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CURRICULUM VITAE

Lauren WatsonEmail: [email protected]: 267-475-3739

Career SummaryYears in Industry 10 YearsTherapeutic Area(s) Experience

Cardiovascular; Chronic Heart Failure; Ventricular Tachycardia; Hematology;Iron Deficiency Anemia; Infectious Disease; Vaccines (Pediatric and Adult); Mental Disorders; Attention Deficit Disorder; Attention Hyperactivity Deficit Disorder; Depression; Musculoskeletal; Osteoarthritis; Neurology; Indication; Urology; Chronic Kidney Disease; Respiratory Infections; Pulmonary Diseases; Oncology

Clinical Research Development Phase(s)

Phases I – IV, EAPs, Registries

Geographies U.S. and Global Trial ExperienceLanguages EnglishProfessional Summary: Clinical research professional with a strong work ethic and the ability to function

well under pressure working within Regulatory and Quality Assurance, and Clinical Trial Management. Ensure timeliness, orderliness and safekeeping of all study documentation throughout their lifecycle in clinical trials. Extensive experience in eTMF/CTMS UAT implementation and training, SOP writing, metric reporting, Vendor Management, Scope of Work (SOW) management, and study start-up through study closure with conducting Clinical Internal/External Audits.

CURRENT POSITION: United BioSource Corporation Blue Bell, PASenior Clinical Trial Specialist Sept. 2015 to PresentSenior Regulatory Document Specialist Jan. 2014 to Sept 2015

Manage Regulatory and Institutional Review Board (IRB) Activities: Responsible for performing investigative site recruitment/feasibility and

site project training Prepare, distribute, collect, evaluate, and approve regulatory documents

required for regulatory compliance and IRB submission. Submit regulatory documents to Central IRBs and manage site

submissions to Local IRBs; confirm IRB approval is received and documented.

Conduct regulatory packet submissions to clients for site approval and drug release.

Create and review project planning documents including but not limited to Essential Document Review Plan (EDRP), Site Management Plan, and Project Plan.

Track milestones, generate study metrics, and provide written and verbal updates to internal and external customers including Scope of Work (SOW) management and Vendor Management.

Confirm sites have notified IRB of closure and final subject status in compliance with regulations.

Confirm sites have returned or destroyed study drug and other study supplies as required.

Train sites on their continued contractual, regulatory, and legal obligations.

Conduct Site Management Activities:

mailto:[email protected]

CURRENT POSITION:(CONT.)

Evaluate sites to determine interest, adequate subject population, facilities, staff and qualifications to conduct a study.

Execute confidentiality agreement, contract and budget negotiation with sites.

Provide site training and access to required systems, including vendor systems.

Provide site training and guidance in reference to protocol compliance. Provide site training and guidance in reference to regulatory requirements

and ensure compliance. Manage site relationships to ensure positive interactions through routine

site contact. Evaluate site performance and compliance with required FDA

regulations, ICH/GCP, and local laws. Confirm sites are compliant with subject rights and privacy requirements. Ensure sites meet subject safety reporting regulations: subject safety

information is disseminated appropriately by evaluating consistency, quality and timeliness of serious adverse events reported by the site and submission to the IRB.

Manage site inventory of study drug, laboratory supplies, and any other study materials to ensure sites have sufficient inventory to conduct study activities without delay.

Escalate potential misconduct, fraud or noncompliance by sites to Project and Functional Management and Quality Assurance.

Instruct sites on study or protocol requirements and determine subject qualification based on subject eligibility parameters.

Track study activities, milestones, document receipt, and payment status in CTMS.

Participate in internal/external project team meetings. Assist with other duties as assigned.

Essential Document Management and Audit Readiness: Create Trial Master Files (TMF) and maintain essential documents in

compliance with FDA regulations, ICH/GCP, and local laws. Manage ongoing collection and quality review of updated essential

documents for submission to the TMF. Preserve document security and integrity. Ensure Regulatory Authority and Client audit readiness of TMF. Prepare, package, and archive TMF at study closure.

Perform Remote Monitoring Activities: Verify accurate and timely electronic data entry of study subject

information. Review electronic data and ensure protocol deviations are reported to

IRB as appropriate. Collaborate with sites to achieve query resolution of electronic data. Manage sites in meeting subject enrollment targets to meet contractual

obligations. Conduct remote monitoring visits and complete requisite visit reports.

Facilitate Payment Distribution to Investigative Sites: Contribute to project plans outlining payment strategy. Evaluate data to identify milestones ensuring sites are paid according to

the contract.

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CURRENT POSITION:(CONT.)

