Description
CURRICULUM VITAE: Sharon Woodruff Team excellence instructor, facilitator, and trainer. Proven managerial, interpersonal, and training skills. Work History Title: Senior Clinical Research Associate Company/Location United BioSource Corporation Kansas City, MO/Regional United States Dates July 2014 - January 2015 Accountabilities Implement and monitor clinical trials for medications and devices to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements, the FDA, and ICH-GCP guidelines. Ensure participant safety during clinical trials. Ensure all required training is completed and documented; provide training as needed. Manage and train assigned sites and ensure site compliance, adequate enrollment and understanding of study requirements. Function independently with minimal oversight required; remote employee. Title: Senior Clinical Research Associate Company/Location PRA, Raleigh, NC/Regional United States Dates November 2012 – July 2014 Accountabilities Implement and monitor clinical trials for medications and devices to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements, the FDA, and ICH-GCP guidelines. Ensure participant safety during the clinical trials. Ensure all required training is completed and documented; provide training as needed. Assess the qualification of potential investigative sites and their staff, initiate clinical trials at investigative sites, train/educate site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites. Work closely with clinical team members to facilitate timely resolution of clinical issues. Assess IP accountability, dispensation, and compliance at the investigative sites. Mentor junior level CRAs; Serve as observation and performance visit leader for training; Serve as a Preceptor for new CRAs. Serve as a resource for and interact with other functional areas to resolve site issues and facilitate trial timelines. May be assigned clinical tasks where advanced negotiating skills are required. When responsible for supervising other CRAs: Schedule and review trial tasks, provides leadership in the delivery of services to clients, ensure that staff fulfill their responsibilities in accordance with policies, procedures, and SOP's, and ensure HR processes are properly implemented. Function independently with minimal oversight required; remote employee. Present/train on study materials at Investigator Meetings. Title: Sr. Clinical Research Associate (Prompt Monitor)/Contractor Short Term Company/Location Kforce International Now a part of InVentiv Health, Tampa, Florida/Regional United States Dates February 2012 - November 2012 Accountabilities Complete remote/prompt monitoring for Pfizer trials exclusively. Worksheet completion, issue identification and issue escalation. Support the project management team. Short term contract. 100% remote employee; remote data review; 100% review of all collected trial data. Assist with company’s quality control initiative. Other duties as assigned. Presesnt to/train clinical staff on identified topics. Title: Sr. Clinical Research Associate Company/Location i3 Research, Now a part of InVentiv Health, Cary, NC Dates May 2010 - March 2012 Accountabilities Implement and monitor clinical trials for medications and devices to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements, the FDA, and ICH-GCP guidelines. Ensure participant safety during the clinical trials. Ensure all required training is completed and documented; provide training as needed. Manage assigned sites by regular contacts to ensure site compliance, adequate enrollment and understanding of study requirements. Function independently with minimal oversight required; remote employee. Ensure all required training is completed and documented; provide training as needed. Serve as backup for Regional Manager. Assist with company’s quality control initiative. Assist project management team with review of monitoring reports and study documents when required. Participate in the interview process of potential clinical staff candidates when required. Present study materials at Investigator/study launch meetings when required. Title: Sr. Clinical Research Associate/Contractor Short Term Company/Location Emory University, Atlanta, GA Dates January 2010 - April 2010 Accountabilities Audit Phase I and II Physician Initiated Oncology Trials. Assure site readiness for National Cancer Institute audit. Short term contract. 100% review of all collected data. Respond to queries from the Primary Investigators. Present clinical data issues to Primary Investigators (PI). Instruct Primary Investigators on FDA, GCP and ICH guidelines for the Physician (PI). Initiated sponsor oncology trials on site. Title: Sr. Clinical Research Associate Company/Location Novella Clinical, Durham, NC Dates November 2007 - February 2010 Accountabilities Implement and monitor clinical trials for medications and devices to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements, the FDA, and ICH-GCP guidelines. Ensure participant safety during the clinical trials. Ensure all required training is completed and documented; provide training as needed. Function independently with minimal oversight required; remote employee. Develop study specific informed consent form for review and approval by the Sponsor. Serve as backup for Regional Manager. Review monitoring trip reports, follow up letters, and phone contacts. Assist in