Responsible for management and oversight of clinical studies within our portfolio. Project management support for our first Investigator Initiated IDE. Assist in the hiring of key team members for a rapidly growing team. Facilitate planning, design, and execution of clinical studies. Manage timelines and study budgets. Work cross-functionally to ensure timely study and site startup, proper study conduct, timely study completion, data analysis, and appropriate reporting of clinical trials. Ensure timely development of study related plans and documents. Participate in identifying, selecting, and monitoring the performance of clinical sites. Facilitate EDC set-up by contributing to case report form design, performing user acceptance testing, and development of study worksheets.

Responsible for management and oversight of the global CRA/Operations team and ensure that our SOPs and other clinical study processes are consistent with good clinical practice and applicable rules and regulations across all business units. Working to build our European clinical operations team to oversee the multitude of projects we have planned for Europe in the coming years.

Remotely manage a US and International team. Manage US and International clinical studies. Responsible for study team leadership for our First in Human, Early Feasibility, Post Market, and Sham controlled IDE Pivotal Clinical Trials. Interview and hire key team members for a rapidly growing team. Facilitate planning, design, and execution of clinical studies to assess the safety and effectiveness of our company's products. Manage timelines and study budgets. Work cross-functionally to ensure timely study and site startup, proper study conduct, timely study completion and data analysis, and appropriate reporting of clinical trials. Ensure timely development of study related plans and documents. Participate in identifying, selecting, and monitoring the performance of clinical sites. Facilitate EDC set-up by contributing to case report form design, performing user acceptance testing, and development of study worksheets. Vendor oversight. Core lab oversight. International CRO management and oversight.

Responsible for clinical study initiation for a small medical device company with less than 20 employees. Responsibilities include: Assist small clinical team with site start-up and initiation/activation activities for an Early Feasibility and Pivotal clinical trials and close out of the First in Man trials. Clinical site management. Conduct database preview testing as well as UAT testing for a new database vendor. Design study worksheets. Review and edit many study regulatory documents such as the Site Monitoring Plan and Safety Plan, etc. Review and edit clinical SOPs. Assist in the development of a TMF as well as assist in the initiation a new eTMF system. Train end users on EDC and eTMF systems. Conduct many other duties in accordance with clinical trial implementation. Continuously support clinical management in the proper execution of the clinical trial.

Grateful U.S. Naval Veteran, loving mother of 4, and married to my best friend, a U.S. Air Force Veteran and multiple patent awards recipient. I have been privileged to have career mentors who have supported me throughout my career. Clinical Research Consulting allows me to do what I love and share what I've learned with teams all across the U.S., Canada, Australia, South America, and Europe. Able to work successfully in a remote environment.Experience in conducting all types of industry sponsored pharma and medical device clinical trials as well as investigator initiated trials. Experience includes: Manage OUS sites as well as US sites. New site start-up, initiation, and activation. Manage contract and budget negotiations. Train clinical site personnel. Mentor study team members. Private Practice Site management. Clinical study management. CRO, vendor and core lab oversight. Clinical Safety Specialist duties. Database UAT testing, assist with database design, and develop data worksheets for clinical sites. Clinical Monitoring. ACRP certification (over 20 years).

Manage clinical site activities, core lab activities, multi-national patient pre-screening/selection meetings and training for 20 sites in Germany, Spain, Israel, the Netherlands, the UK, Italy, Canada and the US. Coordinate all clinical site start-up activities including site qualification, initiation and activation for CE Mark and Early Feasibility trials. Facilitate contract and budget negotiations. Collaborate with CEC, DSMB and internal safety team for ongoing adverse event review and reporting. Conduct clinical database preview testing and UAT testing. Assist with CRF creation. Coordinate site monitoring activities, review and finalize reports, track and trend action items and meet regularly with CRO and field monitors.

CSS - Process, review, evaluate and track adverse events for ongoing clinical trials in the U.S., Europe and Japan. Cross functional collaboration with Regulatory Affairs, Clinical Operations and Field Assurance to ensure compliance with applicable regulations. MEDDEV reporting. Coordinate and lead CEC activities for a remote team of adjudicators and a local team of adjudicators. Assist with DSMB activities. Write and review event narratives.CRA-II - Manage clinical investigative sites and collaborate with IRB's to ensure compliance through on-going site management, clinical monitoring and site personnel training. Meet with and collaborate with field monitors to ensure consistency in monitoring practices. Review, write and finalize site visit reports.

Clinical Study Manager for 10 U.S. IDE clinical trial sites and CRA for 23, in addition to being the in-house CRA for 15 European post-market clinical trial sites. Managed all aspects of clinical site start-up phase including negotiating contracts and budgets. Performed clinical site qualification, initiation and activation visits. Conducted in-house and field clinical monitoring. Assist with CEC activities.

Managed the clinical research department for a busy Urologic private medical practice with several highly recognized KOL's. Medical device, phase III pharma, post-market, Investigator initiated and registry clinical trials. Collaborated with cross-functional teams from 7 metro area clinic locations for successful trial outcomes.

Obtained certification in clinical research. Coordinated Gastroenterology and Hepatology phase II and III pharma clinical trials. Reinvigorated clinical research partnership in the East Metro clinic locations.

Naval Instructor, EMT, EVOC-I, BLS-AF-IT-I, ACLS, and Leading Petty Officer to busy Urgent Care Clinic. 2 Navy Commendation medals, several Commendation Awards, Navy League Junior Outstanding Sailor of the Year.