Process and distribute investigative site payments.

Additional Job Duties: Demonstrates ability to successfully lead, mentor, and train CTSs. Provides feedback on CTS performance regarding department goals and

objectives. Develops solutions to complex issues, analyze current policies and

procedures, and recommend changes as needed. Generate and review project specific metrics as needed. Demonstrates ability to successfully lead and mentor CTS staff, take on

high level tasks as delegated by Project Manager/Functional Manager, escalate and mitigate risk as appropriate, and demonstrates complete understanding of UBC systems and work environment

PROFESSIONALEXPERIENCE:

ICON plc North Wales, PASenior Clinical Program Assistant Sept. 2013 - Jan. 2014

Assisted in maintaining, updating and disseminating progress reports, tracking tools, program timelines and project plans with project specific information collected from the functional lines of the global clinical trials in the programProviding administrative program assistance ensuring all project deliverables are met according to program timelines, budget, operational procedures and quality standards.

Assisted in planning, coordinating, and tracking program activities and facilitates team communication under the supervision of the Sr. Director of Global Project Management ensuring compliance with SOPs, Scope of Work (SOW) management, Vendor Management, policies, working guidelines, good clinical practices, and applicable regulatory requirements

Ensured that the Trial Master File is accurate, complete and audit ready Assisted in quality control audits of clinical study documentation Assisted with the coordination and tracking of project-related information,

status reports and communication across the project teams and departments Provided administrative support for efficient project team meetings, both

internal and external, including scheduling, participation, preparation and distribution of meeting minutes, and maintenance of action item logs

Managed the administrative start-up, inspection readiness, and close out activities.

Conducted internal audits and assist with external audits related to the TMF processes and activities.

Traveled domestically and internationally to assist with internal and external Quality Assurance/ Quality Control audits by regulatory bodies ( FDA and MHRA,)

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PROFESSIONALEXPERIENCE:(CONT.)

ICON plc North Wales, PATrial Master File Study Owner Aug. 2011 – Sept. 2013

Responsible for the design and set up of complete and accurate Trial Master Files documentation ensuring compliance, quality, consistency and timely filing across all clinical trials.

Responsible to ensure that the clinical trial documentation is consistent with the Trial Master File specifications, applicable SOPs, ICH/GCP guidelines and other regulatory agencies requirements.

Responsible that the e-Trial Master Files are submission/inspection ready. Develops and assists with the implementation of the e-Trial Master File

specifications. Regulatory packet requirements, blinded vs. unblended documentation and

location. Ensure Trial Master File project specifications are in alignment with program strategy and study time line milestones.

Provided and conducted eTMF system set-up and training to all study team members.

Ensured that all team members are compliant with Training according to SOPs and TMF processes.

Provided consistent setup and maintenance of TMF requirements and processes and programs.

Ensured that documentation flow for TMF documents meet the required timelines and intervene with action plans and follow up as appropriate.


Traveled domestically and internationally to assist with internal and external Quality Assurance/ Quality Control audits by regulatory bodies ( FDA and MHRA,)

Developed of corrective action plans related to TMF findings. Review data quality outputs and audit outputs to identify trends per study and across programs.

Provided Lessons Learned information. Comply with metrics established in Merlin for performance TMF reviews Responsible to ensure that TMF documentation is completed prior to study close/submission.

Attended all study team meetings as required. Assess clinical trial documentation being created internally and externally with for alignment with the Master Trial Master File Document List and applicable SOP’s.

Assisted in with changes in scope and preparation of change orders. Clinical Trial Master List Documentation and SOP Review including voting and decision making.

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PROFESSIONALEXPERIENCE:(CONT.)

ICON plc North Wales, PAStudy Authorization Associate I/ Study Start-Up Associate I Aug. 2011 – Dec. 2011

Responsible for the preparation and approval of country related submission packages in accordance with ICH, GCP and all applicable regulations, laws, and other guidelines and ethical standards.

Reviewed and approved site level critical documents for Investigational Product release in accordance with regulatory/sponsor requirements.

Attend at Kick-Off, Investigator or study team meetings. Perform feasibility, site identification, site contract negotiation, and other study start up activities.

Prepared, reviewed, and submitted submissions to ethics and regulatory and other relevant authorities in order to obtain all necessary authorizations/approvals pertaining to the clinical trial conduct. Including ethics/regulatory/other relevant authority approvals for clinical trials, ethics/regulatory/other relevant authority approvals for trial amendments, ethics/regulatory/other relevant authority study notifications, authorizations for import/export of investigational products, clinical supplies, and biological samples, approvals from the national authorities for data protection.

