Administrative - Clinical Research Associate

They work with pharmaceutical companies, medical device companies, clinical research organizations (CROs), and external vendors to negotiate study specific budgets, contract payment terms, master agreements, master fee schedules, and vendor service agreements. Duties: Coordinate study agreements to completion, including study contracts, Study Start-Up Agreements, Accelerated Start-Up, Service Agreements, Physician Agreements, Master Contracts, and Master Fee Schedules.

Ideal candidate will have over 4 years of experience working with patient facing Clinical Trials, and 3 years of experience working with contracts and budgeting. **Only accepting candidates local to Orange County at this time** Hybrid Schedule - 1-2 days per week will be spent in office. The first two weeks may be fully in office as well for training. Education: Bachelors Degree Required This role resides within the Finance department of Providence Medical Foundation s Research Shared Services (RSS) team. The Grants and Contracts Administrator analyzes essential trials documents and collaborates with clinical teams to develop and negotiate comprehensive budgets that cover institutional research costs. They work with pharmaceutical companies, medical device companies, clinical research organizations (CROs), and external vendors to negotiate study specific budgets, contract payment terms, master agreements, master fee schedules, and vendor service agreements. Aids in the training and development of lower level Grants and Contracts Administrators. Duties: Coordinate study agreements to completion, including study contracts, Study Start-Up Agreements, Accelerated Start-Up, Service Agreements, Physician Agreements, Master Contracts, and Master Fee Schedules. Prepare and provide tracked changes to contracts that require legal review for submission, monitor progress, provide feedback on institutional practices as applicable and prepare for execution in partnership with legal. Capable of reviewing protocols and completing the internal Qualifying Clinical Trial (QCT) checklist and determine the appropriateness of a Coverage Analysis (CA) on a study-by-study basis. Collect Principal Investigator signatures as applicable on the QCT checklist. In adherence to strict project timelines, develop and negotiate financially feasible budgets that ensure cost coverage of internal expenses. Collaborate with Site Teams to confirm resource and expense allocations on budgets while facilitating vendor costs as needed. Clearly document resource/payees for CTMS development. Displays understanding of billing compliance, fair market value, coverage analysis, study essential documents, policies and procedures, and internal quality controls. Displays understanding of budget and CA practices to review protocol amendment documents, protocol letters, and communications. Capable of determining impacts to coverage analysis, contract, and/or budget and the changes necessary as a result of amendment documents. Skilled in using Microsoft Office applications, primarily Excel, and capable of supporting enhancements to templates and tools for improved efficiency and ease. Displays understanding of the downstream effects from final work products by effectively collaborating with post-award teams for issue resolution and process improvement. Supports implementation of improvements to ease post-award workflows. Capable of adapting to changes, supports the implementation of new standards, and provides insightful ideas and feedback for necessary changes or improvements. Capable of supporting special projects requiring data analysis and data mining. Maintains complete and organized files of all project documents and documentation to Providence internal platforms. Cultivate and maintain positive working relationships with internal stakeholders as well as external sponsoring agencies. Capable of tracking clear metrics and maintaining or enhancing metric dashboards for KPI reporting and leadership review. Capable of providing feedback on questions and queries in adherence to expected timelines or provide updates when necessary.