Summary

Job Duties

Participant Recruitment, Screening, Enrollment & Scheduling - 30%

• Recruits, screens, enrolls, consents, and schedules study participants.
• Conducts participant outreach and eligibility assessments.
• Ensures informed consent is obtained and properly documented.
• Coordinates study visits and ensures all protocol required procedures are completed.

Research Data Coordination- 30%

• Maintains, updates, and monitors participant records and study databases in accordance with sponsor specifications.
• Performs data entry, quality checks, data cleaning, and query resolution.
• Prepares data summaries or exports to support ongoing study activities.
• May assist in the development or maintenance of study specific databases or participant tracking tools.

Documentation & Reporting -10%

• Collects, documents, monitors, and reports adverse events per sponsor, regulatory, and institutional requirements.
• Communicates with clinical teams to ensure timely reporting and follow up.

Regulatory Support & Monitoring Visit Coordination - 20%

• Assists in preparing IRB submissions, amendments, renewals, and other regulatory documentation.
• Maintains regulatory binders and study essential documents.
• Prepares for sponsor/CRO monitoring visits and supports resolution of findings.

Training, Compliance & Team Support - 10%

• Completes all required research compliance training, including Responsible Conduct of Research and CITI modules.
• Provides guidance or task based assistance to junior staff as needed.
• Ensures research operations adhere to institutional policies and good clinical practice (GCP).

Minimum Qualifications

• Bachelor's degree.
• Four years of relevant experience.

Preferred Qualifications

• Master’s degree in a related field preferred.
• Experience with multi-site study coordination and extensive research coordination.
• Highly organized, self‑motivated, collaborative, able to multitask, and perform well under pressure.
• Experience recruiting, screening, consenting, and scheduling research participants.
• Strong data management skills: database updates, data entry, quality checks, and query resolution.
• Ability to document and report adverse events per regulatory and sponsor requirements.
• Familiarity with IRB submissions, regulatory binders, and supporting monitoring visits.
• Knowledge of GCP standards, required research compliance training (CITI/RCR), and ability to support junior staff as needed.