AUGUSTINA EKHAIYEME, BMLS, MMLS
Mooresville,NC
Summary
Experienced professional with 8+ years in clinical research coordination and project management. Strong background in Clinical and Supply Chain management, sales, and logistics. Skilled in navigating clinical research guidelines, CFR Part 11 and Part 81, GDP, and FDA regulations. Authorized to work in the US for any employer.
Overview
8
8
years of professional experience
1
1
Certification
Work History
Site Manager/Chief Operating Officer
American Carolina Clinical Research
Charlotte, NC
04.2021 - 09.2024
- Led and managed research team, overseeing daily clinical trial tasks.
- Conducted performance reviews and training sessions.
- Established professional relationships with pharmaceutical companies, partners, CROs, and principal investigators.
- Managed IRB submission and tracking.
- Supported and supervised regulatory affairs ensuring compliance with sponsor protocols.
- Facilitated negotiations for optimal financial agreements.
- Coordinated payroll activities for personnel and site staff.
- Coordinate interactions among administrative, research, and site teams.
- Ensured adherence to all research regulations and laws.
- Prepared budgets and monitored expenses to stay within allocated limits.
- Established policies, procedures and guidelines for the operation of the site.
- Mentored new employees on safety protocols, processes and procedures.
- Provided training opportunities for existing staff in order to enhance their skillset.
- Resolved conflicts between staff members in a timely manner.
- Implemented systems for tracking employee attendance, performance reviews and payroll processing.
- Collaborated with vendors for procurement of materials needed for projects.
- Negotiated contracts with suppliers for services such as catering or transportation needs.
- Organized events at the site such as conferences or workshops.
- Reviewed project plans regularly to ensure deadlines are met on time.
- Directed site activities to drive smooth operations and achieve quality assurance metrics.
- Interviewed and hired qualified candidates to fill open staff positions.
- Complied with operational standards and OSHA regulations.
- Maintained payroll data, attendance records and delivered materials to job site on time and in good condition.
- Retained records of supplies and tools used and tasks performed for each project.
- Prepared detailed progress reports for stakeholders, highlighting milestones and addressing potential issues.
- Conducted risk assessments, implementing mitigation strategies to minimize project delays.
- Created and managed budgets for travel, training, and team-building activities.
- Maintained records of inventory, assets, personnel and other relevant data.
- Analyzed reports to identify areas for improvement in performance or cost savings.
Clinical Project Manager
Care-Access Research
Charlotte, NC
07.2019 - 03.2021
- Oversaw clinical trials, ensuring completion from start to finish.
- Coordinated various aspects including technical direction, financial oversight, and operations for trials.
- Collaborated with functional leads to assess key project requirements.
- Traveled to various site locations for project assessments.
- Maintained adherence to professional standards through training.
- Enhanced quality of projects by initiating improvements.
- Controlled allocation and oversight of budgets.
- Led investigator and study meetings.
- Contributed to improving project outcomes through participation.
- Facilitated study initiation and patient enrollment processes.
- Developed and implemented project plans to ensure timely completion of clinical trials.
- Organized and led cross-functional teams to manage the development, execution, and reporting of clinical studies.
- Assessed study progress and identified potential risks or delays in order to develop strategies for mitigation.
- Conducted periodic meetings with stakeholders to review project status and address any issues that may arise.
- Collaborated with internal departments such as regulatory affairs, pharmacovigilance, data management, medical writing, biostatistics. to ensure successful completion of projects.
- Prepared budgets for each trial including resource allocation across all sites involved in the study.
- Provided guidance on GCP and ICH guidelines along with applicable regulations throughout the lifecycle of clinical trials.
- Reviewed study documents prior to submission to regulatory bodies for approval purposes.
- Interacted with external vendors such as central laboratories, contract research organizations, imaging centers to coordinate services related to a given trial.
- Maintained communication channels between sponsors and investigators by providing updates on study progress or changes in protocol requirements.
- Negotiated contracts with vendors regarding cost estimates and service levels required for successful execution of studies.
- Ensured compliance with SOPs while managing multiple projects simultaneously within budget constraints.
- Compiled data from various sources into meaningful reports; analyzed results obtained from clinical studies; provided recommendations based on findings reported therein.
- Identified opportunities for process improvement through analysis of operational processes associated with clinical trials conducted at global sites.
Clinical Research Coordinator
Carolina Research Center
Shelby, NC
06.2016 - 06.2019
- Compiled trial related documents into a master file as required by sponsor or regulatory agency.
- Assisted in preparing periodic reports summarizing progress of clinical studies.
- Developed and maintained accurate and timely study databases.
