AUGUSTINA EKHAIYEME

*/**/****

Mooresville NC ***15/ Cell: 704-***-****

ad3sy2@r.postjobfree.com

Office: 704-***-****

Summary

Experienced in the management of: Clinical; and Supply Chain and Logistics (Logistics).

Has over 8 years of work experience in clinical research coordination across phases I – IV clinical trials and clinical project management, with 5 years of management experience including a high level position.

Adept at navigating clinical research guidelines, CFR Part 11, Part 81, GDP, and FDA regulations.

Work Experience

American Carolina Clinical Research (April 2021 – Jan 2024)

Site Manager/Chief Operating Officer

Lead and manage the research team, overseeing daily clinical trial activities.

Conduct performance reviews, training, task delegation, and scheduling of direct reports.

Represent the company professionally to pharmaceutical companies, partners, CROs, and physicians.

Handle IRB submission and tracking, ensuring 100% compliance with federal regulations.

Provide support and supervision for regulatory affairs, ensuring compliance with sponsor protocols.

Contracts/Budgets Negotiation.

Coordinate personnel/site staff payroll activities and assess staffing needs.

Facilitate communication between administrative staff, research coordinators, and site staff.

Develop and maintain operational reports, contribute to the development of new studies and budgets.

Manage and document communications with external stakeholders.

Assist with writing, revising, and formatting various documents.

Serve as a central resource to support and coordinate site operations.

Ensure compliance with research protocols, standards, laws, and regulations.

Manage study budgets/contracts and strive to meet assigned goals.

Demonstrate excellent interpersonal and communication skills.

Care-Access Research (July 2019 - March 2021)

Clinical Project Manager

Coordinated and managed clinical trials from start-up through closeout activities.

Directed technical, financial, and operational aspects to ensure successful trial completion.

Identified and evaluated fundamental project requirements with functional area leads.

Traveled to sites/vendors to assess project progress and compliance.

Ensured staff training on study protocols and adherence to professional standards.

Initiated improvements to enhance project efficiency and quality.

Managed project plans, site/vendor management, and budgets.

Conducted investigator and study meetings, authored and reviewed study protocols.

Participated in clinical operations initiatives and data analysis.

Drove study startup, patient recruitment, clinical monitoring, and study closeout.

Carolina Clinical Research, Charlotte NC (June 2016 - June 2019)

Clinical Research Coordinator

Scheduled subjects for research study visits using computer scheduling software.

Managed IRB-approved advertising campaigns for recruitment.

Created and submitted regulatory documents for new clinical trials.

Coordinated clinical trials, adhering to Good Clinical Practice principles.

Collected initial medical background and coordinated study-related procedures.

Maintained accountability for study supplies and investigational products.

Demonstrated superior communication and organizational skills.

Developed materials supporting the conduct of clinical studies.

Professional Development

Founder, Africans in Clinical Research

Member, Association of Clinical Research Professionals (ACRP)

Member, Black Women in Clinical Research (BWICR)

Member, Minority in Clinical Research

Certified Clinical Research Coordinator (CCRC) – In View

Education

Imo State University, Owerri - Bachelors in Medical Laboratory Science (2016)

Imo State University, Owerri, Nigeria - MSc in Medical Laboratory Science (2018)

Core Skills & Competencies

Documentation Review.

Experience in CTMS, EDC, eTMF, eCRF, tracking and project management systems.

Strong knowledge of project management principles and methodologies.

Proficiency in JIRA, including the ability to create and manage projects.

Ability to work independently and make decisions.

Experience with clinical research global regulations and guidelines.

Clinical Trial start-up to Close-out.

Ability to prioritize, meet deadlines, and manage multiple projects simultaneously.

Delivers high-quality, timely work product with significant autonomy.

Ability to build trust with site personnel and communicate effectively.

Detail-oriented with excellent problem-solving skills

Proficient in Microsoft Office Suite

Positive attitude, adaptability, reliability, open-mindedness, and willingness to learn from others

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