Developed and finalized Country Specific SIS/ICFs. Prepare and finalize Country Specific xml files. Review and translate Drug Labels.

Performed independent quality review of submission packages. Collected and maintained current Regulatory/Competent Authority and Ethics

Committee submission information, and similar information for other related organizations for assigned countries.

Responsible for the translation and coordination of translations for documents required for submission.

Performed timely and accurate data entry of regulatory documents, submission status and maintenance of Country/Investigator information in the appropriate CTMS.

Responsible for the timely follow-up for queries made by CA/EC. Responsible for the collection of critical documents required for IP release. Assembled and distributed study materials to clinical and project teams,

materials to study sites and investigator meetings and vendors. Conducted internal audits and assist with external audits related to the TMF

processes and activities. Traveled domestically and internationally to assist with internal and external

Quality Assurance/ Quality Control audits by regulatory bodies ( FDA and MHRA,)

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PROFESSIONAL EXPERIENCE:(CONT.)

Phlexglobal Malvern, PATeam Lead May 2011 – June 2011

Managed a team responsible for several aspects of workflow. Super-user within the eTMF team to be experienced and practiced in all

elements of the eTMF workflow. Responsibility for authorizing and tracking leave, mid-year and annual

performance development plans, training and personal development plans. Worked with colleagues on a proactive, effective and cost efficient approach

to resource allocation to meet the needs of the business. Coordinated new staff induction plans & Phlexglobal training. Worked with Management team of eTMF Operations & Technical

Development team to review processes and create changes to existing processes.

Provided daily, weekly and/or monthly reports to Senior Team Leader. Analysis of project data and various matrices.

Trouble shooting, resolving equipment problems/failures and rectifying processing issues immediately.

Assisted in writing and review of relevant Phlexglobal Quality Processes and SOPs.

Processed client documentation. Assisted in the design and implementation of all relevant systems.

Conducted onsite Rater Certification Meetings, including program and conduct onsite knowledge checks via Audience Response Systems, and record onsite investigators’ meetings for archive purposes.

Responsible for the following tasks supporting project service offerings: User Administration, Study Module creation, Online and Onsite meeting planning, moderation, conduct, report generation, and special projects, as determined by the Associate Director, Rater Training.

Maintained the role of lead coordinator for: Data Monitoring Application – data entry and maintenance of patient visit sheet into the application, Rater/Site Specialist – Lead site/rater support specialist: primary point of contact for raters/site personnel regarding rater training.

The lead site support specialist helps to manage metrics and rater status. Primary Monitor’s Contact – lead support specialist as primary point of contact regarding rater training.

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ePharmaSolutions Conshohocken, PAProject Lead, Global Training Rater Services Nov. 2010 – Dec. 2010

Supported various day-to-day operational and administrative activities, including the planning and implementation of all project services.

Assisted in the design and implementation of all relevant systems including, but not limited to, the Rater Training Workspace, Rater Selector Survey Report, Rater Training Report, Rater Certification Report, Applied Skills tracking, etc.

Supported rater and site follow-up for all project services. Conducted onsite Rater Certification Meetings, including program and

conduct onsite knowledge checks via Audience Response Systems, and record onsite investigators’ meetings for archive purposes.

Responsible for the following tasks supporting project service offerings: User Administration, Study Module creation, online meeting planning and moderation, Onsite meeting planning and conduct, report generation, Special projects, as determined by the Associate Director, Rater Training, Interacted with client, study team, and third-party personnel, Maintained the role of lead coordinator for: Data Monitoring Application – data entry and maintenance of patient visit sheet into the data monitoring, application, Rater/Site Specialist for a rater training project – Lead site/rater support specialist: primary point of contact for raters/site personnel regarding rater training.

The lead site support specialist helps to manage metrics and rater status. Primary Monitor’s Contact – lead support specialist as primary point of contact regarding rater training. Assisted in the setup, conduct and follow-up of client meetings.

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ReSearch Pharmaceutical Services Ft. Washington, PARegulatory Affairs Assistant June 2010 – Nov. 2010

Set up and maintained regulatory study document files (Trial Master Files (Paper and Electronic) which includes Case Report Forms) using either RPS or client specifications.

Ensured timeliness, orderliness and safekeeping of documents and files throughout their lifecycle within RPS.

Entered and checked status of regulatory documents in clinical trial management systems. Interact with RPS Clinical Operations staff (e.g. Project Managers, Project Assistants, CRAs, and Quality Assurance), investigative site personnel, and clients in order to obtain proper clinical site documentation.

Supported preparations and follow-up activities related to internal and client QA audits.


