- Flexible Approved Time Off. verification source document review, review for compliance with required reporting tracking of adverse events and protocol deviations, investigator site file review, laboratory tour and specimen storage assessment, pharmacy Investigational Product IP Investigational Device ID storage location tour and Storage condition assessment, IP ID accountability, facilities tours, and other activities per the site monitoring plan under minimal direction from the project CRA staff oversight lead.
table style="margin:0px;padding:0px;border-collapse:collapse;width:auto;color:#000000;font-family:'roboto' , 'helvetica neue' , 'helvetica' , 'arial' , sans-serif;font-size:12px;font-weight:400;border:none">- Flexible Approved Time Off.
- As part of the site visits, independently conducts Informed Consent (ICF) review, source data verification/source document review, review for compliance with required reporting/tracking of adverse events and protocol deviations, investigator site file review, laboratory tour and specimen storage assessment, pharmacy/Investigational Product (IP)/Investigational Device (ID) storage location tour and storage condition assessment, IP/ID accountability, facilities tours, and other activities per the site monitoring plan under minimal direction from the project CRA staff oversight lead.
table style="margin:0px;padding:0px;border-collapse:collapse;width:auto;color:#000000;font-family:'roboto' , 'helvetica neue' , 'helvetica' , 'arial' , sans-serif;font-size:12px;font-weight:400;border:none">- Flexible Approved Time Off.
Ensures study timelines and deliverables are met by CRA staff, including, but not limited to, development of the clinical monitoring plan per the Statement of Work (SOW), evaluation of the risk-based monitoring strategy, monitoring visit frequency, monitoring visit report submission/approval timelines, study data collection timelines, and the annotated reports per the project SOW and/or Emmes SOPs. table style="margin:0px;padding:0px;border-collapse:collapse;width:auto;color:#000000;font-family:'roboto' , 'helvetica neue' , 'helvetica' , 'arial' , sans-serif;font-size:12px;font-weight:400;border:none">- Flexible Approved Time Off. Responsibilities:
- Accountable for day-to-day execution of government research projects through collaboration with assigned projects' Emmes' project PI/Coordinating Center leader(s) and staff from other departments, including but not limited to Clinical Operations, Biostatistics, Clinical Data Management, Clinical Data Systems, Program Management, IT, Web Development, Finance, Contracts, Regulatory and Pharmacovigilance.
table style="margin:0px;padding:0px;border-collapse:collapse;width:auto;color:#000000;font-family:'roboto' , 'helvetica neue' , 'helvetica' , 'arial' , sans-serif;font-size:12px;font-weight:400;border:none">- Flexible Approved Time Off. Responsibilities:
- Accountable for technical, scientific, and fiscal execution of government research projects through collaboration with staff from multiple departments, including Clinical Operations, Biostatistics, Clinical Data Management, Clinical Data Systems, Program Management, IT, Web Development, Finance, Contracts, Regulatory, and Pharmacovigilance.
table style="margin:0px;padding:0px;border-collapse:collapse;width:auto;color:#000000;font-family:'roboto' , 'helvetica neue' , 'helvetica' , 'arial' , sans-serif;font-size:12px;font-weight:400;border:none">- Flexible Approved Time Off.
| - Work From Home Anywhere in the US.
table style="margin:0px;padding:0px;border-collapse:collapse;width:auto;color:#000000;font-family:'roboto' , 'helvetica neue' , 'helvetica' , 'arial' , sans-serif;font-size:12px;font-weight:400;border:none">- Flexible Approved Time Off.
Leads collaborations with clinical investigators to determine study design, contributes to protocol development, authors statistical analysis plans, performs statistical analysis, makes statistical inference and writes and presents reports summarizing findings including publications in peer reviewed journals. table style="margin:0px;padding:0px;border-collapse:collapse;width:auto;color:#000000;font-family:'roboto' , 'helvetica neue' , 'helvetica' , 'arial' , sans-serif;font-size:12px;font-weight:400;border:none">- Flexible Approved Time Off.
| - Work From Home Anywhere in the US.
table style="margin:0px;padding:0px;border-collapse:collapse;width:auto;color:#000000;font-family:'roboto' , 'helvetica neue' , 'helvetica' , 'arial' , sans-serif;font-size:12px;font-weight:400;border:none">- Flexible Approved Time Off.
| - Work From Home Anywhere in the US.
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