Valencia D Moore

CONTRACTOR

• Supported Lead Study Manager and Clinical Operations team with tasks to ensure the smooth implementation of the study protocol at 12 participating country sites, to foster speedy patient enrollment and retention.
• Established strong relationships with key stakeholders, facilitating open lines of communication and fostering a collaborative working environment.
• Meeting transcription and archival.
• e-TMF document tracking/filing.

Study Start Up:

• Managed kick-off calls, participated in SIV calls; communicating study status updates to internal teams throughout start up process.
• Collaboratively participated in the selection of appropriate clinical sites by conducting thorough feasibility assessments based on predefined criteria.
• Mentored more than 5 Sr CTAs/CTM I
• Acted as the clinical point person managing study execution for more than 12 trials.
• Facilitated clear communication between study teams, sponsors, investigators to maintain alignment on project goals and expectations. Managed cross-functional teams to ensure clinical program timelines and deliverables achieved.
• Managing Phase I-IV trials of various diseases. Ensuring trial adherence to ICH/GCP/local regulations.
• Prepared detailed progress reports for sponsors and stakeholders, keeping them appraised of key developments in ongoing trials.
• Worked with PI and sponsors to facilitate daily trial activities and comply with research protocols.
• Complied with research protocols by providing ongoing quality control audits.
• Enhanced customer satisfaction rates through detailed analysis of customer feedback data and subsequent improvements in service offerings.

EMR Analyst:

• Responsible for protocol/amendment build in the electronic medical record (EMR), which entails extracting data directly from the protocol/study documents and building into the EMR platform to aide sites with performing necessary study visit procedures for patients.

• Project management for 20-30 treatment and non-treatment studies, in various statuses and phases; identifying and resolving issues daily.
• Performed essential support for clinical research throughout all stages of a project, tracking and prioritizing trial metrics such as patient enrollment, study training, deliverables, study deviation, and site participation data, including data backlog; ensuring accuracy and completion of all processes for site close out.
• Collaboratively participated in the selection of appropriate clinical sites by conducting thorough feasibility assessments based on predefined criteria.
• Evaluated vendor performance regularly to ensure high-quality services were provided throughout the duration of the clinical trial.
• Prepared detailed progress reports monthly for sponsors and clinical operations stakeholders, keeping them appraised of key developments in ongoing trials.
• Enhanced patient safety by meticulously monitoring clinical trial activities and promptly addressing any issues.
• Ensured compliance with regulatory guidelines by thoroughly reviewing protocols, informed consent forms, and other essential documents.
• Fostered strong relationships with investigative sites, leading to increased collaboration and improved study outcomes.

(Contract employee Aug 2016-April 2017)

• Project management for non-treatment studies (registries and studies closed to enrollment)
• Created, modified, maintained, and distributed study forms and tools to research sites; including but not limited to protocol specific flow sheets, clinical trial information sheets, and training documentation.
• Monitored trial progress for compliance with regulatory and budgetary requirements; responsible for management of related documentation.
• Collaborated with internal departments/teams to ensure completion of all trial aspects (financial/legal/etc) prior to study closure.
• Provided administrative support to Program lead for assigned disease committees.
• Management of Sunshine Reporting to sponsor partners.

• Assisted clinical research investigators and research staff across the institution with maintaining federal/institutional regulatory compliance and GCP throughout the conduct of clinical trials.
• Analyzed 10 or more research applications received by the Office of Protocol Research each month for regulatory compliance and recommended appropriate revisions.
• Ensured proper administrative handling of the research application and timely submission to the appropriate agency.
• Provided specialized technical assistance on applications to MD Anderson Cancer Center (MDACC) faculty and staff.
• Prepared/maintained documentation on the administrative flow of MDACC research applications. Cleaned/obtained/maintained data.
• Created complex reports for use in reviewing specific application information and general trends. Collected metrics and participated in department quality assurance.
• Developed recommendations on operations and processes.
• Acted as a coach and team leader to new hires.

• As a Regulatory Coordinator in the Department of Breast Medical Oncology, assisted clinical research investigators and research staff with maintaining federal/institutional regulatory compliance and GCP throughout the conduct of clinical trials.
• Handled all initial/follow up regulatory document submissions (1572s, CVs/MLs, FDQs, DORs, etc.)
• Resolved Sponsor/monitor queries. Organized regulatory binders. Managed annual protocol renewals. Maintained department prioritization lists. Completed SAE reports. Coordinated Research Staff and Faculty/Research meetings.