Project Manager Quality Assurance

NAME Christy D. Beaudoin-Parker

DEPARTMENT Late Phase Research

EDUCATION

**** ******** ** *******, ****** Promotion

East Carolina University,

Greenville, NC, USA

PROFESSIONAL EXPERIENCE

10/ 2011 to Present Lead CRA

OPTUMInsight

Richmond, VA, USA

• Responsible and accountable to manage and provide leadership with all clinical monitoring activities in accordance with established timelines, budgets and contractual terms, Monitoring Plan (MP) and Key Performance Indicators (KPI). Identify and escalate out of scope activities.

• Develop and write Clinical Monitoring Plan, provide training on MP and oversee CRA compliance with MP.

• Assist SMC project team members in identifying and selecting investigators and make recommendations for selection of sites.

• Oversee and lead the conduct of on-site qualification, initiation, interim monitoring and study closeout visits for Late Phase Interventional and Observational studies in accordance with federal regulations, Good Clinical Practice (GCPs), ICH Guidelines, Standard Operating Procedures (SOPs), Monitoring Plan (MP) and business processes, which is accomplished by detailed review of subject records, essential documents, investigational product disposition and accountability, site personnel and procedures, as applicable for each study.

• Generate, review, approve and distribute high quality monitoring reports and site follow-up letters. Ensure delivery timelines are met.

• Develop study specific training materials, logs, tools and forms. Train CRA team as necessary.

• Conduct study planning, managing and troubleshooting and ensure appropriate escalation of issues.

• Manage enrollment issues, resolution of data queries and site performance issues.

• Complete in-house clinical data review.

• Collect and validate study data, metrics and Trial Master File (TMF).

• Track supply inventory, site enrollment, data queries, SAEs/UADEs, project training and resolutions.

• Manage the preparation of clinical sites for client and internal audits and regulatory agent inspections.

• Ensure compliance with regulatory requirements, GCPs, company and client policies and procedures.

• Recognize the need to seek assistance or inform senior management of specific issues.

• Monitor and implement quality assurance activities within the SMC.

• Mentor and train junior Clinical Research Associates by sharing best practices and knowledge. Acts as an excellent resource. Provides constructive feedback and adapts coaching and mentoring approach to meet the style or needs of the individuals.

• Maintain compliance with Clinical Trial Management Systems (CTMS) and administrative functions (e.g., expense reports, time entry, corporate / department training).

• Overnight travel 20%-30%.

• Develop clinical reports, SOP revisions and document quality control.

• Represent Clinical Monitoring and present at client and team meetings (e.g, bid defense, kick-off meetings, Investigator meeting, and project teleconferences).

• Perform Quality Assessment Visits or CRA Transition visits with CRAs as needed.

• Perform or oversee additional aspects of phase IV/registry/prospective research projects from inception to completion within the SMC which include but are not limited to: site management activities, recruitment of study investigators, regulatory document and site contract collection, Institutional Review Board (IRB)/Ethic Committees (EC) submissions, and preparation of study manuals, operational plans, project- specific templates/correspondences and review monitoring reports

• Participate in the recruitment/selection of on-site or in-house CRA’s, as required

• Oversee study budget relating to all monitoring tasks.

9/ 2011 to 9/2011 Project Manager

Bostwick Laboratories

Richmond, VA, USA

• Managed clinical trial research studies in an effective and quality manner and assure that study objectives are met

• Effectively developed, implemented and managed comprehensive study plans in accordance with contractual timelines and client specifications.

• Conferred with site monitors and coordinators to explain protocol and to elicit adherence to protocol guidelines; identify potential problems and/or inconsistencies and take action as appropriate

• Prepared a variety of reports, documents and correspondence for participating clinical trial companies and for internal purposes to assist in the ongoing monitoring and evaluation of the clinical trial’s progress

• Assisted study sponsor and/or other members of the research team in the development of study manuals; contribute to the ongoing analysis and modification of study documentation as appropriate

• Contributed to the development of new procedural manuals and SOP’s necessary for the processing and reporting of trial specimens; contribute to the ongoing analysis and modification of procedures as appropriate

• Inspected and reviewed all outgoing correspondence, reports, etc. to ensure completeness and accuracy of data and info provided

• Assisted in the distribution of study related materials to sites and sponsors as required

• Provided exceptional customer services skills when dealing with clients and client representatives

• Administered, supported, enforced and ensured compliance with ICH/GCP, GLP, HIPAA, and confidentiality procedures and laws as it relates to the study subject, trial materials, expenditures, outcomes and clients for the entire Clinical Trials Department

• Assumed other duties as assigned by management

• Responsible for all equipment in assigned areas of work.

8/2010 to 9/2011 Manager of Clinical Operations

PRA International

Charlottesville, VA, USA

• Assessed clinical operations employee resources and employee resource projections to ensure that project teams meet client expectations and PRA contractual obligations.

