Travel Clinical Research Coordinator Alcanza Clinical ResearchTravel Clinical Research CoordinatorLake Mary, FloridaRemoteResponsibilities may include but are not limited to: Under the direction of the Site Manager/Director and the Principal/Sub Investigators, conducts the following according to study protocol, company processes & procedures, and in compliance with FDA, GCP, ICH regulations and guidelines: Screening of patients for study enrollment; Patient consents; Patient follow-up visits; Documenting in source clinic charts; Entering data in EDC and answers 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; o Filing SAE/Deviation reports to Sponsor and IRB as needed; o Documenting and reporting adverse events; o Reporting non-compliance to appropriate staff in timely manner; o Maintaining positive and effective communication with clients and team. Prepare and attend site initiation visits (SIV’s) and Investigator Meetings (IMs), as needed; Handles all IRB functions for assigned studies independently, and/or with assigned regulatory team member, as needed; Assist with training of new research assistants and coordinators; Assist with scheduling and planning for visit capacity for assigned studies; May set up, train and maintain all technology needed for studies; May assist with study recruitment, patient enrollment, and tracking as needed; May handle more complex study assignments and volumes; May participate in community outreach / education events; Maintaining confidentiality of patients, customers and company information, and; Performing all other duties as requested or assigned.
NewClinical Trial Manager - East Coast HeartFlowClinical Trial Manager - East CoastOrlando, FLRemote$95,000–$125,000 / yearHeartflow is the first AI-driven non-invasive integrated heart care solution across the CCTA pathway that helps clinicians identify stenoses in the coronary arteries (RoadMapAnalysis), assess coronary blood flow (FFRCT Analysis), and characterize and quantify coronary atherosclerosis (Plaque Analysis). The flagship product-an AI-driven, non-invasive cardiac test supported by the ACC/AHA Chest Pain Guidelines called the Heartflow FFRCT Analysis-provides a color-coded, 3D model of a patient's coronary arteries indicating the impact blockages have on blood flow to the heart.