Nancy La Rocco Email & Phone Number

River Forest, Illinois

1. Primarily responsible for developing, processing and tracking all regulatory materials for new and existing protocols. Follows Good Clinical Practice (GCP) guidelines within the Federal, State and Institutional regulations and laws. Contributes to positive outcomes and meets the cultural expectations of the organization by exhibiting professional behavior.2. Receives and reviews new protocols to be activated, amendments, addendum notices, suspensions and terminations from the research bases and pharmaceutical companies. Prepares documents for all submissions to the IRB such as new protocols, amendments or revisions to existing protocols, informed consents, adverse events reporting, drug safety reporting, annual renewals and various special submissions3. Acts as a liaison between the study sponsors, investigators and the appropriate oversight/regulatory agencies regarding the study status and process and serves as a resource to the clinical trials office staff on regulatory concepts.

Kenosha, Wi

1. Prepare clinical study start-up documents per the Sponsor/CRO request2. Prepare and submit reports to the IRB (status reports, change request reports, protocol deviations)3. Communicating with Sponsor/CRO regarding the status and completion of required clinical start-updocuments and any critical regulatory issues.4. Maintaining and reviewing of study file binders prior to monitoring visits and site audits in order to ensure site compliance5. Ensuring all study staff is compliant with required clinical trial training6. Submit protocol deviations, SAEs and AEs requested by Sponsor or IRB in a timely manner7. Assist study monitors by resolving open issues by following SOPs and preparing NTF (Notes to File)8. Complete all require documents in order for a smooth close out visit.

Lake Forest, Illinois

1. Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval2. Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports)3. Review/approval of engineering study protocols/reports and validation study protocols/reports. Knowledge of FDA 510k guidance documents and CFR regulations4. Assist in monitoring and reporting project timelines. 5. Organize materials from preclinical and clinical studies for review and assist in review process. 6. Coordinate and assist in the preparation of submission packages, oversee quality control of regulatory documents. Assist in preparation of routine reports and regulatory agency communications.

Waukesha, )

Work with a team of Regulatory Affairs professionals to ensure completion of Product Controllership and UDI deliverables in the area of product remediation and new product development. 1. Create Registration program records for US registered products in the IRIS database2. Create US country records for each registration program in IRIS3. Complete UDI attributes for each US country record (includes identification of data values via existing 510(k) records) in IRIS4. Collaborates with product engineering and marketing to establish Product Models based on regulatory filings5. Completes association of Product Models to US country records in IRIS

Lake Forest, Il

Global Regulatory Affairs Department- Support global device registration tracking project including researching, organizing, collating.- Entering international registration data as well as device definition criteria. - Efficiently data mine database applications such as SAP, Enovia, and RegiSTAR. - Support ordering Certificates of Free Sale, legalizing documents and filling other global regulatory device submissions.

675 Field Drive, Lake Forest, Il

1. Facilitate the execution of Confidential Disclosure Agreements and Clinical Research Areements for all clinical studies and maintains the Master department files.2. Responsible for entering requests for budgetary approval and tracking Agreements in eContract3. Tracking status of PO and ACR payments for department and /in CTMS 4. Manage ACR payments in Symphony5. Maintains and updates quarterly status reports for Clinical Agreements6. Preforms denied party screening reports and financial disclosure7. Support the Director of Clinical Research and the Clinical Monitors, as needed

Abbott Park, Il

• Evaluation of regulatory submission or approval data submitted worldwide; resolve deficiencies through research or communication with the appropriate affiliate• Create submissions or update approvals in the registration data base (TRACTS)• Monitor and evaluate data in data base, identify issues and determine resolution• Responsible for accurate recognition and categorization of Regulatory submissions and regulatory documentation as well as comprehensive entry of all materials into the registration tracking database and related document systems.• Also have mastered a thorough understanding of the EU Regulatory (Centralized Procedure and Mutual Recognition Procedure, Decentralized Procedure) and EU National Clinical Trials Application submission structure and content.

Provided direct support to Associate Directors and External Research Grants Department.• Reviewed new Investigator Initiated proposals, budgets and drug calculations• Trained and collaborated with Research Scientific Managers to ensure protocol submissions are complete• Reviewed study milestone reports, abstracts and manuscripts to determine study relevance and necessity of payment• Lead contact in establishing requirements for rebuild of Siebel tracking database• Prepared documents and meeting minutes for External Research Grants Committee meetings• Assisted in the development of written team procedures and Standard Operating Procedures• Prepared study contracts • Maintained study budget• Distributed payments based on study milestones• Coordinated drug shipment release

• Provided strategic planning in collaboration with Project Managers to initiate study start-up • Managed metric tracking of regulatory documents for multi-site trials• Participation on SOP Development Team relative to regulatory requirements, including staff training• Management of secured Master Files• Conducted quality control reviews on master files prior to data locks• Regulatory expert used to review protocol, all regulatory documents displayed at Investigator meetings• Presented regulatory training surrounding applicable GCP's and ICH guidelines for Investigators• Assisted Project Managers with tracking site subject enrollment and data management