• Determined level and type of employee resources to meet corporate/client/project objectives

• Scheduled and reviewed project tasks, provided leadership in the delivery of services to clients

• Managed 15-25 CTMs/ CRAs/ In-House CRAs

• Ensured staff fulfills their responsibilities in accordance with PRA’s policies, procedures, SOPs, ICH-GCPs, and country specific regulatory requirements

• Recommended and implemented clinical operations performance and productivity improvements to optimize utilization of billable staff

• Participated in PRA’s quality efforts for continuous improvement by assuring quality metrics are in line with company, client and clinical operations objectives

• Managed operational budget within respective budget guidelines.

• Provided input to central proposals for project bids to ensure all projects

• Provided guidance/insight on aspects of clinical operations, as well as contingency planning, to accommodate project or therapeutic-specific nuances while identifying potential impacts of the same to budget

• Participated in client presentations and/or bid defense meetings, as required

• Interfaced with clinical staff across PRA business units, providing input and feedback to promote quality deliverables

• Assisted in the development of PRA employees to ensure optimal performance and retention of high quality employees

2/ 2008 to 6/2010 Regional Manager

i3 Research

Cary, NC, USA

• Performance management related duties, including:

Assessed, tracked and managed employee activities to ensure delivery of quality clinical trial management services, achieving the stated goal of client and i3 Research.

• Monitored Key Performance Indicators to ensure employees meet objectives

• Tracked and managed CRA visit metrics to ensure CRAs were allocated appropriately to projects in order to achieve metrics on a monthly, quarterly and annual basis.

• Provided guidance on adherence to protocol specified visit schedules to manage/ meet/ exceed MBOs.

• Identified and addressed performance issues and training needs. Developed action plan/ implementation when additional training is required.

• Tracked delivery of services by contractors and review of contractor invoices to ensure appropriate billing and those services provided are consistent with contractual obligations/ agreement.

• Provided guidance and support to regional monitoring personnel.

• Served as a resource and mentor for monitoring questions\issues\local regulatory requirements.

• Provided guidance regarding company policies and procedures.

• Maintain home office

• Performed routine performance assessment/ training visits to evaluate on-site performance, including:

• Performed Accompanied Monitoring visits annually (minimum) for each employee; performed more frequently as needed.

• Coordinated training and implementation of company’s quality control initiatives.

• Maintained employee files as appropriate, including training records and corporate CVs.

• Attended meetings and teleconferences as appropriate.

• Reviewed, approved and tracked non-project related expenses for direct reports.

• Managed HR activities.

• Maintained knowledge of local HR issues/policies.

• Assessed workload of regional monitors using Ellipsis and Siebel Clinical.

• Participated in staffing and resource allocation.

• Provided support in the recruitment of regional monitors including the review of potential candidates, screening interviews, and face-to-face interviews followed by hiring recommendations.

• Participated in company-required training programs and quality assurance activities and conduct training needs analysis of each employee [including on-site evaluation] to develop and manage individualized training and development plans.

• Participated in quality assurance audits conducted internally or with the sponsor as required.

• Reviewed reports and evaluate communication skills as needed for areas of improvement, including: ensure monitor demonstrates knowledge of SOP, GCP/ICH Guidelines and other applicable regulatory requirements.

• Maintained communication with Project Manager on regular basis.

• Coordinated orientation and training plan with project management team. Inform the project manager of work performance issues with regional monitor.

• Collaborated with project manager in the follow up on performance issues.

• Provided Support to Business Development including: participate in client meetings and assist in the development of client proposals.

• Represented the regional management function at client audits.

• Managed personal career development and administrative tasks including: participate in company-sponsored training programs as required to ensure that skills are learned, maintained, and focused accordingly.

• Performed necessary administrative functions and additional tasks as requested.

• Provided management oversight in support/ development Lead CRAs:

o Supported/ training/ development of the Lead CRAs in the Clinical Monitoring department through F2F training, web ex sessions, monthly LCRA meetings, review of all new templates, SOPs and logs that impact the LCRA role, development of core LCRA competencies, etc…

o Clinical Quality Project Global Coordinator Role: oversight to allow the Lead CRAs on global programs to have an escalation pathway for field monitoring issues specifically on a project and will add assurances that meeting timelines and deliverables as well as addressing quality of the deliverables overall are being met. Bridging the gap between NA and ROW for all clinical monitoring activities and customer deliverables.

7/2006 to 2/2008 Senior Clinical Research Associate/ Lead CRA

i3 Research

Cary, NC USA

• Performed routine site visits, including pre-study, initiation, interim, and closeout visits. Visits to include monitoring of proper informed consent procedures, compliance with protocol, GCP/ICH Guidelines and other applicable regulatory requirements and assurance of good site performance. This is accomplished by detailed review of subject records, essential documents, investigational product disposition and accountability, site personnel and procedures

• Managed assigned sites by regular contacts to ensure site compliance, adequate enrollment, and understanding of study requirements. Reported to i3 Research project team, client, and site personnel any findings noted at monitoring visits. This is accomplished by completion of monitoring reports and follow-up letters within the project-specific timelines. Significant issues noted must be reported to appropriate personnel immediately.

• Maintained eClinical or alternative project tracking system of subject and site information.

