Jamie Mehrer
Clinical Research Professional
League City,TX
Summary
A clinical research professional specializing in leading high performing to achieve holistic study success across multiple therapeutic areas.
Overview
12
12
years of professional experience
13
13
Certifications
Work History
Clinical Research Program Manager
Shriners Children's Hospital
2024.06 - Current
- Ensured regulatory compliance in a protected population by closely monitoring adherence to industry standards and guidelines throughout the study lifecycles
- Maintained professional education and development of team members
- Harmonization of multiple hospital departments to bolster research efforts
- Responsible for re-implementation of overall research program at Texas location
- Navigated study success from initial feasibility to beyond DBL across all study aspects
- Ensured study success through overall program management, study supervision, and staff training/mentoring
Clinical Operations Manager
ICON PLC
2021.12 - 2024.06
- Responsible for management of resources and resource projections to ensure project teams are consistent with client needs, expectations and contractual expectations
- Provides leadership and implement Clinical Operations services and productivity improvements to ensure optimal utilization of billable staff
- Serve as point of escalation for resolution of issues and conflicts
- Provides support with proposal development and participates in client presentations and/or bid defense meetings
- Lead international team of study start up specialists to ensure study success in key cycle metrics including risk analysis/mitigation at portfolio level
- Serve as subject matter expert for key stakeholder in country regulatory requirements and associated study start up impacts from feasibility to activation
- SME knowledge inclusive of Mexico, United States, Canada, Chile, and Puerto Rico
- Data driven feasibility assessment at both country and portfolio levels
- Daily utilization of internal technology platforms in analysis of direct report and study metrics
- Provide input on study related documents (e.g ICF, CRF, monitor plan, protocol, study Procedure Manual etc.), set-up and maintain study files.
- Reduce project timelines for successful clinical trials by effectively managing resources and maintaining clear communication with stakeholders
- Responsible for hiring, training of team members, evaluating staff performance and leading resolution of issues with clinical study
- Manage cross-functional teams, resulting in seamless collaboration and increased productivity in clinical projects
- Facilitate strong relationships between sponsors and internal teams through regular updates and effective communication strategies
- Develop comprehensive training programs for new hires, ensuring high level of competency within team
- Promote high morale and staff retention through dynamic communication, prompt problem resolution, proactive supervisory practices and facilitation of positive work environment
- Deliver effective onboarding and training to new and existing employees and cross-trained staff members in other job roles to maximize coverage
Lead Clinical Research Coordinator (Infectious Disease and Immunization Health)
Henry Jackson Foundation for the Advancement of Military Medicine
2020.06 - 2021.12
- Responsible for complete conduct of EUA in-patient trials, specimen collection studies, and Immunization Health studies from start up to close out
- Creation and implementation of site specific study procedures, across multiple hospital departments
- Present research findings and needs to upper command
- Ensuring trial adherence to GCP and patient safety in DMID and IDCRP sponsored studies across therapeutic areas
- Ensure study team adherence to infection control procedures
- Oversight of daily study tasks
- Creation and implementation of study documents
- Complete study management, and management of study staff
- Oversight, completion, and instruction on IRB submissions
- Conduct study start up and close out activities per regulations and protocol
- Lab processing and large sample shipment in accordance with IATA
- EDC system maintenance and verification (EMMES and REDCap).
Clinical Project Manager (Immunology, Autoimmune Diseases, Asthma and Allergy)
Rho Inc.
2019.11 - 2020.05
- Responsible for feasibility, selection, set up, conduct and closure of clinical trial within allocated countries, in accordance with ICH-GCP, applicable legislation and Company Standard Operating Procedures through 6 month employment contract
- Responsible for operational management of clinical studies, ensuring compliance with timelines, milestones and budget
- Acted as main line of communication to relevant stakeholders and provided input to feasibility, study design, budget development and ensure progress reporting (resources, budget and timelines)
- Provide input on study related documents (e.g ICF, CRF, monitor plan, protocol, study Procedure Manual etc.), set-up and maintain study files.
- Achieved timely completion of all assigned clinical projects while remaining within budget constraints
- Developed strong partnerships with key stakeholders to facilitate smooth handovers during project transitions
- Oversaw contract negotiation and vendor selection for clinical projects, securing cost-effective solutions without compromising quality or timelines
- Improved clinical trial efficiency by streamlining project management processes and implementing best practices
- Facilitated strong relationships between study sites, sponsors, and internal teams through regular updates and effective communication strategies
Clinical Research Coordinator
Lineberger Comprehensive Cancer Center
2019.05 - 2019.10
- Conduct day to day study operations for OB/GYN oncology studies through 6 month employment contract
- Conduct study start up activities from study feasibility analysis for external sponsors to internal study implementation and cross functional staff training
- eCRF and EDC completion per protocol
- Communicate with sponsor and LCCC’s regulatory team to ensure timely submission of necessary documents
- Conduct study start up meetings
- Coordinate with other departments for studies and study activities
- Ensure patient safety and trial integrity through all activities.
