and interpersonal skills.

Working conditions

This role is usually carried out in hospitals, research institutions, academic medical centers, or clinical research organizations. Flexibility may be needed to align with participant availability and sponsor visits.

Additional information

The position is based in Boston, MA and is a full-time onsite role.