Kristen Covington Email & Phone Number

Columbia, Sc, Us

United States

-Perform feasibility studies for potential sites as requested-Conduct pre-study, study initiation and interim monitoring visits in adherence to the protocol requirements-Compile and ensure completeness of regulatory documents and ethical submission documentation as appropriate and required (e.g. IRB / IEC study approval, informed consent, etc.)-Coordinate study material (e.g. CRFs, manuals) shipment and receipt by study site-Document site visit findings via written reports-Assess, monitor, and train study site staff on protocol adherence as required-Review study subject safety information and informed consent-Conduct source document verification for compliance, patient safety, and veracity of data-Review CRFs using paper or electronic data capture systems-Assist the site in maintenance of the Investigator Site File-Maintain regular communication with sites-Provide applicable updates for site related documentation for filing in the Trial Master File (TMF)-Assist sites in data query resolution-Ensure site compliance with IP receipt, accountability and return or destruction-Complete final site close out visit and report

-Perform feasibility studies for potential sites as requested-Conduct pre-study, study initiation and interim monitoring visits in adherence to the protocol requirements-Compile and ensure completeness of regulatory documents and ethical submission documentation as appropriate and required (e.g. IRB / IEC study approval, informed consent, etc.)-Coordinate study material (e.g. CRFs, manuals) shipment and receipt by study site-Document site visit findings via written reports-Assess, monitor, and train study site staff on protocol adherence as required-Review study subject safety information and informed consent-Conduct source document verification for compliance, patient safety, and veracity of data-Review CRFs using paper or electronic data capture systems-Assist the site in maintenance of the Investigator Site File-Maintain regular communication with sites-Provide applicable updates for site related documentation for filing in the Trial Master File (TMF)-Assist sites in data query resolution-Ensure site compliance with IP receipt, accountability and return or destruction-Complete final site close out visit and report

Raleigh, North Carolina, United States

-Conduct pre-study, study initiation and interim monitoring visits in adherence to the protocol requirements-Compile and ensure completeness of regulatory documents and ethical submission documentation as appropriate and required (e.g. IRB / IEC study approval, informed consent, etc.)-Coordinate study material (e.g. CRFs, manuals) shipment and receipt by study site-Document site visit findings via written reports-Assess, monitor, and train study site staff on protocol adherence as required-Review study subject safety information and informed consent-Conduct source documentation review and source data verification for compliance, patient safety, and veracity of data-Review CRFs using paper or electronic data capture systems-Assist the site in maintenance of the Investigator Site File-Maintain regular communication with sites-Provide applicable updates for site related documentation for filing in the Trial Master File (TMF)-Assist sites in data query resolution-Ensure site compliance with IP receipt, accountability and return or destruction-Complete final site close out visit and report-Actively participate in learning assignments, group discussions, root cause investigations, and group assignments throughout the CRA Academy training program

• Perform feasibility studies/site identification activities for potential sites, as requested• Coordinate study material (e.g. CRFs, manuals) shipment and receipt by study site• Ensure completeness and compile regulatory documents and ethical submission documentation as appropriate and required (e.g. IRB approval, informed consent, lab certification etc.)• Provide applicable updates for site related documentation for filing in the Trial Master File (TMF)• Assure maintenance of the Investigator Site File in the TMF• Conduct pre-study, study initiation and interim monitoring visits under the guidance of the local CRA or LCRA/PM, as applicable and appropriate• Document site visit findings at site visits via written reports, under the guidance of the local CRA or LCRA/PM, as applicable and appropriate• Maintain regular communication with sites• Complete remote CRF review, using electronic data capture systems• Assist sites in query resolution• Assist with ensuring site compliance with IP receipt, accountability and return or destruction, as applicable and appropriate • Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive

•Develop and maintain documents, tools, forms and related items in MS Word, Excel, Access and Publisher, including reformatting and troubleshooting issues with existing documents and macros•Assist Clinical Operations personnel with study initiations and special projects•Provide technical assistance to project team (Project Managers, Lead CRAs, CRAs, etc.) with forms, letters, reports, manuals and other documents•Manage document control functions, including maintaining Master List of paper and electronic documents and media generated and distributed•Audit and resolve issues of redundancy, currency and consistency of documents on shared drive and portals•Maintain and quality audit to assure most recent revisions of documents are on portals and server•Assist project team (CRAs, Lead CRAs and Project Managers, etc.) with collation of documentation required for submission to Regulatory Authorities and Ethics Committees administrative support to the preparation of contracts•Assist with maintenance of trial master file documents as appropriate and needed•In liaison with the CRAs, manage preparation of documents for grant payments•Regularly review the status of key documentation in the file for SOP compliance•Provide support to Clinical Operations Manager on an ad hoc basis.

International Studies, European Studies/Civilization

Spanish Language And Culture