Professional Summary: * Certified clinical research professional with nearly 10 years of clinical research experience in the medical device industry. I have a wide range of knowledge with site and study management having worked as an In-house/Field CRA, Lead CRA and Clinical Trial Assistant. * Conducting: Qualification, Initiation and Close-Out monitoring visits for pre and post-market trials. * Start-up activities for both post-market and IDE trials (collection of regulatory study start-up documentation, budget/contract negotiations, preparing/assisting in Local and Central IRB submissions, including ICF review). * Transitioned regulatory tracking systems from manual processes to eTMF systems, Developed bridging SOPs to remain compliant with corporate SOPs which accommodated our unique division. * Ensured consistency across trials in storage of documentation, training and scheduling bi-weekly meetings with the study team to resolve issues. * Preparation for Investigator meetings for study launch. * Assisted Project Manager in various ad hoc projects such as developing a manual study/resource tracker for all trials. * Demonstrate working knowledge of clinical research conduct, regulations and standards, while complying with applicable company SOP's and policies. * Producing high quality clinical evidence by improving trial execution to generate the data that can be submitted for safety and product approval. * Support development of clinical study plan and provide feedback and user acceptance testing on CRF development. Experienced with problem solving, analytical skills, multitasking with attention to quality accuracy and compliance to prevent repetitive work resulting in time/money costly savings. * Ability to initiate assigned tasks and work independently while assisting on multiple projects with effective communication skills and organization. * Capability to establish and maintain effective working relationships with clients, management and coworkers. * Quality assurance support, auditing techniques, with effective communication and organization.

Highlights:

• Documentation
• Management
• Data Management
• Budgeting
• Clinical Operations
• Clinical Research
• Collection
• Compliance
• Contract Negotiations
• Distribution