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Clinical Research Coordi, Regulatory Coordinator, Regulatory Affairs

Location:
New Castle, DE
Posted:
April 27, 2020

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Resume:

Dawn Ripley-Weeks, MSM

Cellphone: 302-***-****

adczgf@r.postjobfree.com

Qualifications:

●Extensive experience (25 years +) in pharmaceutical clinical and manufacturing industry-related research projects.

●Familiarized and conducted within the process of drug development to include clinical trials and regulatory approvals.

●Managed and trained up to 25 staff members and clinical personnel for cross-functional duties, specific assignments, and operations according to and in compliance with SOPs, FDA regulations and ICH/GCP guidelines to meet project goals.

●Considered excellent project management, interpersonal communications, and organizational skills while executing study start-up, site selections, enrollment, data collection, site maintenance, developed action plans addressing issues, and site closeouts.

●Accomplished double or triple recruitment goals to include International & Domestic Studies.

●Audited Quality Control Compliance for regulatory Documents while identifying and resolving issues regarding accuracy and completeness required by SOPs.

●Trained, organized, generated presentations along with training manuals, and implemented training sessions for management and clinical staff (Principal Investigators, Pharmacy, Nurses, and Therapists) to facilitate smooth operations of clinical research studies.

●Handled various therapeutic areas –project managed and monitored international and domestic studies within Oncology, Cardiology, Orthopedic, Rheumatology, Central Nervous System, Infectious Disease, Internal Medicine, Women’s Health, Vaccines, and Neuroscience within Phases I-IV.

●Technical Writer- created, edited, verified and implemented list of current products, process and validation status, volumes, sub-volumes, attachments, deviation documents, and Component & Finished Product. Scientific report auditing Batch Records, Chemistry Manufacturing & Controls (CMC), Laboratory Information Management System (LIMS), Child Resistant (CR), and Master Formula Records (R or C MFRs). Must have for products: validation report, bulk product stability, stability, development report, research report, post-valid monitoring research report. Also created, edited and updated Corrective and/or Preventive Actions (CAPA), Process Validations Plans (PVP), Process Performance Qualification (PPQ) Protocol Deviation Forms, templates and SOP’s for technical manufacturing documentation regarding Validation Master Plans (VMP) associated with the Consent Decree for site with GDP.

●Proven proficiency technical skills: Microsoft Word, Microsoft Excel, Access, Windows, Window XP, Vista, PowerPoint and SharePoint.

●Experienced in project management tools: Clinical Trial Management System (CTMS), International Management Package for the Administration of Clinical Trials (IMPACT), Clintrace, Clintrial, eRoom, Clinical Study File (CSF), Electronic Document Management System (EDMS), Interactive Voice Response System (IVRS), Compliance Wire, etc.

●Familiarized with Food and Drug Administration (FDA) regulations, Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), Health Insurance Portability and Accountability Act (HIPAA), Institutional Review Board (IRB)/ Independent Ethics Committee (IEC), Investigational New Drug (IND), New Drug Application (NDA), Serious Adverse Events (SAE), International Conference on Harmonization (ICH), and Standard Operating Procedures (SOP).

Diversified Positions:

Kelly Services – Apr 2018/Present

●Administrative duties for the Delaware Brandywine School District and various companies.

Home Health Care - May 2016/Present

●Assist healthcare patients with medications, meals, personal hygiene and errands.

McNeil Consumer Healthcare (Johnson & Johnson)

Technical Writer - Nov 2012 /Dec 2013

●Participated in Consent Decree overhaul for Technical Operations Procedures.

●Created and edited very complex technical and manufacturing documentation.

●Developed, recommended and implemented corrective and/or preventive actions (CAPA) for technical and manufacturing documentation processes and changes to meet regulatory quality requirements with GMP.

●Identified Installation Qualification (IQ), Performance Qualification (PQ), and Operational Qualification (OQ).

●Conducted team meeting (agenda & minutes).

●Covered various projects leading to quality improvements and production systems.

●Created SOP’s site VMP (validation master plan) and attachments for Process Validations.

●Created protocol deviation forms and documents.

●Audited protocols and document reviews with GDP.

Pennsylvania Oncology/Hematology Associates / University of Pennsylvania

Regulatory Affairs Coordinator - Aug 2011 / July 2012

●Managed oncology research studies by preparing and submitting documentation packets to include regulatory documents (protocols, investigator brochures, amendments) for local Institutional Review Board regarding new protocols, annual reviews, modifications and terminations of studies while meeting deadlines.

●Prepared FDA 1572, financial disclosure forms, revised consent forms to reflect IRB’s requirements, and revised Investigator Brochures (IB’s).

●Reported Adverse Events (AE’s), Serious Adverse Events (SAE’s), IND safety reports, and action letters to sponsor companies and/or FDA within regulatory timelines.

●Participated in and supported all site auditing and monitoring visits while maintaining protocol regulatory documents in compliance with local and US Oncology Standard Operating Procedures. Communicated, reviewed and documented Regulatory Memoranda with physicians and other clinical staff as appropriate.

●Updated and maintained regulatory files by filing and auditing existing regulatory documentation (CV’s medical licenses, lab certifications, lab normal ranges and requested information) for the IRB and sponsors.

●Assisted in the development and implementation of policies and procedures for regulatory documentation functions.

Wyeth Laboratories Inc. / inVentiv, Collegeville, PA

QA Analyst – Regulatory - July 2006 / May 2011

●Project management of United States and International Trial Master Files for multiple therapeutic studies.

●Created and organized templates for Trial Master Files (TMF) in database for multiple Therapeutic studies.

●Managed 5 Document Coordinators pertaining to clinical study file SOP compliance, to complete & meet departmental and project goals, and multiple tasks timelines for efficiency.

●Quality Assurance for Regulatory Documents (1572’s, Financial Disclosures, Curriculum Vitae, IRB & IEC Documents, Clinical Correspondence, Lab Documents and Certifications, Drug Shipping Documents, Signed Investigator Approvals, Site Monitoring Visits, and Serious Adverse Events.

●Involved member of the Inspection Readiness Team: NDA & FDA/IEC Approvals- Prevnar (Vaccines) 7 & 13 Valent, BeneFIX (Hemophilia/Oncology) Coagulation Factor, and Bapineuzumab (Neuroscience) Alzheimer’s.

●Identified and resolved issues regarding accuracy and completeness required by SOP’s by adding, deleting, changing and or updating documents not compliant with FDA guidelines within the EDMS system.

●Followed guidelines under FDA/IRB in the United States, (IEC) International Ethic Committees in Europe, (MHLW) Ministries of Health, Labor and Welfare in Japan, and various federal guidelines in Asia.

●Coordinated multiple priorities and resources effectively to meet demanding deadlines and timelines.

●Encouraged quality training for the Document Specialist Coordinators using the training modules and monitor performances given. Communicated and became a liaison for US and International country sites with clinical regional monitors, research coordinators, project managers, and directors.

●Assisted with the Study File Managers (SFM) and Clinical Trial Managers (CTM) to maintain regulatory documentation was managed according to Good Clinical Practice, Regulatory Requirements, and Standard Operating Procedures.

Education:

● Wilmington University, New Castle, DE

MS – May - 2011

Major: Healthcare Administration – GPA 3.3 – 4.0

●Wesley College, New Castle, DE

B.A. May - 2009

Major: Business Administration – GPA 2.8 – 4.0

Dean’s List – multiple classes

●Delaware Technical Community College, Wilmington, DE No degree - 2007

Major: Allied Health Studies – GPA 3.3 – 4.0

Dean’s List – multiple semesters

References - Furnished upon request.



Contact this candidate