Abbey Townsend Email & Phone Number

Durham, North Carolina

In additional to the responsibilities of the PM I position:· Drafts, reviews and contributes to protocols, clinical study reports, manuscripts and other publications.· Assists the business development department, as needed, in development of proposals and case studies as well as attendance at bid defenses and other face to face meetings.· Trains and.

Durham, NC

· Leads cross-departmental teams to ensure assigned clinical studies are delivered on time and within budget while meeting quality standards.· Serves as primary project contact for the client, third-party vendors, and any other project stakeholders.· Responsible for analyzing, interpreting, summarizing and effectively presenting clinical study performance.

Durham, NC

In addition to the responsibilities of the CTL I position:· Assisted with managing study budget.· Independently managed study vendors.· Interviewed and assessed potential new-hire candidates for the CTL position.· Served as a combination PM/CTL for two smaller studies with minimal PM oversight. Performed all PM tasks with the exception of monthly invoice.

Durham, NC

· Initiated and oversaw the clinical activities of the study start-up process (e.g. tracking and reporting progress of site activities, supplies, etc.)· Created, reviewed, modified, and maintained study specific templates, plans, and processes (e.g. clinical monitoring plan, site visit templates, study procedures manual, etc.)· Acted as a primary resource.

Durham, NC

In addition to the responsibilities of the CRA II position:· Prepared and presented information during investigator meetings.· Participated in department initiatives.· Assessed and signed off CRA trainees.· Interviewed and assessed potential new-hire candidates for the CRA position.

In addition to the responsibilities of the CRA I position:· Assisted with site feasibility and investigator selection.· Assisted in the creation of study-specific documents.· Reviewed trip reports for more junior CRAs.· Conducted internal training for more junior CRAs.

· Served as primary point of contact for study-related questions and issues from study sites.· Provided study-specific training to the study site staff.· Performed pre-study site selection (qualification) visits, site initiation visits, interim monitoring visits, and close-out visits.· Conducted source document verification, performed investigational.

• Assist the CTA Line Manager with the following items:
• Manage clinical affairs employees.
• Provide leadership in the delivery of services to clients.
• Jointly with Project Managers, ensure staff fulfills their responsibilities in accordance with company policies, procedures, SOPs, ICH-GCPs, and specific regulatory requirements.
• Recommend and implement clinical productivity improvements to optimize utilization of billable staff.
• Interface with clinical staff providing input and feedback to promote quality deliverables.

· Prepared and distributed regulatory start-up packages to clinical study sites.· Maintained the Trial Master File by requesting, collecting, reviewing, tracking, and filing all essential documents throughout a clinical study.· Reviewed informed consent forms to ensure all required elements were present.· Created and maintained department and.

· Obtained, distributed, and tracked non-investigational product study supplies.· Shipped investigational product to sites.· Created and maintained study website (e.g. study announcements, enrollment metrics, study documents, etc.).· Organized internal meetings.· Drafted meeting agendas and meeting minutes.· Assisted with the development of presentations.

• Plant and harvest DNA from wild species peanut plants.
• Perform sequencing of peanut DNA from 294 mutant lines.
• Perform extraction of DNA from wild species peanut plants.
• Prepare master mixes of primers and agarose gels.
• Perform quantification of the extracted DNA.
• Other responsibilities include the preparation of experiment materials, organization of lab materials, demonstration of proper OSHA requirements, data management, time management, and greenhouse maintenance.

M.S., Clinical Research

B.S., Biochemistry, Psychology