• Served as back up for Regional Manager, Regional Clinical Monitoring Group when required.

• Provided training for colleagues on clinical, regulatory, administrative, and company procedures and processes.

• Participated in feasibility studies.

• Assisted with company’s quality control initiative.

• Presented study materials at Investigator/study launch meetings when required.

• Supported project management team with assessment of workload and site assignments within the project team.

• Assisted project management team with review of monitoring reports and study documents when required.

• Participated in the interview process of potential candidates when required.

• Participated in company-required training programs.

• Performed necessary administrative functions (e.g., tracking of expense reports, time and attendance).

• Maintained home office (e.g., procurement of office supplies, submission of documents).

• Performed other duties as assigned.

8/2005 to 7/2006 Clinical Lead

Otsuka Pharmaceutical

Rockville, MD, USA

• Oversaw CRO clinical trial management of clinical trials.

• On site CRA observation of CRO CRAs to ensure quality monitoring and assess overall site management.

• Assisted in continuing education/ training of in house clinical teams.

9/ 2004 to 8/ 2005 Senior Clinical Research Associate/ Lead CRA

i3 Research/ Ingenix

Cary, NC USA

• Performed routine site visits, including pre-study, initiation, interim, and closeout visits. Visits to include monitoring of proper informed consent procedures, compliance with protocol, GCP/ICH Guidelines and other applicable regulatory requirements and assurance of good site performance. This is accomplished by detailed review of subject records, essential documents, investigational product disposition and accountability, site personnel and procedures

• Managed assigned sites by regular contacts to ensure site compliance, adequate enrollment, and understanding of study requirements. Reported to i3 Research project team, client, and site personnel any findings noted at monitoring visits. This is accomplished by completion of monitoring reports and follow-up letters within the project-specific timelines. Significant issues noted must be reported to appropriate personnel immediately.

• Maintained eClinical or alternative project tracking system of subject and site information.

• Served as back up for Regional Manager, Regional Clinical Monitoring Group when required.

• Provided training for colleagues on clinical, regulatory, administrative, and company procedures and processes.

• Participated in feasibility studies.

• Assisted with company’s quality control initiative.

• Presented study materials at Investigator/study launch meetings when required.

• Supported project management team with assessment of workload and site assignments within the project team.

• Assisted project management team with review of monitoring reports and study documents when required.

• Participated in the interview process of potential candidates when required.

• Participated in company-required training programs.

• Performed necessary administrative functions (e.g., tracking of expense reports, time and attendance).

• Maintained home office (e.g., procurement of office supplies, submission of documents).

• Performed other duties as assigned.

4/ 2002 to 9/ 2004 Clinical Research Associate II

i3 Research/ Ingenix

Cary, NC, USA

• Reviewed and tracked study documents (e.g., case report forms, source documents, adverse events) to ensure completeness and accuracy.

• Communicated and interacted with site staff and sponsor to convey basic project information or answer routine questions.

• Reviewed, clarified, and obtained data changes via query with site personnel and assist data management in reviewing data lists and writing queries.

• Compiled and verified clinical data for status reports.

• Visited sites to monitor adherence to study protocols or FDA requirements relative to clinical research as needed, or coordinated with regional monitors to achieve the same; also prepared and submitted completed monitoring reports based on any site visit.

• Assisted in maintaining the project files and database information pertaining to the study.

• Ordered and tracked drugs and supplies as needed.

12/ 2000 to 4/2002 Clinical Research Associate

Parexel International

Durham, NC, USA

• Collected and reviewed regulatory documents.

• Reviewed CRFs and source documents.

• Performed source verification.

• Performed drug accountability.

• Conducted qualification, initiation, interim monitoring and termination visits.

• Developed tracking tools, study forms and manuals.

• Created the database for regulatory document tracking.

• Developed the study newsletter for multiple protocols.

• Developed and maintained the Questions and Answer Log.

• Developed the Central Files submission form and worked as a liaison between Central Files and the clinical team.

• Resolved queries and worked with data management and the clinical team on resolution techniques.

• Co-monitored /Trained team members on the protocol(s).

• Working knowledge of GCPs, ICH guidelines and SOPs.

2/ 2000 to 11/2000 In House Clinical Research Associate- Late Phase

PPD Incorporated

Morrisville, NC, USA

• Conducted qualification, initiation and site management visits

• Monitored CRFs via fax/in-house review upon completion

• Collected and reviewed regulatory documents

• Wrote monitoring and telephone reports

PROFESSIONAL MEMBERSHIPS

1998 CCRA Certification/ Member- ACRP

SUMMARY OF THERAPEUTIC EXPERIENCE

Cardiovascular, Infectious Disease, Women’s Health, CNS, Ophthalmology, Transplant and Endocrine.

SUMMARY OF PHASE EXPERIENCE

Phase I Number of studies: 5

Phase II Number of studies: 15

Phase III Number of studies: 10

Phase IV Number of studies: 7

AUTHENTICATION

The information contained in this document is accurate and complete to the best of my knowledge.

Employee/Contractor ID Number 000130186

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Signature Date

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