- Assisted in the preparation of Institutional Review Board submissions for clinical trials.
- Performed patient assessments, collected and analyzed data, and prepared reports.
- Monitored patient safety during clinical trials according to established guidelines.
- Provided guidance on Good Clinical Practice regulations and other applicable regulatory standards.
- Coordinated investigator meetings, conference calls, and site initiation visits as needed.
- Collaborated with internal departments such as Regulatory Affairs and Data Management to ensure that all studies were conducted in accordance with ICH-GCP guidelines.
- Communicated effectively with investigators, study staff, sponsors, vendors, IRB personnel, and other stakeholders throughout the life cycle of the trial.
- Reviewed medical records for accuracy of source documentation prior to database lock.
- Reviewed CRFs for completeness and accuracy before database entry.
- Maintained accurate up-to-date tracking logs for all aspects of clinical research activities including but not limited to adverse events, serious adverse events, concomitant medications, lab results .
- Assessed records of each patient, reviewed databases and checked referrals to locate potential research study participants.
- Collected, processed and delivered specimens from trial participants.
- Adhered to standards in areas involving data collection, research protocols, and regulatory reporting.
- Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.
- Monitored subject enrollment and tracked dropout details.
- Took vital signs and collected medical histories as part of study protocols.
- Conducted screening interviews to determine eligibility of possible subjects.
- Educated participants on studies and anticipated outcomes.
- Placed orders for IPs to be used in studies.
Education
Doctor of Business Administration - DBA In Healthcare Management And Global Leadership
California Intercontinental University
Irvine, CA02-2027
MSc - Medical Laboratory Science
Imo State University
Owerri, Nigeria09.2018
Bachelors - Medical Laboratory Science
Imo State University
Owerri, Nigeria09.2016
Skills
- Clinical Trial Lifecycle Management
- Meticulous Attention to Detail
- Effective Problem Resolution
- Guideline Adherence Expertise
- Experienced with Microsoft Office Suite
- Building Trust with Personnel
- Document Evaluation
- Project Management Frameworks
- JIRA Workflow Optimization
- Optimistic Mindset
- Versatile Team Collaboration
- Consistent Dependability
- Adaptable Thinking
- Eager to Learn
- Clinical Research Management
- Supply Chain Oversight
- Remote Patient Care
- Operational Leadership
- Inside Sales Strategies
- Growth-Focused Business Development
- Clinical Data Analysis
- SharePoint Collaboration Tools
- Strong Time Management
- Clear Communication Skills
- Contract Negotiation Expertise
- Strategic Category Management
- Leadership Development
- Quality Assurance
- Laboratory Techniques Proficiency
- Skilled in Python Programming
- Applicant Tracking Systems
- Java Programming
- Oracle Database Management
- Expense Analysis
- Corporate Financial Management
- Digital Marketing
- Clinical Monitoring Expertise
- Technical Proficiency
- Knowledge of FDA Regulations
- Clinical Research Standards Knowledge
- Site-Based Network Collaboration
- Strong Presentation Skills
- Collaboration with Trial Center Staff
- Analytical Decision Making
- Prioritization and Scheduling Expertise
- Proficient in Data Collection Methodologies
- Data Validation
- Proofreading Expertise
- Qualitative Analysis Approaches
- Skilled in Providing Technical Support
- Understanding of Certification Protocols
- Accurate Detail Orientation
Certification
- Certification in Infection Prevention & Control, 02/01/24, 02/28/25
- Bloodborne Pathogens Certification (Infectious Disease Control Best practices/precautions), 02/01/24, 02/28/25
- HIPAA, 02/01/24, 02/28/25
- ICH/GCP, 12/01/21, 12/31/24
- IATA Certification, 03/01/22, 03/31/24
- Certified Safety Professional, OSHA 30
- Driver's License
- Certified Project Manager, OSHA 10
- BCBA
Personal Information
Work Permit: Authorized to work in the US for any employer
Languages
English
Native/ Bilingual
Accomplishments
- Histopathology Lab
- Hematology/Blood-Bank
- Medical Microbiology
- Chemical Pathology Lab
Affiliations
Best Student in clinical posting- 2014 (ImO State University Teaching Hospital)
References
References available upon request.
Timeline
Site Manager/Chief Operating Officer
American Carolina Clinical Research
04.2021 - 09.2024
Clinical Project Manager
Care-Access Research
07.2019 - 03.2021
Clinical Research Coordinator
Carolina Research Center
06.2016 - 06.2019
Doctor of Business Administration - DBA In Healthcare Management And Global Leadership
California Intercontinental University
MSc - Medical Laboratory Science
Imo State University
Bachelors - Medical Laboratory Science
Imo State University
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