preparation of protocols, electronic casereport forms (eCRFs), study manuals, and other study documents. Assist with arranging and attend Investigator Meetings for assigned studies; present/provide training on study specific information/training to investigators and study coordinators at the Investigator Meeting. Train study site personnel on the research protocols, study procedures and electronic data capture. Conduct field training for clinical study monitors. Title: Clinical Research Associate Company/Location INC Research, Raleigh, NC Dates January 2007 - October 2007 Accountabilities Review monitoring trip reports, follow up letters, and phone contacts for various projects including major breast cancer trials, CNS, Psychiatric and diabetic neuropathy pain trials. Manage 16 study sites for phase III psychiatric trial. Train study site personnel on the research protocols, study procedures and electronic data capture. Conduct field training for clinical study monitors and co-monitoring visits with study monitors on a global phase III pain trial 2007. Serve as backup for Regional Manager. Conduct job performance assessment of office and field-based clinical study monitors. Assist with facilitation of and attend Investigator Meetings for assigned studies; present study specific information to investigators and study coordinators at the Investigator Meeting. Participate in the interview process of potential clinical staff employee candidates when required. Assure adherence to Good Clinical Practice, investigator integrity and compliance with all study procedures as the demonstrator and observer for training purposes. Title: Manager of Course Development and Training Company/Location MedImmune Inc., Gaithersburg, MD Dates June 2005 - October 2007 Accountabilities Review monitoring trip reports, follow up letters, and phone contacts for various projects including major immunization, oncology and CNS trials. Assist Human Resources in developing people, including recruitment, retention and career development. Design and facilitate "New-hire" orientation for the Medical Organization. Positively impact the quality of the Medical Organization through interactions with people, processes and deliverables. Design, develop and facilitate training courses for the Medical Organization. Trained CRAs for certification facilitation. Trained CRAs including protocol training on oncology trials and for company flagship products. Present clinical portion of weekly Human Resource new hire orientation. Create and Facilitate all Team Excellence Training for the Medical Organization. Develop 4 training manuals as a remote employee from January 2007 – October 2007 per management approval of project. Assure adherence to Good Clinical Practice, investigator integrity and compliance with all study procedures as the demonstrator and observer for training purposes. Manage 2 training employees Title: Contract Trainer & CRA Company/Location Otsuka America, Rockville, MD Dates January 2004 - June 2005 Accountabilities Train on-site clinical staff for sites in US and Canada; On going education of site staff and review as needed. Monitored sites and developed the clinical process to insure site success. Maintain regulatory files and device accountability. Order supplies with contracted vendors and train site staff to do the same IVRS inquiry resolutions Perform site visits of all types for phase I, II, & III diabetic, pain, & device trials Recruited subjects at 5 sites. Coordinate and monitor all clinical aspects of research for five trials Title: Southeast Regional Director Company/Location Treatment Finders, Seal Beach, CA Dates November 2000 - December 2003 Accountabilities Conduct site initiation visits for 30 sites, interim visits as needed, and close out visits as needed.Monitor all types of clinical trials; assure adherence to Good Clinical Practice, investigator integrity and compliance with all study procedures as the demonstrator and observer (co-monitor) for training purposes. Hire and train 17 community outreach specialist and 6 new CRAs. Manage 22-community outreach specialist and 10 CRA’s in the southeastern region. Audit CRF’s to assure safety and regulatory requirement compliance for multiple pharmaceutical sponsored trials. Develop site and regional action plans. Educate the community, subjects, providers and staff on clinical trial benefits and risks, Continue education and training of site staff and direct reports. Community outreach and education of area legal authorities, jails, shelters, community action groups, health departments and NAMI groups on Psychiatric Clinical Trials. Increase patient recruitment and retention by 50%; Increased by 75%. Education Doctorate in Ministry in Christian Education Jacksonville Theological Seminary, Jacksonville, FL Master of Ministry in Christian Education Jacksonville Theological Seminary, Jacksonville, FL Bachelor of Arts in Business Administration with emphasis on Healthcare Administration Webster University, St. Louis, MO Diploma Practical Nursing, St. Mary's School of Nursing, Clayton, MO Licenses, Certifications & Affiliations American Society of Training & Development, American Society of Training & Development, July 2005 Georgia SoCRA Chapter, Society of Clinical Research Associates (SoCRA), November 1998 Georgia State Practical Nursing License thru March 2007, #P044362
Accomplishments
Highlights:
Keywords
