Melissa Brasher
Knoxville,TN
Summary
Clinical Operations Manager with over 12 years of experience driving productivity, streamlining workflows, and leading high-performing teams across diverse therapeutic areas. Proven expertise in clinical trial management, regulatory compliance, and EHR utilization, with a strong focus on quality, efficiency, and patient outcomes. Skilled in building trusted relationships with physicians, site staff, and executive stakeholders, delivering complex information with clarity, and resolving challenges to keep projects on track. Recognized for strategic leadership, problem-solving, and communication skills that consistently contribute to seamless operations and successful project delivery.
Overview
13
13
years of professional experience
Work History
Clinical Operations Manager
Thermo Fisher Scientific
Knoxville, USA
03.2024 - Current
- Oversaw daily management of team, achieving operational efficiency across projects.
- Served as a leadership role model for CRAs, CTCs, RSMs, and clinical staff.
- Provided coaching and development support to enhance team capabilities and performance.
- Managed effective resourcing, alignment, training, and ongoing professional development initiatives.
- Collaborated with senior management on strategic planning and business development initiatives.
- Acted as escalation point for performance concerns and training needs to uphold SOPs.
- Led a team of 12 CRAs across therapeutic areas, facilitating communication between sponsors, site staff, and executive leadership.
- Presented project outcomes and performance metrics to leadership and clients, showcasing strong executive communication skills.
Clinical Team Manager
Thermo Fisher Scientific
Knoxville, USA
06.2022 - 03.2024
- Directed clinical deliverables across multiple global trials, ensuring adherence to timelines and quality standards.
- Forecasted and reconciled clinical budget, identifying out-of-scope tasks with Project Lead and Sponsor.
- Initiated project-level clinical deliverables, maintaining resources and quality throughout processes.
- Developed functional project plans and tools, establishing necessary system setups.
- Led monitoring strategy development, addressing potential risks with effective solutions.
- Utilized available data sources to proactively identify emerging risks in clinical projects.
- Collaborated with Project Lead and stakeholders to prepare and present at internal and external meetings.
- Provided project-specific training and leadership to the clinical team, fostering motivation and achieving goals.
Principal Clinical Research Associate
Thermo Fisher Scientific
Knoxville, USA
04.2022 - 06.2022
- Supervised clinical activities of CRAs, ensuring timely delivery of project objectives.
- Managed over 20 clinical trial sites across North America, fostering strong investigator relationships.
- Conducted routine site monitoring, reviewing informed consents and regulatory files.
- Delivered training to site personnel, enhancing compliance and enrollment rates.
- Collaborated with physicians and site staff to provide protocol and system usage training.
- Supported FDA inspections and sponsor audits by maintaining accurate EHR documentation.
- Mentored junior CRAs, guiding them on project tasks and monitoring report reviews.
- Assisted Clinical Team Managers with large multinational studies to streamline project execution.
Senior Clinical Research Associate
Thermo Fisher Scientific
Knoxville, USA
07.2020 - 04.2022
- Coordinated site management for projects, ensuring compliance with ICH GCPs and FDA guidelines.
- Conducted routine monitoring visits to evaluate protocol adherence, regulatory compliance, and investigational product accountability.
- Established and maintained collaborative relationships within medical research community and client personnel.
- Supervised clinical activities of CRAs, assisting Project Lead with clinical deliverables and project coordination.
- Mentored junior Clinical Research Associates through co-monitoring and training initiatives.
- Led clinical team efforts to achieve project goals and meet critical deadlines.
- Performed site initiation, monitoring, and closeout visits while reviewing patient data in EHR systems.
- Collaborated with site staff to ensure accurate reporting of safety events and protocol adherence.
Senior Clinical Research Associate
ICON
Knoxville, USA
08.2019 - 07.2020
- Completed on-site and remote site evaluations, ensuring timely data retrieval and reporting.
- Attended virtual Investigator Meetings to maintain alignment with study protocols.
- Conducted thorough reviews of regulatory files to ensure compliance.
- Reviewed informed consents, adverse event reporting, and investigational product accountability.
- Monitored data using clinical systems such as IWRS and CRF paper/EDC.
- Maintained consistent communication with investigator sites via calls and emails.
- Performed case report forms review, generating and resolving queries per data management guidelines.
- Developed strong relationships with investigative sites, client personnel, and study vendors.
