Kristen Bauer Email and Phone Number
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With over 26 years of experience in clinical research, I also hold a specialized B.S. degree in Health Sciences/Clinical Research Administration from The George Washington University School of Medicine and Health Sciences. Currently, I am a Global Project Director at Precision for Medicine, a leading contract research organization that provides specialized services for innovative life sciences companies. As a Global Project Director, I am responsible for the planning, implementation, execution, and management of clinical research studies across multiple therapeutic areas. I oversee the operational and fiscal activities of the project, such as budgets, milestones, cross-functional team leadership, vendor selection and oversight, and quality and compliance. I also participate in business development activities, such as RFP, RFI, bid defense meetings, and vendor qualification. I have extensive experience in drug phases I-IV, diagnostic and medical device research trials, including IDE, post-market, and after market/pre-approval, and medical affairs activities, such as expanded access, compassionate and emergency use. I have successfully managed clinical research projects on six continents, working with diverse stakeholders, regulatory agencies, and site staff. I am passionate about mentoring and training, and I regularly provide clinical research education for site support staff, medical staff, CRAs, technical field staff, and other colleagues. I am also a proficient public speaker, and have presented at various conferences and events.
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(Global) Project Director, Project ManagementPrecision For Medicine Jul 2023 - PresentBethesda, Md, Us
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(Global) Senior Project ManagerPrecision For Medicine May 2018 - Jul 2023Bethesda, Md, UsGlobal Project Management responsible for the planning, implementation, execution and management of clinical research studies. Management of the operational and fiscal activities of the project including: staffing, budgets and milestones as defined in the scope of work of the project, and cross-functional team leadership. Rare disease, Oncology, CNS, drug, device and diagnostic research.
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(Global) Study Manager, Medical AffairsVentana Medical Systems/Roche Tissue Diagnostics May 2015 - May 2018Tucson, Arizona, UsPrimary study management responsibility and actively participates on cross-functional project teams responsible for the development and scientific research of in vitro diagnostics, companion diagnostics, primary staining, advanced staining and digital pathology products on six continents. Manages day-to-day activities of all aspects of clinical studies, Testing Access Readiness Programs (TARP), Compassionate Use programs, etc in areas including study plans, monitoring plans, timelines, resources, vendor management, problem identification and resolution, status reports and budgets to ensure timely delivery of completed study deliverables. Assists in the development of supported (Investigator Initiated Studies) and sponsored studies, including the development of protocols, informed consent documents (as appropriate), case report forms (CRFs), and data collection and review. Oversees the site approval, start-up, maintenance, and close-out processes with respect to contract review, critical document and reporting requirements and ICH/GCP, in conjunction with project team. Provides oversight and direction to project team members and study staff for study deliverables; including training as needed. Oversees management of Clinical Research Associates and Clinical Trial Assistants. Manages the development and implementation of improved processes for execution of internal and external studies within the Ventana Quality System. -
Senior Clinical Project ManagerConcentrics Research, Llc (3 Month Dedicated Contract Via Volt) Dec 2014 - Mar 2015Indianapolis, Indiana, UsProvide Senior level project management on Phase II-IV Clinical Trials and RX to OTC Switch Market Research trials, Interview and choose qualified sites for studies, Conduct Site Initiation Visits, Plan and execute Investigator Meetings, Provide on-site training to sites, Participate with Upper Management on Client Strategy and Feasibility Meetings, Review Monitor reports including Pre-study visit, Site Initiation Visit, and Interim Monitoring activities, Develop monitoring plans, Lead Monitor on Actual Use Study; Identify, interview, hire and train contract monitors, Responsible for ensuring clinical studies are conducted in accordance with client specifications and global, federal, internal and local guidelines, SOPs, and regulations, Mentor junior project managers and associate project managers, Manage cross-functional project team as well as external vendors, Oversee budget adherence. -
(Global) Medical Quality Representative - Biomedicines, Eli LillyInventiv Health Clinical (Dedicated Contract To Lilly) May 2014 - Nov 2014Raleigh, North Carolina, UsResponsible for ensuring clinical processes are conducted in accordance with global, federal, internal and local guidelines, SOPs, and regulations, Developed, performed, and managed quality assurance activities, Provided quality support to study teams developing and conducting pharmaceutical phases I-IV and device clinical trials on a global level in the therapeutic areas of bio-medicines and diabetes, Assumed a lead role for the preparation, conduct, and responses to regulatory agency as well as internal company inspections, Provided leadership and strategy in line with global strategic objectives, Participated in sponsor mock regulatory inspections -
