Lauren Nevins Email & Phone Number

• Oversees operational activities and execution of 2 Cervical Disc IDE studies
• Provides site support and management of 30 study sites
• Manages and directs team of contract monitors
• Manages and directs internal Clinical Trial support staff
• Ensures study is in compliance with the protocol, informed consent obligations, recognized Good Clinical Practices, FDA’s IDE guidance documents, and federal regulations outlined in 21 CFR Part 812
• Conducts review and oversight of study safety- AEs, SAEs, Protocol deviations, and surgical interventions

• Oversees clinical projects within the functional areas of medical device, Pharma, IVD, and biologics
• Creates bids in response to requests for proposal
• Leads bid defense presentations
• Leads and manage the core cross functional study team as single point of accountability for operational delivery
• Committed to the management of study objectives, timelines, and budget goals
• Directs CRAs to ensure successful program execution

• Oversees the execution of start-up activities including pre-award and bid defense
• Develops regulatory start up plans according to the scope of work and project plans
• Lead a team of regulatory specialist and contract negotiators to execute start-up activities
• Deliver presentations to clients, colleagues and other professional team members as required
• Determine regulatory strategy and parameters for submissions and all necessary authorizations
• Ensure overall project efficiency and adherence to project timelines and financial goals are met.

Springfield, Illinois Metropolitan Area

Home-Based

-Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.-Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.-Administer protocol and related study training to assigned sites and establish regular lines of communication with.

• Conduct/Implement regularly scheduled CEC conference calls/face to face meetings as per trial needs.
• Maintains all CEC materials, including agenda, minutes, and CEC manual.
• Responsible for the review of medical records and adverse event narrative composition for medical device trials, specifically peripheral vascular studies.
• Provides all event adjudications and raw data sets to sponsor.
• Assist research site with IRB/regulatory submissions and ensure collection of essential documents for study start-up and throughout conduct of the study. Assure that all applicable regulatory requirements are being met.
• Conduct monitoring visits to assure the integrity of clinical data with respect to accuracy, accountability, documentation, and methods or procedures through review of CRFs, source documents, medical records, and.

• SynvaCor Analysis experience includes peripheral interventional vascular devices involving the coronary, superficial femoral, popliteal, infrapopliteal, renal and pelvic arteries.
• Organize study project plans to assist in efficient implementation, perform literature searches; compiles and organizes current publications, assists in investigative site education regarding the acquisition of.
• Clinical Cardiac and Angiographic Catherization lab experience to include: Cardiac and peripheral procedures, familiar with multiple devices and equipment, angiography and direct communication with doctors and staff.
• Experienced in the development of angiographic and wound acquisition protocols as well as CRF development, trial worksheets and study specific training materials.

• Preformed data organization and entry.
• Completed animal handling training and safety training.
• Skillfully utilized acoustic isolation chambers and small animal operant conditioning.
• Performed ABR instrumentation.
• Operated stereotaxic surgical instrumentation.
• Mastered in-depth research of tinnitus.

Bachelor'S Degree, Biology, General

Education record