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• Creates and maintains study required E6 R2 GCP documentation and the Code of federal regulations Title 21 in electronic Trial Master File

• 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• Assists in the development and execution of site training, investigator meetings, and product training• Drives project execution through proactive tea management • Develops corrective and preventative action plans as needed• Assists with development of study materials including protocols, Informed Consent, and Study Plans

• 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.• Report and adhere to study specific performance metrics

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 sites to manage ongoing project expectations and issues.

• 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 by the site.• 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 regulatory documents.• Prepare monitor visit reports (e.g. site selection, site initiation, interim visit, and close-out visit) and pre/post site visit letters • Assist with the implementation of quality assurance to include regularly scheduled audits of research records for thoroughness, accuracy, and timely submission to sponsoring companies• Clinical Research experience includes First-in-man trials as well as phase I-IV cardiovascular and peripheral vascular device trials.

• 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 protocol specific implementation, maintains a log of all angiographic images received from outside institutions and provides image performance feedback/image quality issues to sponsor as needed; assists in data analysis after the execution of research protocols for both the angiographic and wound core laboratories; relays image analysis verification issues to SynvaCor Medical Director; perform a variety of duties involved in the organization, documentation and compilation of analysis data for sponsor and FDA.• 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.• Identified medication for treatment of tinnitus

Bachelor'S Degree, Biology, General

Education record