Tamara Deleon Email and Phone Number

Clinical research consultant providing medical writing, clinical trial management, and clinical monitoring services to the medical device and pharmaceutical industry.

Responsible for the development and management of clinical study programs to obtain FDA approval of investigational orthopaedic medical devices, as well as outcome studies for marketed devices. Specific responsibilities included: *Department head for the Clinical Research Dept.*Preparation of FDA submissions (IDE, PMA)/pre-IDE meetings*Overseeing clinical study budget ($1.2 million budget)*Consulting to subsidiary companies regarding clinical-related matters*Presentations to senior management on clinical project status*Hiring, training, and supervision of clinical monitors*Intimate working knowledge of FDA regulations governing medical device studies

Responsible for the development and management of clinical studies conducted to obtain FDA approval for medical devices. Specific responsibilities included:*Preparation of clinical protocols*Interactions with surgeons/biostatistician/engineers/marketing to develop study protocols*Clinical investigator selection, enrollment, and training*Revision of departmental procedures*Supervision of monitoring activities of clinical monitors

Responsible for daily operations of FDA-regulated medical device trials. Specific responsibilities included:*Managing/training of clinical research specialists*Preparation of FDA submissions (IDEs, PMAs, progress reports, final reports)*Clinical monitoring of over twenty investigational sites across the U.S.*Preparation for GCP compliance audits*Development/implementation of blinded radiographic evaluation*Received a quality award for work on the Collagraft PMA

Responsible for the conduct of clinical investigational sites to assure that all studies conform to the FDA regulations. Specific responsibilities included:*Maintaining extensive study records and patient files*Conducting on-site monitoring visits*Administration of study payments*Planning annual investigators' meeting

Responsible for monitoring clinical and nonclinical studies to assure that research meets FDA regulations. Specific responsibilities included:*Writing clinical protocols/designing case report forms*Presenting study protocols to study investigators*Monitoring medical records to verify study data

Responsible for detailing cardiovascular/respiratory pharmaceuticals to cardiologist and internists.

Responsible for patient care involving respiratory therapy and emergency room treatment.