Sonya Ridner Email & Phone Number

United States

Regional

Cincinnati

• Bathing• Feeding• Personal Care• Companionship• Assist with daily activities

Remote

Performs assigned activities within the country that lead to start-up of investigative sites in all phases of clinical trials. Responsible for providing delivery and expertise in one or more of the following functional areas: investigator site contracts, ethics and regulatory submissions, and review and finalization of essential documents required for site initiation. Ensures local activities are undertaken in accordance with agreed timelines, allocated budgets, and required quality standards. Ensures an efficient start-up process on assigned studies. At a project and local level, may act as Site Start-up Lead (SSUL). Act as main contact with Regulatory Authorities (RA) and Central/Regional Ethics Committees (ECs). Under the direction of the Project Manager (PM) or SSUL as appropriate , may directly interact with Customers when receive requirements from RA or other local regulatory party . Accountable to the PM/SSUL at the project level and line manager for deliverables . At a project level , may act as SSUL for local studies. May act as the Country Start-Up Advisor (CSA).

Cincinnati, Ohio

Provides customer-focused leadership in the execution of the start up of sites in one or multiple Phase II through Phase IV clinical trials across all functional Site Start-Up (SSU) areas. Accountable for the delivery of activation ready study sites on time, on budget, and in compliance with all applicable regulations. Responsible for managing all site start-up activities from site selection/recommendation thru site-activation ready, developing integrated site start-up timelines, and reporting weekly progress to the project team Project Manager (PM) including plans to address potential risks/gaps. Serves as a regional SSU liaison for the project team. May contribute to the business development process by reviewing proposals, attending and presenting at client meetings. Performs the role for maintenance studies and assists more senior SSU PMs with complex global studies and programs in ensuring efficient production of all SSU deliverables across multiple functions

Processes essential documents for inclusion in the Trial Master File (TMF), and manages study trialdocumentation from the completion of the regulatory start-up packet to study closure. Commonlyperforms a QC of post start-up documentation to ensure documentation is compliant with ICH/GCP,regulatory, and sponsor requirements. Collaborates with the project team to maintain an up-to-date and complete TMF through-out the life of the clinical trial. Participates as a quality review team member responsible for conducting a review of the study specific TMF. Participates in the training/mentoring of Regulatory Records Specialists, and assists in developing training plans, conducting training sessions, and executing training activities.

Cincinnati

Processes essential documents for inclusion in the Trial Master File (TMF)Manages study trial documentation from the completion of the regulatory start-up packet to study closure QC of post start-up documentation to ensure documentation is compliant with ICH/GCP, regulatory, and sponsor requirements. Collaborates with the project team to maintain an up-to-date and complete TMF through-out the life of the clinical trial.

Cincinnati Ohio

• Oversee daily functions in all areas of the store and all personnel • Detail to Customer Service• Scheduling• Ordering• Cash control• Inventory Control• Budgeting sales and hours

Regulations Of Clinical Trials

Diploma, Business