Rose Morton Email & Phone Number

Greater San Diego Area

Greater San Diego Area

Greater San Diego Area

Focus on Phase 3/4 Double Blind Rheumatoid Arthritis Therapeutic StudyOncology Studies- Site Qualification and Remote Data Monitoring

San Diego

Collection Site Monitor for U.S. IVD clinical studies:- Responsible for ensuring that clinical investigative sites: protect the subjects rights and safety, adhere to clinical protocols, Standard Operating Procedures, ICH guidelines, Good Clinical Practices and FDA guidelines-Conduct Site Initiation, Routine Monitoring and Site Close-Out Visits-Review regulatory documents, informed consent forms, Case Report Form source document verification and prepare site visit reports-Assist in collecting data management queries and data clarification forms- Investigational sites first line of support for study related activities such as supply shipment, central and local Institutional Review Board activities, and all study-related questions- Work closely with sites on recruitment/advertising strategies in an effort to increase study enrollmentIn-House Site Monitor on a Flu specimen collection program to collect over 3000 specimens from 3 hospitals:- Primary site contact for collection site questions and protocol clarifications- Review EDC database for missing data and work with sites to review and resolve EDC queries- Request source documents from sites and perform remote source data verification of case report forms - Create case report form completion instructions and specimen collection worksheets

San Diego, Ca

Assist in the execution of U.S. diagnostic clinical trials including:- Effectively communicating with the study team and all members of the Clinical Affairs Department- Managing clinical sample organization and storage- Ordering, tracking, sending appropriate study supplies to participating sites- Managing study Trial Master File to ensure all documents are appropriately filed and the files are audit-ready- Assisting Clinical Research Associates with in-house activities including remote source-data verification, sample test shipments, and TMF audits- Tracking study start-up documentation and enrollment progress throughout the study- Creating case report form, shipping, and specimen collection work instructions

Palo Alto, Ca

• Independently coordinated active clinical trials for the Biochemical Genetics department and presented research reports at the 2013 Stanford Mitochondrial Disease Symposium• Collaborated with investigators, research team and pharmaceutical sponsors to ensure compliance with study protocol and FDA regulations• Screened clinic schedules and recruited potential candidates to available trials• Demonstrated exceptional organization skills by implementing and maintaining an improved study database

La Jolla Ca

Clinical Trials Coordinator - La Jolla, CA• Coordinated twenty-two therapeutic breast cancer studies, assuring efficiency and regulatory compliance• Served as the main liaison for all patients involved in studies, scheduling all appointments and triaging all requests to appropriate medical departments· Collaborated with investigators, nurses, and other staff of the research team to coordinate all research procedures· Screened patients to determine eligibility for participation in studies· Collected, processed and shipped study-related biological specimens· Administered a variety of tests to participants, including assessments on adverse events and quality of life surveys· Ensured that all aspects of the studies are compliant with government and institutional regulations, including those related to protected health informationClinical Trials Assistant - November 2009 – June 2010• Assisted Breast Cancer Coordinators and Project Managers with planning and execution of clinical trials• Promoted to coordinator after only seven months of demonstrated success