Senior Research Associate, Clinical (Temporary) Novato United States,
- Timeline: Establishes and manages timelines for assigned study while considering strategic objectives and corporate priorities.
- Study Documents: Leads the preparation and finalization of clinical study documents including, but not limited to: protocols, Informed Consent Document templates, eCRF Completion Guideline, Monitoring Plans, etc. Set-up and management of sponsored study documentation in official repositories (e.g., electronic systems).
- Participates in or leads the planning and execution study meetings (i.e., study team meetings, advisory boards, investigator meetings, etc.).
- Participate with Study Lead on study feasibility assessments activities.
- Periodically reviews adverse events and data listings, works with Pharmacovigiliance, Medical Monitor and colleagues on reconciliation Oversees required communication to site staff or designee regarding issues identified during reconciliation.
- Manages data discrepancies for the entire study and coordinates the clinical monitoring activities to ensure that these discrepancies are resolved in the established timeframe for resolution.
- Manages laboratory specimen collection process where applicable including interfacing with BioMarin laboratory and vendors. Ensures supplies for specimen collection are adequate at the site and site staff is trained on collection and shipment process.
- Vendor Management: Participates in the selection and management (i.e., contracts, budgets, tracking of planned vs actual spend) of study vendors as applicable.
- Facilitation/Planning: Facilitate short and long term planning for assigned studies. Works with Directors or designee on budget planning process for assigned study. Develop and implement contingency planning with Directors or designee support.
- Creates clinical study metrics and other management reporting tools.
- Identifies problems/issues and reports findings to Directors or designee.
- Generates investigator/site payment requests or appropriately delegates to support staff.
- Project specific budget development and management (i.e., accruals, reforecasting and long range planning).
- At least five years experience as a Clinical Research Associate. Experience in the management of multiple sites as a Clinical Research Associate is preferred.
- Extensive experience with study design, planning and implementation.
- Study documents writing experience (i.e., protocol, ICD templates, eCRF Completion Guidelines, Monitoring Plans, etc.).
- Experience with PleaseReview preferred.
- Advanced verbal and written communication skills, in addition to excellent organizational skills and management of cross-functional teams.
Bachelor s degree, preferably in a scientific field
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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