Director Resume Example
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DIRECTOR
Experience
Director | 01/2013 to Current
Biznow - Denver , CO
Biznow - Denver , CO
- Lead and manage operations of innovative Robotics Competition program that enhances educational opportunities in science, technology, engineering, and mathematics (STEM).
- Direct the collection of data and metrics for our programs.
- Develop and implement community outreach initiatives to grow awareness and build advocacy for program with local business leaders.
- Assist students in developing critical thinking and problem solving skills for real-world problems.
- Create and execute community-based fundraising campaigns.
- Perform program planning and curriculum development, write and submit grant applications.
- Recruit and manage industry professionals who serve as mentors in the program.
- Identified risks and develop mitigation plans.
- Set and oversaw yearly $[Amount] budget to cover [Number] hours of new station programming.
- Improved success of the program by making proactive adjustments to operations.
- Provided ongoing direction and leadership for program operations.
- Developed [Type] program from theground up, laying out framework and defining roles.
Clinical Research Manager | 01/1992 to 01/1994
Eden Technologies - White Plains , NY
Eden Technologies - White Plains , NY
- Built and led a newly formed clinical research department for start-up biotechnology company.
- Developed and implemented all operational policies and SOPs for the department.
- Monitored multi-site Phase III clinical trials on tissue regeneration technologies for periodontal and diabetic wound repair in accordance with FDA, ICH, and GCP guidelines.
- Hired, trained, and managed Clinical Research Monitors and Clinical Data Associates.
- Performed site initiation, interim monitoring, and close-out visits.
- Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
- Followed informed consent processes and maintained records.
- Collected, evaluated and modeled collected data.
- Coordinated clinical trials focused on disorders such as [Name] and [Name].
- Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Reviewed data queries and listings and worked with study centers to resolve data discrepancies.
- Followed drug storage procedures to comply with protocols and SOP requirements.
- Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
- Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
- Promoted awareness of project-specific quality and performance standards to support documentation, communication and understanding.
- Interfaced with clinical investigators and site staff to foster ethical research consistent with research plans.
- Maintained site monitoring schedules to facilitate effective communication with members of clinical team.
- Gathered and organized clinical trial documentation to meet rigorous standards for site approval.
- Assisted in investigator selection and qualification process to provide capable investigators with adequate resources to properly conduct trials.
- Set up and disbanded trial study centers to manage clinical study activities for [Number] sites.
- Leveraged [Type] knowledge, expertise and problem-solving techniques to resolve investigative site issues.
- Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
- Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity.
- Monitored safety of human subjects and oversaw consent procedures to comply with local and federal regulations.
- Submitted routine [Type] reports and follow-up letters to facilitate internal and external communication.
Clinical Research Associate | 01/1987 to 01/1992
Acutus Medical, Inc. - Milwaukee , WI
Acutus Medical, Inc. - Milwaukee , WI
- Coordinated and managed the conduct of multi-site Phase III CNS and infectious disease studies in strict accordance to study protocol, SOPs, GCPs, and regulatory guidelines.
- Authored three study reports and prepared an NDA and two FDA Safety Updates.
- Collaborated with colleagues in England on international studies.
- Selected by the Director to work on the patient narratives regarding Adverse Events.
- Performed site initiation, interim monitoring, and close-out visits.
- Trained internal Pfizer and contracted Clinical Research Associates (CRAs).
- Served as a liaison between Pfizer and the CRO contracted for studies.
- Conducted study initiation, interim monitoring, and study close-out visits.
- Monitored site performance and collaborated with investigators to resolve study related issues.
- Participated in protocol development for studies.
Education
University of Miami - City, State | B.AApplied Psychology, General Psychology/Neuroscience
Queens College - State
Summary
Results-driven clinical research professional with more than eleven years of experience managing Phase II-III industry-sponsored clinical trials across multiple therapeutic areas. Highly organized with demonstrated ability to build clinical research departments and non-profit organizations from the ground up. Well-versed in all aspects of study conduct, including FDA, ICH, and GCP guidelines in both pharmaceutical and biotechnology environments. Therapeutic expertise in the areas of wound care, CNS, metabolic, and infectious diseases.
Highlights
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Resume Overview
School Attended
- University of Miami
- Queens College
Job Titles Held:
- Director
- Clinical Research Manager
- Clinical Research Associate
Degrees
- University of Miami - City , State | B.A
Queens College - State
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