Clinical Research Coordinator

About the role

Alcanza is a growing multi-site, multi-phase clinical research company with a network of locations across the United States and Puerto Rico. We specialize in Phase I-IV studies across several therapeutic areas, including vaccine, neurology, dermatology, psychiatry, and general medicine. The Clinical Research Coordinator (CRC) ensures the execution of assigned studies in compliance with GCP, ICH, HIPAA, FDA Regulations, and SOPs.

Responsibilities

• Screen patients for study enrollment and obtain patient consents.
• Conduct patient follow-up visits and document in source clinic charts.
• Enter data in EDC and respond to queries.
• Obtain vital signs and ECGs; perform basic lab procedures per protocol (e.g., blood specimen collection, centrifuge operation, storing and shipping lab specimens).
• Request and track medical records; update and maintain logs and chart filings.
• Maintain and order study-specific supplies.
• Schedule subjects for study visits and conduct appointment reminders.
• Build and update source documents as needed.
• Conduct monitoring visits and resolve issues in a timely manner.
• Ensure study-related reports and patient results are reviewed by the investigator promptly.
• File SAE/Deviation reports to Sponsor and IRB as needed.
• Document and report adverse events and non-compliance to appropriate staff.
• Maintain positive and effective communication with clients and team members.
• Adhere to ALCOAC principles in all documentation.
• Assist with study recruitment, patient enrollment, and tracking as needed.
• Maintain confidentiality of patients, customers, and company information.
• Complete study start-up activities, including required training and uploading/printing certificates to file in ISF.
• Prepare for and attend site initiation visits (SIVs) and Investigator Meetings (IMs) as needed.
• Set up, train, and maintain all technology needed for studies.
• Perform all other duties as requested or assigned.

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.
• Proficiency with basic clinical procedures (e.g., blood pressure, vitals, EKGs, phlebotomy) is highly preferred.
• Bilingual (English/Spanish) proficiency is a plus.

Skills

• Proficiency with computer applications (e.g., Microsoft Office, email, electronic health records, web applications) and typing (40+ WPM).
• Strong organizational skills and attention to detail.
• Well-developed written and verbal communication skills.
• Strong interpersonal and listening skills; ability to work independently and collaboratively with team members, subjects, managers, and external customers.
• Ability to handle multiple tasks, adapt to changing workloads, and prioritize effectively.
• Professional, respectful, self-motivated, and strong work ethic.
• High degree of integrity and dependability.
• Ability to work under minimal supervision, identify problems, and implement solutions.
• Ability to handle highly sensitive information confidentially 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 the date of hire.

• Medical, dental, and vision insurance.
• Life insurance and short/long-term disability insurance.
• Health savings accounts and supplemental insurances.
• 401k plan with a safe harbor match.