SUMMARY:

• Resourceful leader with 10 years of clinical research experience, including 6 years of Contract Research Organization (CRO) experience serving on global pharmaceutical studies. Experienced with overseeing global clinical research studies and IRB trial designs for CROs and investigator sites. Adept at developing, executing, and managing clinical studies (Phases I - IV) within the therapeutic areas of Central Nervous System (CNS), Pain, and Oncology. Proficient in ensuring that all study initiatives align with research goals. Led and managed program development from inception to completion in hospital, healthcare facilities. Focused on tracking project results, milestone attainment, direct Confidential t outreach strategies, and investigator site staff members on related protocol requirements. Valued professional recognized for exemplary customer service, exceptional communication skills, ability to work well both independently and in a team environment.
• Project Management Clinical Trial Operations Regulatory Submissions Site Selection
• Confidential t Recruitment Vendor Performance Management Budget Management Strategic Study Planning
• Study Metric Analysis Database Management Interface with Principal Investigators and pharmaceutical sponsors

TECHNICAL SKILLS:

Highly skilled with the following software: Proficient with Adobe Acrobat, Microsoft Professional, and Microsoft Office products, including: Word, PowerPoint, SharePoint, Excel, Visio, and Outlook.

Highly skilled with the following databases: Proficient with FDA Electronic Submission Gateway and PeopleSoft (Oracle products), including: PS Financials Reporting, PS Billing Unit Review, Compass (Contracts and Budget), and Trial360.Also skilled performing duties in CTMS (Clinical Trials Management System), Medidata Rave, InFORMant, InnTrax, InForm, IMPACT, Almac IVRS & IXRS, ClinPhone, eCOI (electronic Conflict of Interest), eCTS (electronic Contract Tracking System), CTSU (Clinical Trials Support Unit), ISIS (International Safety Information System), SIR (Safety-to-Investigator Reporting), CTEP (Cancer Therapy Evaluation Program), OnCore, and Veeva (eTMF).

PROFESSIONAL EXPERIENCE:

Confidential, Cary, NC

Clinical Project Manager (Remote)

Responsibilities:

• Responsible for the implementation of Confidential t outreach strategies and tactics.
• Identified and presented project related issues and facilitated resolutions both in and across function.
• Involved with the development of bid defense and created other team presentations.
• Managed relationships with investigator sites to ensure timely transfer of regulatory documents, recruitment materials, IRB submissions, and follow up on referral dispositions.
• Ensured schedules were maintained and liaised with project stakeholders to provide quality assurance for content at each stage of project development.

Confidential, Atlanta, GA

Clinical Trials Regulatory Affairs Manager

Responsibilities:

• Managed, organized, and executed regulatory submissions prior to established deadlines.
• Maintained internal regulatory document databases and interfaced with external databases.
• Provided Quality Assurance reviews of the clinical development of regulatory documents.
• Participated in the scientific design and strategic implementation of Investigator Initiated study plans.

Confidential, Marietta, GA

Clinical Project Manager

Responsibilities:

• Recommended database management procedures on a per study basis.
• Oversaw the execution of data cleaning activities and timelines as detailed in Data Management Plans (DMPs).
• Accelerated investigator site selection process by providing recommendations based on feasibility metrics.
• Responsible for the development of new hires and provided performance feedback.
• Ensured schedules were maintained and liaised with project stakeholders to provide quality assurance for content at each stage of project development.

Confidential

Clinical Project Support Specialist

Responsibilities:

• Generated, maintained, and updated various project reports (including study metrics, enrollment and expense reports, etc.).
• Monitored enrolling sites performance for subject accession.
• Organized eTMFs and ensured the quality of required submissions (Safety Reports, resource management, etc.).
• Received “Work worth Doing” s in recognition of my attention to detail and organization.

Confidential, Henderson, NV

Clinical Research Associate

Responsibilities:

• Queried data inconsistencies and revised CRFs in compliance with Standard Operating Procedures (SOPs).
• Conducted Pre-Study Site Qualification, Site Initiation, Interim, and Close-Out monitoring visits.
• Reviewed trial documents (including: 1572s, Delegation of Authority Logs, regulatory submissions, Informed Consent Forms, Confidential t study materials, AE, and SAE reports, etc.).
• Performed site management duties, including Confidential t recruitment strategies and medical query resolution.
• Also provided protocol, SOP, and AE Reporting to site Principal Investigators and site staff members.
• Managed trip reports, site correspondence letters, query resolutions, and expense reports.

Confidential

Sr. Clinical Trial Associate

Responsibilities:

• Responsible for collecting data from clinical trials created for pharmaceuticals, biologic, and devices studies.
• Communicated with Clinical Trial Managers weekly to ensure the timely receipt of regulatory documents by clinical sites.
• Organized client databases according to specific data requests.
• Oversaw study sites adherence to data cleaning and data query response schedules.
• Maintained records for established systems that supported regulatory activities and requirements.

Confidential, Upper Saddle River, NJ

Science Editorial Project Manager

Responsibilities:

• Created project work plans and adjusted timelines to meet shifting priorities and demands.
• Edited and revised literary content for accuracy, consistency, and completeness.
• Managed vendors, assigned developmental projects and processed payment upon completion of assignments.
• Effectively communicated, prepared, and managed vendor manuscript submissions, and assured that forecast deadlines were achieved.
• Prepared and presented program presentation materials for both internal and national program meetings.
• Recognized for self-motivation, maintaining the forecast project budget, and proactively solving budget problems.

Confidential, East Orange, NJ

Special Science Teacher

Responsibilities:

• Catered to students with learning disabilities and delays, as well as emotionally disturbed children.
• Developed curriculum and adapted lesson plans to meet students’ unique learning styles and abilities; while preparing IEPs (Individualized Programs) for each student.

Confidential, Newark, NJ

Biomedical Research Apprentice

Responsibilities:

• Oversaw animal environmental care throughout the study cycle; while maintaining experimental data and technique notebooks.
• Experience with in vitro and ex vivo assays, collection of tissue samples, and animal surgery in small male rodent animal models.