Clinical Research Associate II
Syneos
Knoxville, USA
10.2018 - 07.2019
- Conducted pre-investigational site evaluations, monitoring, and closeout visits, ensuring timely data retrieval and reporting.
- Reviewed regulatory files on-site to confirm compliance with industry standards.
- Assessed trial sites for adherence to protocols, GCP, ICH, and SOPs, delivering detailed findings reports.
- Evaluated informed consents and monitored AE/SAE reporting and investigational product accountability.
- Utilized clinical systems, including IWRS, EHR and CRF (both paper and EDC), for effective data monitoring.
- Contributed to client presentations and bid defenses to support business development efforts.
- Participated in investigator meetings and facilitated training sessions for study team members.
Clinical Research Associate
Thermo Fisher Scientific
Knoxville, USA
06.2016 - 09.2018
- Coordinated all site management tasks for assigned projects, ensuring compliance with ICH GCPs and FDA guidelines.
- Conducted routine monitoring visits to verify protocol adherence and investigational product accountability.
- Established and maintained collaborative relationships with sites and client personnel in medical research community.
- Supervised clinical activities of CRAs, assisting Project Lead in achieving project milestones and deliverables.
- Mentored junior Clinical Research Associates through co-monitoring and training initiatives to enhance skills.
- Played a key role in leading clinical teams to meet project objectives and deadlines effectively.
- Oversaw essential document reviews during monitoring visits, ensuring regulatory compliance throughout projects.
Lead Clinical Research Coordinator
PMG
Knoxville, USA
04.2014 - 05.2016
- Coordinated all aspects of clinical trial execution, including patient enrollment and scheduling.
- Performed comprehensive clinical activities such as vitals, ECGs, and laboratory collection.
- Administered study drugs while maintaining strict accountability protocols.
- Maintained and submitted regulatory documentation to ensure compliance throughout studies.
- Completed feasibility documents for study start-up processes.
- Created source documents in accordance with protocol requirements.
- Mentored and trained new research coordinators to enhance team performance.
- Forecasted staffing needs during vaccine trials to optimize resource allocation.
Radiologic Technologist
Tennova Medical Center
Knoxville, Tennessee
06.2012 - 04.2014
- Executed advanced diagnostic imaging procedures using specialized equipment.
- Collaborated with physicians to define patient imaging needs and protocols.
- Maintained precise patient records through electronic health records (EHR).
- Ensured adherence to safety protocols and radiation protection standards.
- Trained junior technologists on effective equipment operation and imaging procedures.
- Monitored patient comfort and safety throughout all imaging processes.
- Operated mobile imaging equipment for bedside, operating room, and emergency room applications.
- Processed digital images using PACS system for efficient storage and retrieval.
Education
B.S. - Health Science
South College
Knoxville, TN, USA06.2012
A.S. - Radiologic Technologist
South College
Knoxville, TN, USA06.2012
A.S. - Management
Roane State Community College
Knoxville, TN, USA05.2006
Skills
- Clinical trial management and project oversight
- Budget forecasting and financial planning
- Regulatory compliance and monitoring
- Performance metrics and data analysis
- Cross-functional collaboration and teamwork
- Risk assessment and mitigation
- Strategic planning and execution
- Attention to detail and accuracy
- Executive communication and reporting
- Problem solving and critical thinking
- Interpersonal communication and relationship building
- Market analysis and customer insights
References
References available upon request.
Timeline
Clinical Operations Manager
Thermo Fisher Scientific
03.2024 - Current
Clinical Team Manager
Thermo Fisher Scientific
06.2022 - 03.2024
Principal Clinical Research Associate
Thermo Fisher Scientific
04.2022 - 06.2022
Senior Clinical Research Associate
Thermo Fisher Scientific
07.2020 - 04.2022
Senior Clinical Research Associate
ICON
08.2019 - 07.2020
Clinical Research Associate II
Syneos
10.2018 - 07.2019
Clinical Research Associate
Thermo Fisher Scientific
06.2016 - 09.2018
Lead Clinical Research Coordinator
PMG
04.2014 - 05.2016
Radiologic Technologist
Tennova Medical Center
06.2012 - 04.2014
B.S. - Health Science
South College
A.S. - Radiologic Technologist
South College
A.S. - Management
Roane State Community College
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