• Initiates all IRB submissions: new protocols, amendments, renewals, and closures. Completes all IRB submission forms and letters and serves as a liaison between IRB and Sponsors, as appropriate, during the IRB approval process. Responsible for all responses to post-I RB review correspondence. Ensures effective communication of new approvals, amendments, and closures post-IRB-review to all internal and external stakeholders.• Responsible for drafting all study Informed Consent Forms in compliance with IRB form templates and procedures. Maintains all IRB form templates in conjunction with the evolving language set forth by IRB, including maintaining the glossary of terms for IRB consent forms. Drafts and submits AE/SAEs in accordance with Sponsor and IRB timelines. Files and submits IND safety reports to the IRB if they meet IRB reporting requirements. Works with clinical CRAs/CRNs to obtain accurate information as needed.• Assists in the development and preparation of Investigator Initiated Trials (IIT).• Compiles regulatory submissions of IND applications, including annual reviews and communication of significant amendments.• Prepares and/or oversees all the regulatory submissions for grant applications.• Conducts quality reviews of regulatory documents to ensure compliance.• Assists in the process of contract and budgeting as requested.• Serves as liaison and assists with study specific site questionnaires, CDAs and CT as; maintains protocol pipeline log and communicates with Sponsors as appropriate to expedite all pre- IRB submission processes.

• Responsible for the coordination and management of assigned clinical research studies from inception to conclusion. Coordinate study-specific specific regulatory documentation across multiple studies of various therapeutic areas and phases, in accordance with appropriate GCP and ICH regulations, Standard Operating Procedures (SOPs), and study-specific protocols and processes.• Collaborate and effectively communicate with cross-functional teams within CNS and with CNS affiliates as required to ensure implementation of the regulatory aspect of clinical research studies.• Management of 6 + Regulatory Staff for all protocols from feasibility to close-out.• Management of Study Start-up process for Southern California Offices.• Coordinate/Manage/Track Confidentiality Agreements between Southern California offices and CROs/Sponsors. • Research/contract vendors (IRBs, imaging facilities, labs, physicians, etc.) for study-specific procedures/tests.• Provide regulatory expertise and guidance to the cross-functional teams on regulatory policy, standards, trends, and requirements• Prepare company SOPs, periodic SOP reviews for adherence to industry requirements and federal regulations. • Represent CNS to sponsor representatives and regulatory agencies. • Preparation of investigator site files for regulatory agency audits.• Assist the Quality Assurance Department in the effective resolution of site deficiencies.• Assist the Training Department with the implementation/development of company processes and policies.• Assure staff compliance with certification and training (GCP, HSP, HIPAA, Protocol specific, etc.) requirements.• Develop informed consent documents for early phase research studies. • Develop/review company regulatory documents and pre-screen materials.• Maintain communication and exchange of regulatory and sponsor documentation

• Facilitated site initiation visits, interim monitoring visits, close-out visits, pathology training, on-site and remote data monitoring review for external reproducibility and clinical studies. • Managed clinical research organizations and ensured monitoring of studies, data collection, and handling.• Verified the required clinical data entered in the case report form (CRF) was accurate and completed via review of site source documents and medical records. • Applied query resolution techniques remotely and on-site, and provided guidance to site staff as necessary, driving query resolution to closure within agreed timelines.• Provided assistance to CRA’s in scheduling required training for pathologists.• Conducted source document review of appropriate site sources and regulatory documents. • Routinely reviewed investigator site file (ISF) for accuracy, timeliness, and completeness.• Reconciled content of the ISF with the Trial Master File (TMF) and archiving.• Reviewed monitoring reports, tracking the progress and timeline of studies. • Led clinical projects requiring coordination with other functions and third parties. • Assisted in revising or updating PO’s, SOW/ Contract.• Coordinated ethical committee and institutional review board notifications. • Managed testing laboratories, including the selection of laboratories for the study.• Prepared, revised, and maintained procedures for the conduct of investigations.• Study indication assigned: small cell lung cancer (SCLC), biliary tract adeno cancer (BTAC), and endometrial cancer.