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.

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.
• 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

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.
• 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).

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.
• 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.
• 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.

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.

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.

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

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.
• 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.
• Ensure subject safety and adverse event reporting to sponsor and IRB.
• Responds to requests from investigative sites in a timely fashion.

Ms, Management With An Emphasis In Healthcare

Bs, Biology