Mobile, Alabama, United States
-Review global data in a remote setting -Review clinical data; to include, patient profile review and data listings review (study data within a project database) -Evaluate clinical data previously queried to determine query resolution and data integrity -Utilize Excel spreadsheet technology; develop evaluable data derived from data listings; such as, ECG QTc data, dosing data -Assess data quality by performing targeted reviews defined by study teams and agreed upon by the DRT Lead -Maintain a cumulative repository of work product, both locally (personal computer) and on a shared DRT Sharepoint space -Effectively coordinate with other DRT members to create reports and summaries for reporting of work product -Based on review findings, provide input to DRT Lead and study teams in an effort to further improve study data -Be flexible and adapt quickly to changes in tasks and priorities -Successfully adopt the primary DRT goal of “help without hindering” - Always put quality of effort first -As needed, interact with CRAs in order to confirm outcomes of data-related questions -Manage resourcing of DRT members effectively with other DRT Leads and DRT manager -Attend clinical team meetings and provide updates on status of DRT reviews
-Provided oversight and coordination of site selection efforts for assigned therapeutic area(s) and protocols within territory (zone) in order to meet all site selection deliverables -Facilitated the development of strategies including planning, support, territory (zone) development, and delivery of key sites -Identified qualified investigators and developed high performing sites within assigned territory (zone) in each region -Coordinated Pre-trial assessments (PTA) and completion of visits/reports as needed
-Identified and selected Investigators for clinical trials, performed Site Selection, Site Initiation, Routine Monitoring and Site Closure visits -Managed assigned investigational study sites and perform on-site quality reviews of Case Report Form data -Ensured investigative sites were in compliance with protocol, FDA regulations and ICH/GCP guidelines and company standard operating procedures -Reviewed site study file notebook for completeness and up-to-date information including IRB-related documents -Reviewed Informed Consent forms for accuracy and regulatory compliance -Ensured proper administration of Informed Consent and advised site of any execution issues -Performed drug accountability and maintained adequate study supplies -Oversaw and evaluated subject enrollment
-Performed and coordinated all aspects of the clinical monitoring process in accordance with GCPs, ICH Guidelines, FDA Regulations, and global SOPs to assess the safety and efficacy of investigational products. -Assisted with site selection; conducted pre-study visits, initiation visits, interim monitoring visits, and close-out visits; attended Investigator or Study Coordinator meetings. -Conducted drug accountability and ensured proper handling/storage of investigational product; completed monitoring reports for all visits conducted. -Maintained responsibility for management of the clinical trial site and adherence to sponsor specific operating procedures and agreements; reviewed and ensured that all patient, site tracking records, and regulatory documents for assigned sites were current, complete and accurate. -Input tracking information into study management systems as required. -Represented the sponsor in the global medical research community and developed collaborative relationships with investigative sites and client company personnel.
-Performed and coordinated all aspects of the clinical monitoring process in accordance with GCPs, ICH Guidelines, FDA Regulations, and global SOPs to assess the safety and efficacy of investigational products. -Assisted with site selection; conducted pre-study visits, initiation visits, interim monitoring visits, and close-out visits; attended Investigator or Study Coordinator meetings. -Conducted drug accountability and ensured proper handling/storage of investigational product; completed monitoring reports for all visits conducted. -Maintained responsibility for management of the clinical trial site and adherence to sponsor specific operating procedures and agreements; reviewed and ensured that all patient, site tracking records, and regulatory documents for assigned sites were current, complete and accurate. -Input tracking information into study management systems as required. -Represented the sponsor in the global medical research community and developed collaborative relationships