Clinical Research Coordinator

Clinical Research Coordinator

Job Summary

The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the Research Director and clinical Principal Investigator (Pl). While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC supports, facilitates, and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. By performing these duties, the CRC works with the PI, department, sponsor, and institution to support and provide guidance on the administration of the compliance, and other aspects of the clinical study.

Essential Responsibilities:

• Responsible for ensuring all FDA and GCP guidelines are strictly adhered to and follow all Standard Operating Procedures for ACCR
• Plan and coordinate the initiation of research study protocol
• Plan, implement, and maintain data collection and analysis systems in support of research protocol
• Recruit, instruct, and coordinate research subjects, as appropriate to specific study objectives and work scope. Must be able to screen patient charts, and have the critical thinking skills necessary to make independent decisions based on outlined screening qualifications each study presents. The expectation is minimum of one patient screened in clinic per study for average job performance.
• Responsible for all recruitment and retention for assigned protocol. Communicate enrollment barriers immediately to Director. Create and maintain weekly screening log for all assigned studies.
• Answer phones and direct calls to the appropriate individual
• Responsible for hands on patient care, including rooming subjects, vital signs, EKG's, lab draws, processing specimens, and other clinical tests as needed. Maintain lab supply for all visits required by protocol.
• Create source documents as needed for individual studies
• Data entry of completed source docs within a maximum of 5 days unless otherwise dictated by sponsor/CRO. Query resolution within 3 days for all assigned studies.
• Attend Investigator, site initiation and other training meetings as necessary
• Organizing regulatory files and filing all documents in study files 48 hours prior to any sponsor/CRA visit
• Obtain all required signatures within 5 business days
• Conduct weekly check ins with clinic staff about current studies
• Obtain thorough medical histories for all possible subjects

Qualifications

Education: High School Diploma required; Bachelor’s/Master’s preferred

Clinical Research Experience: Preferred, but not required

Knowledge of medical terminology: Required

• Ability to read, write, and understand medical terminology
• Ability to effectively organize files, meet deadlines, write routine documents, speak clearly, and solve practical problems
• Ability to complete tasks autonomously and take initiative to complete their work
• Ability to work with others in a wide variety of circumstances
• Ability to work with diverse groups of people

Language Skills

Must have the ability to read, analyze, and interpret complex documents, respond effectively to sensitive inquiries or complaints.

Clearances

Criminal Background Check

TB Clearance

Hep B Clearance

Testing

Pre-employment drug testing

Physical Demands

While performing the duties for this job, the employee is occasionally required to stand, walk, and sit for long periods of time. The employee must occasionally lift up to 25lbs.

Salary

Commensurate with experience