Melody Sipp Email & Phone Number

Coldwater, Ms, Us

Cambridge, Massachusetts, Us

• Provide consultation in interpretation of regulations/guidelines, as they apply to GCP practice, awareness of regional regulatory requirement, and phase of study• In partnership with the Clinical Operations, Drug Safety & Pharmacovigilance, and Regulatory teams, contribute to the design and implementation of a risk-based clinical Quality Assurance management system• Identify QA and compliance related issues and implement solutions to ensure timelines are maintained• Assist with establishing metrics and reporting the state of GCP Quality and compliance of clinical trials to senior management• Support clinical quality oversight activities for multiple programs within Clinical Development• Assist with preparations for GCP/GPvP inspection-readiness for corporate Blueprint as well as CROs and investigator sites.• Assist with managing GCP/GPvP Inspections of Blueprint Medicines• Continue to develop as an SME for areas of responsibility during regulatory inspections and assist in managing inspection Ready-Room activities.• Ensure Clinical Development activities are compliant with cGCP, cGLP, FDA, ICH, EMA regulations and guidelines and industry standards• Review key safety, clinical and regulatory documents, such as DSUR, IB, IND and NDA• Provide QA oversight and auditing of TMFs• Assist and/or oversee consultant mediated audits; develop, recommend, and follow up on corrective actions• Plan and conduct complex audits / mock inspections in agreement with QA management• Assure through audits that non-clinical CROs, clinical CROs, clinical sites and supporting services are operating in compliance with the Company’s quality program, regulations/guidelines and SOPs and are acceptable for performing clinical studies and related services• Manage development of risk-based auditing schedules• Oversee the conduct of the GCP vendor procedures• Train and mentor staff on global GCP regulations and guidances

Montreal, Quebec, Ca

• Development of SOPs to support GCP compliance with consideration for the end users• Support the execution of Repare’s clinical development programs through administration and enforcement of the Quality Management System, providing GCP oversight including but not limited to deviations, corrective and preventative actions, investigations, and change controls, as applicable• Provide expertise in GCP compliance interpretation, consultation, training, and recommendations to assigned program teams• Complete routine TMF audits and work with the Repare clinical team and investigators, where necessary, to resolve any findings• Complete audits of GCP vendors• Complete clinical site audits• Develop and implement risk based GCP audit and compliance strategies and manage audits of sites, documents, databases, vendors or internal systems in compliance with GCP and Repare’s policies and procedures• Analyze, report, and present metrics for assigned programs to development teams and Repare QA management; recommend any required actions and monitor implementation• Assess impact of audit findings and other identified compliance risks to subject safety, data integrity, and business operations and escalate compliance risks to Repare QA management. Ensure audit reports and corrective actions are developed and completed within timelines mandated in internal procedures• Assist with investigations into significant quality issues, scientific misconduct and serious breach of GCP; facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness; ensure reporting of potential or confirmed violations to regulatory authorities• Provide GCP compliance support during inspections of investigator sites and Repare and assist with the development of appropriate and timely inspection responses and follow-up actions• Provide input and support for the development and improvement of QA processes

Blue Bell, Pa, Us

Watford, Hertfordshire, Gb

• Schedule, prepare, conducts and reports assigned audits of the Company’s projects and operational processes in accordance with approved procedures, schedules and formats.• Conduct independently or as lead auditor for internal, vendor, and PI External Quality audits. Write and distribute audit reports that describe audit findings.• Supervise the maintenance and continuous improvement of the overall quality system, including management review, CAPA management, internal quality audits, quality self-assessments, change control, document control, and standard operating procedures/work instructions • Write and issue audit reports in accordance with standard Company formats and timelines, ensuring clear communication of audit findings to the relevant project team members and/or functional area management.• Review responses to audit findings for appropriateness and completeness. Follow up as appropriate to obtain audit response.• Serve as the Quality resource for approval for critical processes (SOP development, deviations and various other tasks).• Support regulatory inspections.• Maintain site CAPA system for handling complaints and non-conformances• Write and maintain work instructions, SOPs, and customer specific processes and ensure team is trained on applications• Maintain document and change control with all regulated documents• Interpret policies, regulatory and/or governmental regulations, and agency guidelines to assure compliance.

Sydney, Nsw, Au

• Assists in coordination of feasibility process for proposed and assigned trials with activities that could include the following:- Identifies site list for blinded and un-blinded feasibilities as requested by CTM, PM or Clinical Operations teams- Manages distribution, collection, and tracking of signed CDAs when appropriate during feasibility process- Maintains database of site information from feasibility questionnaires (FQ Database), including site profiles for VECTOR investigator database as appropriate- Serves as primary point of contact during feasibility process to drive study feasibility to decision points according to established timelines- Provides ongoing reports and updates to the project team during feasibility process according to required timelines and project deliverables- Works with PM/CTM to develop final reports and recommendations of sites for Qualification Visits- Presents final results as required to PM team and/or Sponsor• Provides ongoing site management to ensure project completion within designated timelines- Works with projects managers to provide support to sites to facilitate accruals to studies- Maintains database of accruals for each study and site- Contacts study sites on a regular schedule to obtain feedback on study procedures and identification of site-specific problems- Addresses and/or triages questions from the sites- Maintains consistent communication with CRAs and PM regarding site updates and communication- Records site communication as per SOPs and/or project plans• eTMF as assigned by project- Uploads and maintains TMF files and folders in Vector’s file-sharing system by project, as assigned- Collects essential documents from sites on designated schedule- IRB Submissions- Prepares Central Study level IRB submission- Serves as primary contact for Central IRB as assigned- Prepares and submits site IRB submission packages- Manages IRB submissions as applicable

