Deb N. Email and Phone Number

Perform risk assessment to internal and external applications, systems, supporting tools. • Lead risk register, risk treatment and risk reporting process. • Support assessment program and perform internal and external security assessments making recommendations on next step actions. • Perform risk assessments to identify and document risks faced by the organization. • Oversee and perform Standardized information Gathering (SIG) risk assessments. • Research new trends in risk… Show more Perform risk assessment to internal and external applications, systems, supporting tools. • Lead risk register, risk treatment and risk reporting process. • Support assessment program and perform internal and external security assessments making recommendations on next step actions. • Perform risk assessments to identify and document risks faced by the organization. • Oversee and perform Standardized information Gathering (SIG) risk assessments. • Research new trends in risk management, standards, technologies, and framework revisions • Contribute to third party security and compliance tasking to facilitate continuous improvement and ensure alignment with governance, compliance, security and risk with a strong focus on control frameworks (e.g., HITRUST, HIPPA, SOC2, ISO, etc.), • Review third party reports (e.g., SOC2, etc.) and other compliance certifications and regulations and monitor, report and escalate on identified control deficiencies. • Track and monitor remediation and risk management activities. Show less

• Collected and reviewed essential documents from Investigational sites.• Supported TMF set-up, maintenance, ongoing quality review, and final reconciliation of study documents. • Participated/ lead in study specific tasks such as Investigator identification, recruitment, collection of Investigator regulatory documents and site activation.• Contributed to the development of the Monitoring Plan and assists with ensuring appropriate quality and timely monitoring of clinical… Show more • Collected and reviewed essential documents from Investigational sites.• Supported TMF set-up, maintenance, ongoing quality review, and final reconciliation of study documents. • Participated/ lead in study specific tasks such as Investigator identification, recruitment, collection of Investigator regulatory documents and site activation.• Contributed to the development of the Monitoring Plan and assists with ensuring appropriate quality and timely monitoring of clinical sites.• Performed document tracking and signature/approval follow-up, where applicable, including Confidential Disclosure Agreements (CDAs), contracts, proposals, invoices, and other study documentation• Assisted in the management of CAPA after site audits and follow up with CRO’s regarding audit reports.• Worked with internal and external team members (i.e., Clinical Supplies, Toxicology, PK, Regulatory Affairs, Clinical Data Management and CRO/Vendors) to deliver high quality trial execution. Show less

• Initiated follow-up activities to investigative sites as needed, to retrieve missing information, according to SAE reporting requirements, regulatory guidelines, and department SOPs.• Classified serious adverse events according to regulatory reporting criteria and performed WHO coding, MedDRA coding, as per SOPs and guidelines.• Prepared narratives, according to approved Working Practice or Protocol.• Maintained a thorough understanding and strict adherence to GCP guidelines and… Show more • Initiated follow-up activities to investigative sites as needed, to retrieve missing information, according to SAE reporting requirements, regulatory guidelines, and department SOPs.• Classified serious adverse events according to regulatory reporting criteria and performed WHO coding, MedDRA coding, as per SOPs and guidelines.• Prepared narratives, according to approved Working Practice or Protocol.• Maintained a thorough understanding and strict adherence to GCP guidelines and regulatory reporting regulations.• Documented/Reported AE’s, SAE’s, and ADR’s according to care plans/protocol.• Assisted in the management of CAPA after site audits. Show less

FDA regulations including 21CFR Parts 11, 50, 54, 56 and theCommon Rule ICH E6 (R2) GCP (ALCOA-C) HIPPA regulations Regulatory affairs (FDA Form 1572, Training logs, RegulatoryBinders, Protocol Investigator’s Brochure, DOA, Pre-Trial EssentialDocuments etc. Creating Source data Protocols and SOP’s compliance Assisting in recruitment and retention of research subjects Phases in Clinical trials (1,11,111,4) EDC Patient triage and… Show more FDA regulations including 21CFR Parts 11, 50, 54, 56 and theCommon Rule ICH E6 (R2) GCP (ALCOA-C) HIPPA regulations Regulatory affairs (FDA Form 1572, Training logs, RegulatoryBinders, Protocol Investigator’s Brochure, DOA, Pre-Trial EssentialDocuments etc. Creating Source data Protocols and SOP’s compliance Assisting in recruitment and retention of research subjects Phases in Clinical trials (1,11,111,4) EDC Patient triage and follow up I/E criteria IRB approval and disapproval Data Management Systems (Data Collection, EDC, Laboratory DataEntry, Clinical Trial Management Systems etc.) CRF Assessment of concomitant medications Pre-screening and Screening of subjects Remote monitoring Monitoring, Quality Assurance, and Inspection Show less