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 mentors junior level PMs.· Leads and participates in department initiatives.

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 data; responsible for making decisions and developing action plans to prevent or minimize study risk.· Creates and manages the clinical study timeline.· Develops, implements, and ensures adherence to the project management plan.· Oversees and reviews the deliverables produced by the team.· Manages all contractual and financial aspects of the project, including finalization of initial task order and subsequent amendments, monthly budget review including forecasting and assessment of work performed, and appropriate client invoicing.· Identifies, evaluates, selects, and manages external study vendors.· Prepares and presents information during face to face as well as remote meetings including weekly client meetings, annual investigator meetings, etc.· Regularly reviews study metrics and presents monthly to the department managers.· Reviews study entries in monthly timesheets submitted by HD staff.· Assesses and communicates resourcing needs with the department managers.· Escalates client and team issues to senior management as appropriate.· Appropriately delegates to team members while maintaining overall accountability for deliverables.· Provides overall guidance, motivation and mentoring to project team, including training plans as appropriate.· Creates and implements materials to ensure consistency across a client’s program of studies.· Serves as the primary back-up for the program director; led the program of studies while the program director was on maternity leave in 2018.· Assists the program director with planning the overall annual investigator meeting as well as other face to face meetings.

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 and other financial reviews.

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 and point of escalation for the clinical monitoring team regarding protocol, process, and site questions.· Reviewed monitoring visit reports and expense reports.· Tracked and oversaw monitoring activity projections to ensure appropriate visit forecasting.· Assisted PM with managing resource and utilization assessments, timeline adherence, quality assurance, and financial adherence as it pertains to clinical monitoring team activities.· Served as a secondary sponsor contact and overall back-up to the PM.· Provided overall clinical status updates to the PM and sponsors.· Escalated study issues to the PM and other managers of the clinical operations department when necessary.· Reviewed and approved invoices for clinical supplies and services.· Planned and facilitated internal clinical team meetings and external site teleconferences.· Created materials for and conducted training during investigator meetings, external teleconferences, and internal team sessions.· Supported the development of new CRAs including training during co-monitoring visits.· Prepared for, attended, and presented at client kickoff meetings.· Prepared for, attended, and presented at bid defense meetings.· Contributed to requests for proposal.· Contributed to company initiatives.· Served as a line manager for in-house CRAs.

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 product accountability, and reviewed the investigator site file during on-site monitoring visits.· Generated confirmation letters, monitoring visit trip reports, and follow up letters in a timely manner for each monitoring visit.· Generated and assisted in the closure of data queries.· Ensured appropriate documentation and follow-up for serious adverse events.· Identified, documented, and assisted in the resolution of issues or deficiencies relating to subject recruitment, study data quality, and overall study conduct at assigned study sites.· Provided updates to study team regarding assigned sites.· Attended project team meetings, departmental meetings and meetings with line manager.

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.• Develop employees to ensure optimal performance and retention of high quality employees.• Ensure clinical staff receive appropriate functional area training.

· 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 study-specific tracking tools (e.g. site start-up, supply, status trackers).· Assisted the CRAs with site visit preparation by identifying outstanding queries, CRFs, regulatory documents, and other items to focus on during the visit.· Assisted the PM with various study-related activities including circulation of study documents for review, assisted with the organization of face-to-face meetings, pre-populated documents, and reconciled investigator payments.· Worked closely with other team members to ensure timely resolution of project and/or clinical issues with direction from more senior clinical operations staff.· Performed limited monitoring responsibilities including co-monitoring sites, assisting with preparation of trip reports, in-house monitoring of data, query writing and communicating with/assisting sites.· Interviewed and assessed potential new-hire candidates for the In-House CRA and CTA positions.

· 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 for investigator meetings, training sessions, etc.· Internally audited employee training records to ensure compliance with company training requirements.· Conducted initial background research for new therapeutic areas and study designs.· Answered company phone line.· Performed additional administrative tasks as necessary in order to assist clinical study team with all aspects of study management.

• 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.• Contribute results to be used in a scientific article and obtain school credit by submitting a written report.

M.S., Clinical Research

B.S., Biochemistry, Psychology