Perform basic lab procedures per protocol: blood specimen collection, centrifuge operation, storing and shipping specimens, specimen accountability, and courier coordination.
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.
Conduct monitoring visits and resolve issues in a timely manner; ensure study reports and patient results are reviewed by investigator.
File SAE/Deviation reports to Sponsor and IRB as needed; document and report adverse events; report non-compliance to appropriate staff.
Maintain positive and effective communication with clients and team members; maintain confidentiality of patients, customers and company information.
Complete study start-up activities including required training, uploading/printing certificates to ISF; prepare and attend site initiation visits (SIVs) and Investigator Meetings (IMs).
May assist with study recruitment, enrollment, tracking, and set up/train/maintain study technology.
Perform all other duties as requested or assigned.
Requirements
A Medical Assistant diploma, LPN/LVN, EMT credential OR Associate’s degree AND a minimum of 1 year of clinical research or clinical experience, OR an equivalent combination of education and experience.
Vaccine trial experience required.
Proficiency with performing basic clinical procedures such as blood pressure, vitals, EKGs, phlebotomy (preferred).
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; ability to work independently and 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, 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 in a confidential and professional manner, in compliance with HIPAA guidelines.