Responsibilities may include but are not limited to: • Screening of patients for study enrollment • Patient consents • Patient follow-up visits • Documenting in source clinic charts • Entering data in EDC and answering queries • Obtaining vital signs and ECGs • May perform basic lab procedures per protocol such as blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens, and notification of courier for specimen pick-up • Requesting and tracking medical record requests • Updating and maintaining logs, chart filings • Maintaining & ordering study specific supplies • Scheduling subjects for study visits and conducts appointment reminders • Building, updating source as needed • Conducting monitoring visits and resolves issues as needed in a timely manner • Ensuring study related reports and patient results are reviewed by investigator in a timely manner • Filing SAE • Deviation reports to Sponsor and IRB as needed • Documenting and reporting adverse events • Reporting non-compliance to appropriate staff in timely manner • Maintaining positive and effective communication with clients and team members • Always practicing ALCOA principles with all documentation • May assist with study recruitment, patient enrollment, and tracking as needed • Maintaining confidentiality of patients, customers, and company information • Performing all other duties as requested or assigned • Complete all needed activities for study start-up including completing required training, uploading printing certificates to file in ISF, etc. • Proficiency with computer applications such as Microsoft applications, email, electronic health records, web applications, and the ability to type proficiently 40 wpm • Performing basic clinical procedures such as blood pressure, vitals, EKGs, phlebotomy, etc.