Anne Flanagan Contact Info:

MS, RDN, CNPR Edmond, Oklahoma

ad1tzm@r.postjobfree.com

405-***-****

linkedin.com/in/anne-flanagan-b06bb41ba/

Results driven Clinical Research Professional with extensive experience managing clinical trials. Skilled in ensuring compliance with regulatory standards and maintaining accurate TMF/CTMS/EDC documentation. Proven communicator with ability to build strong relationships with study teams to achieve objectives. Looking for an opportunity to join an organization as a Clinical Research Associate to utilize my skills and experience in clinical research and project management EDUCATION:

Master of Science 2005

Environmental Sciences

Oklahoma State University

Bachelor of Science 2001

Biological Sciences

St. Gregory’s University

Registered Dietitian Nutritionist

Registration #: 952864 (CDR)

Certified National Pharmaceutical Representative

CNPR #: 605302014 (NAPSRX)

NIDA/CITI Program GCP Certified

IATA Biological Substances Transportation Certified Certified Clinical Research Coordinator (ACRP 2013) SKILLS:

- Clinical Trial Oversight

- Adherence to ICH/GCP Regulations

- 10 + years Research Experience

- Project Organization

- TMF/CTMS/EDC Maintenance

- Medical Device Background

- Time Management/Organizational Skills

- Medical Terminology

EXPERIENCE:

-Medical Devices -T2DM (Injection/Oral/Inhaled) -CVD/CHF

-HTN -A-fib -Atopic Dermatitis/ Psoriasis -Eczema

-Ulcerative Colitis/IBS -Insomnia -Fibromyalgia

-Gout -Psoriatic Arthritis -Spondylarthritis -Lupus

-COPD/Asthma -Diabetic Neuropathy -Erectile Dysfunction

-Osteoarthritis - Menopause -Rheumatoid Arthritis

-Obesity -Opioid Induced Constipation - Oncology

-DVT -GERD -Idiopathic Orthostatic Hypotension -Migraine Publications: Flanagan, A.M., Brown, J., Santiago, C., Aad, P., Spicer, L., Spicer, M. High-fat diets promote insulin resistance through cytokine gene expression in growing female rats. J of Nutr. Biochem. 2007.

WORK HISTORY:

Health Research of Oklahoma 3 yrs.-Present

- Lead Clinical Research Coordinator/Registered Dietitian for clinical trials involving autoimmune diseases

- Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials

- Coordinated protocols by organizing and prioritizing all activities associated with Phase II-IV studies

- Demonstrated excellent knowledge of ICH/GCP regulations

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

- Demonstrated ability to escalate issues appropriately

- Participated in feasibility, contract negotiation, and invoicing

- Provided training relevant to study specifications

- Demonstrated working knowledge of Microsoft Office applications, Clinical Trial Management Systems, IVRS/IWRS, and Electronic Data Capture platforms

- Reviewed site documents for completeness and accuracy for inclusion into the TMF

- Reviewed medical history, concomitant medications, adverse events, and provided medical expertise as required

- Participated in recruitment for clinical trials

- Participated in regulatory/IRB submissions

- Involved in maintenance of trial from start up to close out

- Conducted diet counseling

- Participated in cutting edge medical device clinical trials

* Time taken off for children

COR Clinical Research, LLC 6 yrs

- Lead Clinical Research Coordinator/Registered Dietitian involved in over 100 Phase II-IV clinical trials at fast paced/diverse disease research site

- Registered Dietitian for obesity and T2DM studies

- Managed/Coordinated up to 12 clinical research studies simultaneously demonstrating flexibility/organizational skills

- Trained regulatory, recruitment, and trial coordinators

- Completed PFT/OGTT and other procedures assigned to protocol

- Prepared for and participated in FDA audit

- Communicated with sponsor, CROs, and CRAs to ensure essential documents/training was up to date

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