Herndon, Virginia, Us

Perform a variety of clinical research duties in support of clinical projects and operations involving process management, initiation, close out and reporting of Global Spine External Research Programs ERP.· Compiles and distributes various ERP reports to internal stakeholders, enters study documents into data repositories,· and manages print and hard copy materials· Consistently compiles and updates information including emails, reports, and other study documents into various documentation systems including hard files, controlled clinical server, and sitebuilder sites· Familiar with Good Clinical Practice GCP· Experience with clinical audits and clinical audit processes· Perform critical review of target records, identify any audit risks, recommend or take action to mitigate risks· Execute on publications searches and maintain results in publication tracker software· Execute on company stock withdrawl process and product shipment communications· Execute communications to internal and external stakeholders for information including IRBs, budgets, study progress updates· Perform special research projects at the request of the management team

Communicates with sites regarding trial start-up, conduct, and close-out activities.Collects and reviews regulatory documents from clinical sites .Initiates, maintains, and reconciles the mail file .Organizes and maintains tracking systems and tools to support the conduct of a clinical study from start-up to close-out.Maintains accurate tracking and reporting of study metrics.Coordinates communication of tracking information between Operations and vendors .Manages and tracks study specific payments.Manages and tracks clinical/non-clinical supplies.Generates and reviews management reports from internal tracking systems at requested intervals.Coordinates investigator meeting planning, including preparing meeting materials and on-site meeting implementation.Collaborates with head manager on the development of certain study specific plans and/or processes.Provides support to the appropriate teams.

Atlanta, Ga, Us

• The Regulatory Associate must create an increased alignment with the GSK Quality Management System and cGMP requirements for the manufacture of OTC Drugs and Medical Devices.•Update site Raw Material and Finished Product Specifications•Create, update BPR•Interact with internal/external Regulatory authorities during site inspections•Responsible for performing periodic audits for location accuracy of controlled documentation at the site•Create and update Technical Terms of Supplies•Analysis of data, generate Annual Product Reviews•Change Control Program•Fluent use of Microsoft Office Suite, Adobe Professional, the metric system of measurement, conversion and translation from American to and from metric system.•Strong organizational skills, interpersonal skills, and communication skills with all levels of the organization•Back up position to the Quality Technical Administrative•Back up position for generations of Quality Council Minutes and Data•Organization of the Deviation Program•Create, update SOPs that are applicable to Regulatory Compliance.•Perform gap analysis on documents that are applicable to Regulatory Compliance

Atlanta, Georgia, Us

•Follow the standard checkout process to ensure fast checkout•Follow the standard checkout process to ensure accuracy and to prevent shrink •Adhere to major & minor work rule policies regarding safety detailed in the “Code of Conduct”•Determine your short and long term goals, and work with the FES and •HRM to develop a SMART (Specific, Measurable, Attainable, Realistic, Timely) game plan

• Created a stable learning environment for educational success• Improved quality of learning• Prepared for end of course testing• Managed 130 students

Union, Nj, Us

• Maintained quality by adhering to LabCorp policies, procedures, and federal regulations• Demonstrated professionalism by ensuring ethics, integrity and confidentiality was established while managing patient records• Balanced and organized work-flow by prioritizing assigned tasks

• Maintained current documents on all purchase orders by sending out notices and updates data base with updated information• Followed all required day to day procedures as well as exceeded daily expectations by performing other duties as required and assigned• Input data and printed detailed reports on purchases, filed order receipts, and managed faxed information

Washington, Dc, Us

American Red Cross Saint Louis, MO 2004- 2010Collection Operation Support Associate• Coordinated Quality complaints and assessment of investigations associated with a both external customer complaints and internal downstream process complaints.• Create clinical project documents according to the protocol, including, but not limited to, source documentation forms and guidelines, monitoring Standard Operating Procedures (SOPs), monitoring visit templates and reports.• Perform investigative site file reconciliation: requests any new and updated site-related essential and non-essential documents and reviews them for content, consistency with other documents, and compliance with appropriate local, state, and national regulatory requirements, and Standard Operating Procedures (SOPs).• Ensure subject safety and adverse event reporting to sponsor and IRB.• Responds to requests from investigative sites in a timely fashion.• Ensured regulatory procedures were current and all employees were in compliance with educational recording system• Assist with the preparation of IRB applications, including protocol and informed consents and obtain • approval to conduct the study. • Maintain appropriate correspondence with the IRB, including adverse events, annual renewals and protocol amendments.Lead Laboratory Technologist• Interviewed, hired and trained staff for laboratory• Competencies and talent management developed as well as reported on staff performance evaluations• Managed quality and responsible for organizational work place compliance for 15-20 hired staff• Responsible for developing organizational policies while ensuring compliance • Performed maintenance on instruments as well as managed technical issuesLaboratory Technologist• Trained new hired staff• Performed annual assessments• Met and exceeded all deadlines• Stayed in compliance with all regulations and procedures for company success

Ms, Management With An Emphasis In Healthcare

Bs, Biology