Kristen Bauer Email & Phone Number

Bethesda, Md, Us

Bethesda, Md, Us

Global 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.

Tucson, Arizona, Us

Primary 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.

Indianapolis, Indiana, Us

Provide 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.

Raleigh, North Carolina, Us

Responsible 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

Berlin, De

Regional 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.

Berlin, De

In-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.

Berlin, De

In-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.

Indianapolis, In, Us

Assisted 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.

Bloomington, Indiana, Us

Clinical 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

Indianapolis, Indiana, Us

Performed 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

Responsible 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