Luke Evan Jaeger

Business Address: 2765 Greeley St, Schenectady NY 12304 Phone: 845-584-0744 – Email: Luke@Luke-Jaeger.com

Summary: Research and Quality professional with successful work experience and academic achievements seeking to leverage skills in Good Clinical Practice (GCP), inter-person relations, organizational control, information management, records administration, GCP and quality assurance.

Relevant Experience

Clinical Trial Associate, 9 Meters Biopharma, Inc. (Remote) (12/2019 to 3/2023) The roles and responsibilities for the position are defined by the supervising manager and included but not limited to the following:

• Assisted in quality assurance and regulatory activities for ongoing clinical studies including quality compliance checks and records management.
• Assists in the preparation and drafting of GCP & GMP SOPs and related forms;
• Supports TMF record management activities including data QC verification.
• Assists with quality assurance internal audit of IP for closed sites (2019-2020), manage data summary review and prepared draft report;
• Provide IRB (Ethics Committee) submission support including approval tracking.
• Managed quality assurance GMP/GCP & Vendor audits;
• Manage Site Closeout (COV) activities for inactive sites including IP reconciliation & Disposition;
• Attend clinical team meetings;
• Assist in study diary data reconciliation review of assigned EDC clinical data.

President, Principle Consultant

Evolving Efficient Solutions, E. Jewett, NY (1/2018 – present) Wide range of consulting services provided includes partnering with clients from start to finish in the planning, implementation, and maintenance of their personal/business needs.

Quality Business Support Specialist, Synergy Pharmaceuticals, NY (summer 2012 – 2014, and summer 2015 – December 2015)

• Assisted in quality assurance activities for clinical studies including data reviews and records management.
• Participated in remote vendor qualification audit
• Organized and set-up Archive Room (paper and electronic files), reviewed clinical study TMF files for inventory / tracking as well as off-site long term storage, conducted quality data reviews and verification checks of study reports of electronic report to paper copies.
• Conducted medical search specialized indication
• Catalog final study report for archiving – QC verification of paper to CD electronic nonclinical report
• Review clinical trial data for consistency and accuracy
• Assist in document preparation for clinical and regulatory support (regulatory inspection readiness)
• Review financial invoice for reimbursement
• Attended & Completed Webinar training:
  • Required Electronic Submissions: eCTD and Study Data” – CDER Small Business & Industry Assistance (SBIA) webinar
• Attended & Completed Oriel Stat A Matrix Certifications in:

Luke Evan Jaeger

• Quality Systems, Risk Management and Analysis for Medical Devices,
• Design Control Concepts and Implementation (GMP)
• Attended & Completed Barnett Educational Services:
  • Good Clinical Practices (GCP) – A Foundation for the Responsible Conduct of Human Subject Research

Graduate Assistant to Director of Graduate Programs at Alfred University (August 2016 – May 2017)

• Assisted in researching new programs and courses at Alfred University: Planned a remodel of old classrooms to be used for new classes. Created the framework for a new minor for the Dean.
• Engaged in grading and creating study materials for students: Utilized MS excel to create matrices to detect cheaters
• Assisted in daily activities including day planning and everyday tasks.

Skills & Qualifications

• High Business awareness and client focused – capable of fast pace learning.
• High computer affinity advanced MS Office knowledge and intranet & internet.
• Good written and spoken English.
• Excellent interpersonal skills, discretion, tact, reliability, ability to communicate effectively at all levels, maintain confidentiality and adaptable to change.
• Thrive in a challenging, stimulating work environment; able to work independently and/or with minimal supervision.
• High working standards and self-motivated professional.
• Flexible and able to interact well within a team setting.
• Good attention to detail, excellent planning and organization skills including time management.

Education

Alfred University, Alfred, NY

• Major: Master of Business Administration (GPA 3.9)
• Focus: Sustainability

Alfred University, Alfred, NY

• Major: B.S of Science: Biomedical Materials Engineering and Sciences
• Minor: Chemistry

Academic Coursework

Business

Fundamentals of Business Management, Financial Accounting, Microeconomics, Macroeconomics, Statistics, Entrepreneurship, Healthcare Policy, Strategic Management, Global Leadership, Managerial Ethics.

Engineering

Completion of the Engineering courses required a basic understanding of Python which was supplemented with Computer Science coursework. Varied lab instruments and machines required training and attention to detail. Strict procedures must be followed increasing proficiency in these areas.

References – Upon Request

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