Traveled domestically to assist with external audits by regulatory agency (FDA)

Supported general Regulatory Document Room operations, e.g., provided documents (copies or originals) upon request, reviewed files that were received, tracked files that were borrowed, and shipped files to clients or third-party archives, according to applicable RPS SOPs.

Maintained current awareness of all projects that were kept in the record room and their status.

Assisted the Manager, Regulatory Affairs with the review of essential regulatory documents including FDA Form 1572, site-specific or study template informed consent forms, for completeness and accuracy.

Provided assistance as needed to Manager, Regulatory Affairs

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Luitpold Pharmaceuticals Norristown, PAClinical Project Coordinator Dec. 2008 – May 2010

Assisted in Site Recruitment and Start-up processes by acting as a primary point of contact with investigative sites.

Prepared, collected, tracked, filed and maintained Regulatory Documents throughout each study.

Prepared site files for approval by Regulatory Management. Acted as a liaison between investigative sites and Clinical Research Associates in CRA absence.

Management of CRA travel, tasks, and responsibilities throughout all studies. Ordered, tracked, and maintained study drug supplies and distribution.

Performed In house remote monitoring activities Generated and maintained study-specific tracking spreadsheets (e.g., patient

enrollment, regulatory documents, site visits, Vendor records, etc.). Managed Paper and EDMS Trial Master File’s for Phase I through IV trials.

Trial Master File Reconciliation. Prepared, collected, maintained and completed IRB Submissions, Approvals

and Informed Consents. Assisted in preparation, collection, maintaining drug

safety/Pharmacovigilance submissions and distributions to Investigative sites. Managed and coordinated shipment of study supplies and documents to

vendors, investigative sites, and IRB. Completed Audits of Investigator files in preparation for study closure. Participated in team meetings and provided status updates. Performed other tasks as requested by Clinical Project Managers.

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PharmaNet (now InVentiv Health Clinical Research) Blue Bell, PAClinical Trials Assistant Mar. 2007 – Nov. 2008

Provided clerical and administrative support to project teams. Provided clerical and administrative back-up support to Administrative

Assistant as needed. Set-up and maintained project files. Set-up and maintained investigator files. Faxed, photocopied, filed and distributed study-related documents. Managed Paper and EDMS Trial Master File’s for Phase I through IV trials.

Trial Master File Reconciliation. Contacted study personnel at sites regarding administrative issues. Ordered office supplies as needed by project team. Generated and maintained study-specific tracking spreadsheets (e.g., patient

enrollment, regulatory documents, site visits, and investigator payments). Regulatory Document Preparation of: 1572, Medical Licenses and CV’s,

Financial Disclosures, Personal Data Consent Forms, Protocol Acceptance Forms, IRB Submission, Approvals and Informed Consents, Ship/mail supplies and documents to clients, investigator sites, and IRBs, Assist in assembling materials and binders for Investigators’ Meetings, Prepare regulatory binders (Study File Notebooks) for study sites, Created and Maintain Investigator contracts and payment documentation.

Reserved various meeting halls and conference rooms and participate in team meetings.

SCI-Chester and SCI-Graterford Prisons Chester, PACertified Medical Assistant Mar. 2006 – Mar. 2007

Duties include reviewing sick call sheets, running sick call clinic daily for inmates' care

Oversee Blood Lab and Infirmary (prn), phlebotomy, EKGs, PEs, vision screening, BPs, administer foot wraps/ soaks, cream ointments for psoriasis, poison ivy, eczema, fungal infections, etc., hot/cold packs, wart-offs, Albuterol treatments, ear irrigations, finger sticks (diabetes testing), administer oral medication under RNs supervision.

Medical records (MARS-Medical Administration Records) filing of all x-rays/lab/psych/TB results etc., faxing, order supplies, count, take and stock inventory as needed, and perform exit medical clearances for CCC and Parolees. Also travels to SCI-Graterford Prison working as a Phlebotomist to run Blood Lab.

CERTIFICATIONS: National Certified Medical Assistant, 2006National Center for Competency Testing

CONTINUINGEDUCATION:

Western Governors University - OnlineSalt Lake City, UTBusiness Management DegreeAnticipated Graduation Date :December 2017

EDUCATION: STAR Technical Institute Upper Darby, PA

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Diploma/Certification, Medical/Clinical Assistant January 2006

Samuel S. Fels High School Philadelphia, PAHigh School Diploma June 2004

COMPUTER SKILLS: Microsoft Office; Citrix; eTMF’ (Various Systems): EDMS; Sharepoint; Documentum; Merlin

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