Clinical Research Coordinator

About the role

Department: Operations. Location: Innovation - Palmetto Bay, FL.

Alcanza is a growing multi-site, multi-phase clinical research company with a network of locations in AL, AZ, FL, GA, IL, MA, MI, MO, NV, VA, SC, TN, TX and Puerto Rico. The company has established a strong presence across Phase I–IV studies and several therapeutic areas including vaccine, neurology, dermatology, psychiatry, and general medicine. The Clinical Research Coordinator works to ensure the execution of assigned studies in compliance with GCP, ICH, HIPAA, FDA Regulations and SOPs.

Responsibilities

• Screen patients for study enrollment
• Obtain patient consents
• Conduct patient follow-up visits
• Document in source clinic charts
• Enter data in EDC and answer queries
• Obtain vital signs and ECGs
• Perform basic lab procedures per protocol: blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens, and notification of courier for specimen pick-up
• Request and track medical record requests
• 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 documentation 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
• Report non-compliance to appropriate staff in a timely manner
• Maintain positive and effective communication with clients and team members
• Practice ALCOAC principles with all documentation
• Assist with study recruitment, patient enrollment, and tracking as needed
• Maintain confidentiality of patients, customers, and company information
• Complete all activities for study start-up, including required training and uploading/printing certificates for the 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

Qualifications

• Medical Assistant diploma, LPN/LVN, EMT credential, or Associate's degree
• Minimum of 1 year of clinical research or clinical experience (or equivalent combination of education and experience)
• Proficiency with basic clinical procedures (blood pressure, vitals, EKGs, phlebotomy, etc.) highly preferred
• Bilingual English/Spanish proficiency a plus

Skills

• Proficiency with computer applications: Microsoft applications, email, electronic health records, web applications, and typing at 40+ wpm
• Performing basic clinical procedures: blood pressure, vitals, EKGs, phlebotomy, etc.
• Strong organizational skills and attention to detail
• Well-developed written and verbal communication skills
• Well-developed interpersonal and listening skills; ability to work independently and collaboratively with co-workers, subjects, managers, and external customers
• Ability to effectively handle multiple tasks and adapt to changes in workloads and priorities
• Professional, respectful, self-motivated, with a 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 professionally, 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, and vision insurance
• Life insurance
• Short- and long-term disability insurance
• Health savings accounts
• Supplemental insurances
• 401(k) plan with a safe harbor match