anne flanagan

Detail-oriented and highly organized Clinical Research Professional with experience in a variety of disease states as well as medical device clinical trials. Committed to advancing medical knowledge and improving patient care through innovative and ethical research methodologies. Hoping to expand my management of clinical trials.

Health Research of Oklahoma                       3 yrs.-Present

-Lead Clinical Research Coordinator/Registered Dietitian participating in contract/budget negotiations for medical device and autoimmune clinical trials

-Conducted/ensured completeness of essential regulatory docs from study start-up through close-out

-Prepared regulatory submissions/supporting documents for IRB review and sponsor records

-Communicated deviations from protocol, SOPs, &/or GCP to the PI, Sponsor, and if required, IRB while taking appropriate action to prevent recurrence

- Contracted and coordinated with off site facilities for various trial required tests

-Maintained IMP accountability: storage, inventory, return/destruction and dispensing/receipt records

- Performs essential document collection, review, maintenance, and close-out activities

-Created invoices and billed for invoiceable items

ThreeWire, Eden Prairie, MN                                          1 yr.

-Patient Recruitment Coordinator developing effective recruitment strategies and built strategic partnerships with physicians/nurses. resulting in 40% increase in participation

COR Clinical Research, LLC, OKC, OK                            8 yrs.

-Lead Clinical Research Coordinator/Registered Dietitian participating in over 100 Phase I – IV clinicals trials at fast paced/diverse disease research site

-Managed/coordinated up to 15 clinical research studies simultaneously demonstrating flexibility and adaptability

-Trained regulatory, recruitment, and trial coordinators

-Prepared for and participated in FDA inspections

-Completed Pulmonary Function Tests/Oral Glucose Tolerance Tests

-Performed phlebotomy, IV placement, lab processing

-Ensured AE/SAEs were reported appropriately, accurately, and in a timely manner

Master of Science                                                                 Environmental Sciences                                                            Oklahoma State University

Bachelor of Science                                                          Biological Sciences                                                                      St. Gregory’s University