Protocol Digitizer
Signal Path Inc
2018.02 - 2019.05
- Analyze and reconstruct Phase I-IV trial protocols in fields from oncology to neurology into an electronic format.
Prospective Trials Clinical Research Coordinator
Durham Veterans Affairs Medical Center/ Institute for Medical Research
2017.04 - 2017.08
- Lead CRC for multiple urology/oncology trials
- Responsible for daily operations of studies, and overall function of prospective studies division of IMR
- IRB oversight for all prospective trials
- Oversight of patient and study binders
- Ensure staff and PI compliance through training, training documentation, and delegation logs
- Partnership with National Institute of Health, National Cancer Institute, and multiple other hospitals, private practices, and universities
- Lead contact for sponsor’s
- IMR/VA representative (main point of contact) for site management calls and visits
- Development of budget proposals, timelines, scheduling and staffing needs
- Supervision of study personnel
- Supervise study personnel, residents, fellows, and students involved in clinical research across multiple centers
- Hire and train new study personnel as needed
- Time card approval, conduct performance reviews, respond to procedural questions.
Prospective Trials Coordinator
Research and Development Institute Inc
2016.06 - 2017.02
- Communicated with sponsors, PI’s, and other CRO’s to submit West and East coast sites.
- Promotion of the unique CRO/SMO hybrid model of RDI to sponsors, CRO’s, and medical practices
- Creation of site profiles that identified sites therapeutic area(s), essential staff, site capabilities, site layout, site equipment and staff certification
- Management of site staff CV’s, ML’s, and certifications
- Procurement of protocol specific site activation requirements
- Managed 30 prospective trials through feasibility to patient enrollment
- CIRB study submission
- Acted as a central point of contact for sponsor and site communication to ensure timely return and submission of any requests
- Remained in contact with all East and West Coast sites to provide updates, and ensure successful business relationship
Research Assistant
PulmonIX, LLC (externship)
2016.02 - 2016.06
- Internal critical care protocol translation to EDC systems.
Screening Coordinator and Research Assistant
High Point Clinical Trials Center (externship)
2012.09 - 2016.06
- Assisted in development of regulatory binders
- Extensive patient screening/scheduling through trial protocol review
- Source documentation and patient binder upkeep
- Patient relations
- Specimen Collection
- Medical history documentation
- Investigator interaction
- EDC data management and upload (EPIC, Oracle, InForm, RAVE, MediData, MERGE).
Education
Bachelor of Science - Psychology
High Point University
High Point, NC 2001.05 -
High School Diploma -
Middle Creek High School
Apex, NC 2001.05 -
Skills
Staff Supervision & International Team Leadership
Risk Identification and Mitigation
Feasibility through Close Out Trial Management
Portfolio Oversight
Stakeholder Relationship Management
Certification
CITI, 08/01/20
Education Awards
High Point University, High Point, NC, Bachelor of Science, Psychology, Research, Presidential Scholar, International Society of Psychology, 08/01/12, 05/01/16
Accomplishments
Large team supervision and management
International hiring, management, and supervision
Global span of control
Languages
Spanish
Limited Working
Timeline
Clinical Research Program Manager
Shriners Children's Hospital
2024.06 - Current
Clinical Operations Manager
ICON PLC
2021.12 - 2024.06
Lead Clinical Research Coordinator (Infectious Disease and Immunization Health)
Henry Jackson Foundation for the Advancement of Military Medicine
2020.06 - 2021.12
Clinical Project Manager (Immunology, Autoimmune Diseases, Asthma and Allergy)
Rho Inc.
2019.11 - 2020.05
Clinical Research Coordinator
Lineberger Comprehensive Cancer Center
2019.05 - 2019.10
Protocol Digitizer
Signal Path Inc
2018.02 - 2019.05
Prospective Trials Clinical Research Coordinator
Durham Veterans Affairs Medical Center/ Institute for Medical Research
2017.04 - 2017.08
Prospective Trials Coordinator
Research and Development Institute Inc
2016.06 - 2017.02
Research Assistant
PulmonIX, LLC (externship)
2016.02 - 2016.06
Screening Coordinator and Research Assistant
High Point Clinical Trials Center (externship)
2012.09 - 2016.06
Bachelor of Science - Psychology
High Point University
2001.05 -
High School Diploma -
Middle Creek High School
2001.05 -
CITI, 08/01/20
COVID-19 safety, 08/01/20
DHA privacy and GCP, 08/01/20
FDA OCT Drug Approval Process, 03/01/19
FDA Generic Drugs Overview, 03/01/19
FDA Abbreviated New Drug Review Process, 03/01/19
Medidate RAVE professional certification, 09/01/17
Oracle InForm GTM 5.0, 06/01/17
IATA Dangerous Goods, 04/01/21
CITI GCP, 08/01/20
ImageFirst, 04/01/16
CITI Social and Behavioral Responsible Conduct of Research, Information Privacy Security, 08/01/20
American Red Cross, 04/01/15
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