Mary Hixson
Inventiv Health Inc.
FORTWAYNE,IN
17
years of professional experience
Business-focused clinical research leader with a strong background in data management, regulatory documentation, and inspection readiness. Known for coordinating site operations, mentoring staff, and improving study accuracy through disciplined quality control. Ready to support efficient, compliant, and high-performing research programs.
Work History
Senior Clinical Research Associate
10 Years 3 Months- Managed site initiation, routine follow-up, and closeout activities across assigned studies.
- Conducted site monitoring visits to verify source data, protocol compliance, and subject safety.
- Reviewed clinical trial documents for accuracy, completeness, and alignment with ICH-GCP standards.
- Documented monitoring findings and tracked corrective actions through CTMS and trip reports.
- Evaluated regulatory binders, essential documents, and informed consent files for inspection readiness.
- Escalated safety concerns and operational risks to study management for timely resolution.
- Implemented electronic data capturing systems to adhere with clinical research guidelines.
- Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity.
- Increased the accuracy of study data by implementing robust quality control measures during data review and analysis phases.
Senior Clinical Research Associate
2 Years 2 Months- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Coordinated with investigators and site staff to resolve data queries and protocol deviations.
- Communicated project status to Pharmaceutical management verbally and through technical documentation and presentations.
- Managed project risk by identifying, quantifying and monitoring potential threats.
- Maintained knowledge of company strategic direction, goals and objectives and aligned projects appropriately.
- Developed solutions by researching advanced technologies, methods for modeling and predicting performance outcomes and innovative approaches for personalized and adaptive user support.
- Reduced study timelines by effectively managing multiple concurrent clinical trials across various therapeutic areas.
- Supported regulatory submissions with comprehensive documentation preparation, leading to successful approval of investigational products.
- Developed strong relationships with investigators and site staff, fostering a culture of trust and open communication throughout the study duration.
Clinical Trial Manager
5 Years 3 Months- Led clinical trial operations, aligning protocol execution with IRB, GCP, and regulatory requirements.
- Managed cross-functional teams to maintain timely subject enrollment, data quality, and visit compliance.
- Oversaw study startup activities, including site readiness, document review, and investigator coordination.
- Directed regulatory submissions, amendments, and continuing review packages for active research protocols.
- Mentored research staff on protocol adherence, human subjects protection, and study procedures.
- Streamlined trial management processes for increased efficiency through diligent organization and coordination of resources.
- Supported the preparation of clinical study reports by providing accurate data analysis and interpretation for inclusion in final documentation.
- Improved data quality in clinical trials by overseeing data management activities such as data cleaning, validation, and database lock procedures.
- Fostered strong relationships with investigative sites, leading to increased collaboration and improved study outcomes.
- Facilitated clear communication between study teams, sponsors, and investigators to maintain alignment on project goals and expectations.
Education
Licensed Paramedic - Paramedicine
Skills
Data management
Site management
Data quality management
Leadership qualities
Data analysis techniques
Issue resolution
Team leadership
Protocol adherence
Medical terminology
Accomplishments
- Robert A. Kuschner, Kevin L. Russell, Mary (Abuja) Hixson, Kristen M. Bauer, Dennis J. Faix, Howard Hait, Jenifer Henrick, Michael Jacobs, Alan Liss, Julia A. Lynch, Qi Liu, Arthur G. Lyons, Mohammad Malik, James E. Moon, Jeremiah Stubbs, Wellington Sun, Doug Tang, Andrew C. Towle, Douglas S. Walsh, Deborah Wilkerson, and the Adenovirus Vaccine Restoration Consortium. A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of the SAFETY and Efficacy of Live Oral Adenovirus Types IV and VII Vaccines in U.S. Military Recruits: Vaccine. 2013 Jun 19;31(28):2963-71. doi: 0.1016/j.vaccine.2013.04.035. Epub 2013 Apr 25.
- Conducting a Large Randomized Trial in the Military Setting: Lessons for Implementation in the Civilian Setting. SOCRA Source Apr. 2012
- “Conducting a Large Randomized Trial in the Military Setting: Lessons for Implementation.” Aug 2009 - Force Health Protection Meeting, Albuquerque, MN, Poster
Publications and Presentations:
Timeline
Senior Clinical Research Associate
Inventiv Health Inc.
08.2014 - 11.2024Read More
Senior Clinical Research Associate
COVANCE LABORATORIES, a LabCorp Company
06.2013 - 08.2015Read More
Clinical Trial Manager
Naval Health Research Center
03.2008 - 06.2013Read More
Silver Cross Hospital
Licensed Paramedic from Paramedicine
Read More