Clinical Research Coordinator

About the role

The Clinical Research Coordinator (CRC) at Alcanza Clinical Research works to ensure the execution of assigned studies in compliance with GCP, ICH, HIPAA, FDA Regulations and SOPs. Responsibilities include screening patients for study enrollment, obtaining patient consents, conducting follow-up visits, documenting in source clinic charts, entering data in EDC systems, and resolving queries. Other duties may involve obtaining vital signs and ECGs, performing basic lab procedures, requesting and tracking medical record requests, updating logs, scheduling appointments, filing Serious Adverse Event (SAE)/Deviation reports, documenting adverse events, and maintaining confidentiality.

Responsibilities

• Screens patients for study enrollment
• Obtains patient consents
• Conducts patient follow-up visits
• Documents in source clinic charts
• Enters data in EDC systems and answers queries
• Obtains vital signs and ECGs
• Performs basic lab procedures (blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens, notification of courier for specimen pick-up)
• 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 files as needed
• Conducts monitoring visits and resolves issues as needed
• Ensures study-related reports and patient results are reviewed by the investigator in a timely manner
• Fills out SAE/Deviation reports to the Sponsor and IRB as needed
• 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
• Always 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 completing 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

Requirements

• 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, is required.
• Proficiency with performing basic clinical procedures such as (blood pressure, vitals, EKGs, phlebotomy, etc.) is highly preferred.
• Bi-lingual (English / Spanish) proficiency is a plus.

Qualifications

• 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, is required.
• Proficiency with performing basic clinical procedures such as (blood pressure, vitals, EKGs, phlebotomy, etc.) is highly preferred.
• Bi-lingual (English / Spanish) proficiency is a plus.

Skills

• 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 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.