Clinical Research Coordinator

Key Responsibilities

• Screens patients for study enrollment
• Obtains patient consents
• Follows up with patients for study visits
• Documents in source clinic charts
• Enters data in Electronic Data Capture (EDC) system and answers queries
• Performs basic lab procedures as per protocol
• Requests and tracks medical record requests
• Updates and maintains logs, chart filings
• Maintains and orders study-specific supplies
• Schedules subjects for study visits and conducts appointment reminders
• Builds and updates source documents as needed
• Conducts monitoring visits and resolves issues as needed
• Reviews study-related reports and patient results with the investigator
• Fills out Serious Adverse Event (SAE)/Non-Conformance (Deviation) reports to Sponsor and Institutional Review Board (IRB)
• Documents and reports adverse events
• Reports non-compliance to appropriate staff in a timely manner
• Maintains positive and effective communication with clients and team members
• Practices ALCOAC principles with all documentation
• May assist with study recruitment, patient enrollment, and tracking as needed
• Maintains confidentiality of patients, customers, and company information
• Completes all necessary activities for study start-up, including required training, uploading/printing certificates to file in ISF, etc.
• Prepares and attends site initiation visits (SIV’s) and Investigator Meetings (IMs), as needed
• May set up, train, and maintain all technology needed for studies

Skills, Knowledge And Expertise

• A Medical Assistant diploma, LPN/LVN, EMT credential OR an Associate’s degree AND a minimum of 1 year of clinical research or clinical experience, OR an equivalent combination of education and experience
• Proficiency with performing basic clinical procedures such as blood pressure, vitals, EKGs, phlebotomy, etc
• Bi-lingual (English / Spanish) proficiency is a plus
• Proficiency with computer applications such as Microsoft applications, email, electronic health records, web applications, and the ability to type proficiently (40+ wpm)
• Strong organizational skills and attention to detail
• Well-developed written and verbal communication skills
• Well-developed interpersonal and listening skills and the ability to work well independently as well as with co-workers, subjects, managers and external customers
• Ability to effectively handle multiple tasks, and adapt to changes in workloads and priorities
• Ability to work under minimal supervision, identify problems and implement solutions
• Ability to handle highly sensitive information in a confidential and professional manner, and in compliance with HIPAA guidelines

Benefits

• Full-time employees regularly scheduled to work at least 30 hours per week are benefits-eligible, with coverage starting on the first day of the month following date of hire
• Medical, dental, vision, life insurance, short and long-term disability insurance, health savings accounts, supplemental insurances, and a 401k plan with a safe harbor match are offered