Clinical Research Assistant

Position Summary

Under direction, the Clinical Research Assistant assists in the administration, execution, and overall management of clinical research studies.

Responsibilities

• Coordinates clinical trials data management in compliance with federal regulations, GCP guidelines & internal policies. Ensures accurate & timely data compilation.
• Assists research team with facilitating enrollment, treatment & data collection of subjects.
• Generates study-specific tools to ensure protocol compliance.
• Assists in screening of potential subjects; registers eligible subjects with the sponsoring agency accordingly.
• Maintains complete research charts for assigned caseload of subjects.
• Completes all required case report forms and resolves all outstanding queries in timely manner.
• Preparing, coordinating, and processing research lab kits as required.
• Assists in coordinating protocol schedule of events.
• Reports all Adverse Events and Serious Adverse Events (SAEs) to Institutional Review Board and other agencies, as required.
• Functions as liaison with sponsoring agencies.
• Coordinates site visits and audits of clinical trials in conjunction with all pertinent staff, including: the monitor/auditor, the regulatory office, investigational pharmacy, and investigators.
• Maintains and disseminates accurate listing(s) of active and potential study subjects to participating investigators.
• Acts as a resource for detailed information on assigned protocols and other investigational research activities.
• Performs other job related duties as required.

Qualifications

• High School Diploma required.
• Bachelor's degree preferred.
• Previous related experience in a hospital, research, or university environment.

Skills

• Demonstrated ability to multi-task and prioritize in a fast-paced environment.
• Demonstrated strong communication and interpersonal skills; demonstrated ability to interact with multiple constituencies and exercise "people skills".
• Demonstrated organizational skills and ability to pay close attention to detail.
• Demonstrated proficiency with MS Office Suite and database applications.

Pay & Schedule

• Salary range: $24.29 - $27.09 per hour
• Weekly hours: 35.00
• Exemption status: Non-Exempt
• Location: Upper East Side

Travel may be required.