Senior Regional Clinical Research AssociateBiotronik Jul 2012 - May 2014Berlin, DeRegional monitoring position with monitoring responsibilities in both Cardiac Rhythm Management (CRM) studies as well as Vascular Intervention (VI) studies. Serve as Lead CRA for VI studies as a liasion between in-house group and regional group. Develop, teach, organize, and oversee a basic research course given to customers with coordinators who have 2 years or less of research experience. Mentor new or junior regional CRA's in department. -
Senior Clinical Research AssociateBiotronik Mar 2009 - Jul 2012Berlin, DeIn-house position with additional regional monitoring responsibilities in both Cardiac Rhythm Management (CRM) studies as well as Vascular Intervention (VI) studies. Experienced in protocol development, site selection/training/initiation, start-up, maintenance and close out of IDE, post-market, and after-market studies. Am also heavily involved in departmental and company wide training development, both in person and online teaching courses. Develop, teach, organize, and oversee a basic research course given to customers with coordinators who have 2 years or less of research experience. Mentor junior CRA's in department, and assist management with designing and developing new procedures and policies. Review monitor reports and oversee scheduling site visits for the west coast region.
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Clinical Research Associate IiBiotronik Jun 2007 - Mar 2009Berlin, DeIn-house position with additional regional monitoring responsibilities. Lead CRA responsibilities on various IDE, Post Market, and After Market Clinical Trials in the area of Cardiac Rhythm Management (CRM) devices. Also provided input on process development, mentoring and education of junior CRAs in the department, and well as general clinical research education to site personnel.
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Clinical Research Outreach CoordinatorIndiana University School Of Medicine Nov 2005 - May 2007Indianapolis, In, UsAssisted over 1000 Investigators and Coordinators in designing and implementing subject recruitment strategies in an academic setting. Created a centralized public volunteer registry listing for enrolling clinical trials on campus. Represented Indiana University School of Medicine in outreach efforts by promoting and educating the public about the clinical research process. Assisted in organizing and teaching bi-annual clinical research courses to new coordinators on campus. -
Clinical Research Coordinator, OrthopaedicsIndiana University Apr 2005 - Nov 2005Bloomington, Indiana, UsClinical Research Coordinator for Total Hip Replacement Device Research, Researched and prepared presentations for international audiences on research data, Participated in medical writing for publications, Coordinated research seminars for surgeons and radiologists -
Clinical Technical Research AssociateEli Lilly (Medfocus Contract) Feb 2003 - Dec 2004Indianapolis, Indiana, UsPerformed clinical operations within osteoporosis platform research, including developing new protocols, informed consents, site initiation and closeout. Participated in FDA submission activities such as writing one page patient summaries, performing quality checks on Clinical Study Reports, and collecting regulatory IND documents. Created and approved advertising for patient recruitment tools -
Clinical Research CoordinatorUrology Of Indiana 2002 - 2003Responsible for patient recruitment, clinical procedures, data collection, and IRB. Created and implemented standard operating procedures for research department, Formulated strategies to increase research referrals within a multi-location practice and Increased recruitment opportunities by speaking at public outreach seminars
Kristen Bauer Skills
Kristen Bauer Education Details
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The George Washington University School Of Medicine And Health SciencesClinical Research Administration
Frequently Asked Questions about Kristen Bauer
What company does Kristen Bauer work for?
Kristen Bauer works for Precision For Medicine
What is Kristen Bauer's role at the current company?
Kristen Bauer's current role is Global Project Director @ Precision For Medicine | Clinical Research.
What is Kristen Bauer's email address?
Kristen Bauer's email address is kr****@****oud.com
What schools did Kristen Bauer attend?
Kristen Bauer attended The George Washington University School Of Medicine And Health Sciences.
What are some of Kristen Bauer's interests?
Kristen Bauer has interest in Poverty Alleviation, Education.
What skills is Kristen Bauer known for?
Kristen Bauer has skills like Electronic Data Capture, Investigational Device/drug Reconciliation, Project Management, 510k/pma Submission, Ind/ide Experience, Irb, Informed Consent Development, Protocol Development, Monitoring, Microsoft Office, Mac, Clinical Research Education.
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