Clinical Affairs Contracts Administrator (97519)
Minimum requirements:
5 years of experience managing contracts, budgets, compliance and financial reporting.
Experience working in clinical affairs and/or with clinical trials highly preferred.
Significant experience with SAP, Peachtree/Sage 50, or other financial accounting software.
Job Description:
Supports confidential disclosure agreements, contracts, service agreements, consulting agreements, payments and heath care provider reporting for Clinical Affairs (e.g., Sunshine Act, Massachusetts (MA) and Vermont (VT) reporting requirements). Facilitates clinical trial set up and execution. Coordinates supply ordering and budget formulation and tracking across clinical affairs projects in Tucson and Mountain View. Provides logistics support for project teams working on US and international clinical studies. Supports all aspects of contracts administration for design validation studies conducted by Clinical Affairs involving instruments, software and reagents for tissue-based in vitro diagnostic tests.
Essential Functions:
Develops, implements and maintains process for conducting fair market value assessments for contracted services and ensures consistent utilization. Analyzes benchmark data and recommends clinical study budgets based on fair market value determination.
Facilitates vendor selection, set up and contracting; coordinates ongoing maintenance of study contracts, budgets and financial reporting. Serves as Clinical Affairs liaison to Finance, Purchasing, Quality and Legal.
Coordinates all purchase requests for study teams. Enters purchase requests in SAP or current COMPANY approved software and obtains Purchase Order (PO) approvals. Provides status reports to clinical study teams and management as needed.
Approves invoices and tracks payments against purchase orders for study budgets and coordinates with vendors to facilitate payment requests being submitted within the PO window.
Generates reports from SAP to inform study teams and management of payment status compared to budget. Tracks and reports on various non-financial study metrics.
Serves as Subject Matter Expert (SME) for Sunshine Act, MA and VT reporting compliance; tracks and records Clinical Affairs payments for Sunshine Act compliance. Ensures appropriate documentation is maintained.
Coordinates purchase and shipping of clinical supplies to research/study sites.
Develops materials and trains clinical study teams on the Vendor Payment process. Adapts materials and training to reflect changes to procedures and/or policy and re-trains as needed.
Miscellaneous duties and special projects as assigned.
Knowledge, Skills, and Abilities:
Knowledge of accounting and budgeting principles.
General knowledge of clinical affairs reporting requirements, and ability to research and stay informed of clinical affairs compliance requirements.
Ability to work with relevant computer software packages, including spreadsheets and word-processing packages (e.g., Microsoft Excel, Microsoft Word).
Excellent communication and interpersonal skills.
Skill in managing and tracking details.
Ability to work under time pressure while maintaining high standards of precision and data quality.
Formal Training/Education:
Bachelor degree in finance, business or a related field. Equivalent combination of education and experience will be considered.
Estimated Salary: $20 to $28 per hour based on qualifications.
5 years of experience managing contracts, budgets, compliance and financial reporting.
Experience working in clinical affairs and/or with clinical trials highly preferred.
Significant experience with SAP, Peachtree/Sage 50, or other financial accounting software.
Job Description:
Supports confidential disclosure agreements, contracts, service agreements, consulting agreements, payments and heath care provider reporting for Clinical Affairs (e.g., Sunshine Act, Massachusetts (MA) and Vermont (VT) reporting requirements). Facilitates clinical trial set up and execution. Coordinates supply ordering and budget formulation and tracking across clinical affairs projects in Tucson and Mountain View. Provides logistics support for project teams working on US and international clinical studies. Supports all aspects of contracts administration for design validation studies conducted by Clinical Affairs involving instruments, software and reagents for tissue-based in vitro diagnostic tests.
Essential Functions:
Develops, implements and maintains process for conducting fair market value assessments for contracted services and ensures consistent utilization. Analyzes benchmark data and recommends clinical study budgets based on fair market value determination.
Facilitates vendor selection, set up and contracting; coordinates ongoing maintenance of study contracts, budgets and financial reporting. Serves as Clinical Affairs liaison to Finance, Purchasing, Quality and Legal.
Coordinates all purchase requests for study teams. Enters purchase requests in SAP or current COMPANY approved software and obtains Purchase Order (PO) approvals. Provides status reports to clinical study teams and management as needed.
Approves invoices and tracks payments against purchase orders for study budgets and coordinates with vendors to facilitate payment requests being submitted within the PO window.
Generates reports from SAP to inform study teams and management of payment status compared to budget. Tracks and reports on various non-financial study metrics.
Serves as Subject Matter Expert (SME) for Sunshine Act, MA and VT reporting compliance; tracks and records Clinical Affairs payments for Sunshine Act compliance. Ensures appropriate documentation is maintained.
Coordinates purchase and shipping of clinical supplies to research/study sites.
Develops materials and trains clinical study teams on the Vendor Payment process. Adapts materials and training to reflect changes to procedures and/or policy and re-trains as needed.
Miscellaneous duties and special projects as assigned.
Knowledge, Skills, and Abilities:
Knowledge of accounting and budgeting principles.
General knowledge of clinical affairs reporting requirements, and ability to research and stay informed of clinical affairs compliance requirements.
Ability to work with relevant computer software packages, including spreadsheets and word-processing packages (e.g., Microsoft Excel, Microsoft Word).
Excellent communication and interpersonal skills.
Skill in managing and tracking details.
Ability to work under time pressure while maintaining high standards of precision and data quality.
Formal Training/Education:
Bachelor degree in finance, business or a related field. Equivalent combination of education and experience will be considered.
Estimated Salary: $20 to $28 per hour based on qualifications.
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