Clinical Research Coordinator II Alcanza Clinical Research LLCClinical Research Coordinator IIFredericksburg, VAResponsibilities 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 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.
Clinical Research Coordinator II Alcanza Clinical ResearchClinical Research Coordinator IIFredericksburg, VAResponsibilities 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 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.