LiveCareer-Resume

compliance analyst resume example with 15+ years of experience

Jessica Claire
  • Montgomery Street, San Francisco, CA 94105 609 Johnson Ave., 49204, Tulsa, OK
  • Home: (555) 432-1000
  • Cell:
  • resumesample@example.com
  • :
Summary
Ten years progressive experience in sponsored clinical research and development. Working knowledge of the technical and functional elements of Global HCP Spend Transparency/Aggregate Spend reporting requirements including but not limited to compliance, legislation (e.g. Physician Payment Sunshine Act), data sources/quality, and reporting. Experience working with cross-functional teams and demonstrated ability to partner effectively with others. Qualified project manager and team leader. Proven ability to work independently and deliver under strict timelines with minimal supervision. Ability to manage multiple priorities and adjust workload as business needs require. Outstanding attention to detail with a commitment to data quality. Ability to interpret legal documentation and draft reports with key outputs. Experience in the development of data capture applications. Extensive experience using external and internal research and mining. Experienced writer and editor with exceptional communication skills.
Highlights
MS Office Suite including Excel pivot table experience.
Accomplishments
Experience
Compliance Analyst, 06/2014 to Current
Autotask Corporation, ,
  • Detailed review and remediation of individual payments or transfer of value to healthcare professionals (HCPs) and healthcare organizations (HCOs).
  • Work with business areas to support the capture of HCP/O payments.
  • Assist in the filing of physician payments submissions in accordance with applicable laws, including the US Physician Payments Sunshine Act, French Final Decree, and similar statutes.
  • Monitor system alerts.
  • Partner with colleagues within functional areas to identify and resolve HCP/O spend data issues.
  • Responsible for responding quickly to requests for data analysis and research from Vertex functional areas.
  • Provide business with subject matter expertise on Global Spend Transparency requirements.
Clinical Trials Associate, 01/2013 to 01/2014
Glaukos, ,
  • Clinical Site Services (CSS) Provide support to CSS Lead in the oversight and management of start-up activities for clinical trials specifically in Cystic Fibrosis and Oncology.
  • Assist CSS Lead in activation of all study sites according to project timelines and support in the management of CRO study staff.
  • Responsible for informed consent form (ICF) development and management.
  • Manage the ICF amendment process including tracking of protocol and ICF amendments to applicable systems.
  • Perform comprehensive QC of regulatory documents.
  • Manage CRO ICF reviewers and assist in the documentation and review of study reports.
  • Create and maintain study-specific start-up trackers, tools and documents.
  • Attend all team meetings/teleconferences acting as back-up to CSS Lead, when necessary, by chairing start-up meetings with CRO.
  • Support CSS Lead in the customization of study specific contracts & budgets.
  • Assists CSS Lead in ICF, contract & budget and TMF QC reconciliation activities.
  • Provide training for CRO teams and the onboarding of new CSS staff.
  • Responsible for data entry of study-specific metrics and information into Invoke and Knowledge Management.
  • Confirm required study documents are submitted to the trial master file (TMF) or electronic document management repository (EDMS).
  • Accountable for ad-hoc data reconciliation for Vertex databases.
  • As subject matter expert (SME) and site owner for SharePoint (SP) built the CSS SP website.
  • Responsible for site content, access and permissions, migration of all documents and the training of CSS team members.
  • Initiative driven, personally created and maintained content for team collaboration on industry and Vertex specific topics such as the Vertex EPiC Initiative, striving to encourage thought-provoking, solution-based discussions on the site's "Today's Discussion in CSS".
Lead Writer and Editor Investigator Selection Due Diligence Specialist, 01/2007 to 01/2013
Alector, Inc., ,
  • Qualified Principal Investigators to participate in US and global clinical trials in accordance with ICH-GCP guidelines and regulatory processes.
  • Evaluated criteria for Investigator inclusion/exclusion per study protocols and made recommendations for trial participation supporting departments including Legal, Financial Disclosure, Worldwide Regulatory Affairs and Quality Assurance.
  • Reviewed and produced essential documentation for the Trial Master File relevant to Investigator qualification evidencing eligibility to conduct a trial.
  • Reported FDA findings and internal audit findings for inclusion to the TMF.
  • Developed, wrote and edited Due Diligence SOPs and process documents while working with Clinical Quality Assurance Leads to meet company standards.
  • Performed detailed background investigations by reviewing FDA, state[s] and internal databases verifying compliance and availability to participate in a sponsored clinical trial.
  • Completed quarterly Debarment Certification checks for IND submission.
  • Managed records retention including project tracking, FDA Restricted Listing, Debarment certifications, 1572 and Audit Listings, Worldwide Audit Management and Metrics Listing; updating all applicable databases.
  • Advanced working knowledge of FDA research databases including, but not limited to, Bioresearch Monitoring Information System, Clinical Investigator Inspection Audits, NIDPOE, NOOH, Warning Letter and Debarment listings.
  • As a member of the Corrective and Preventative Action team collaborated to develop new SOPs required by the FDA in remediation of company Warning Letter.
  • Acting as project manager, verified and resolved thousands of duplicate records in the detailed reconciliation of the Master Investigator database, completing the work prior to project deadline.
  • Contributed to the development and testing of new databases including Pfizer Clinical Trials Registry Management, Pfizer Trials Manager and the Site Selection Management Application.
  • Advanced training and working knowledge of regulatory requirements for Clinical Site Management and Monitoring including SOPs, ICH-GCP guidelines and FDA Regulations.
  • Maintained team mailbox: triaging requests while providing superior global customer service with sensitivity to confidentiality, strict and shifting timelines and language differences.
Clinical Trial Specialist, 01/2005 to 01/2007
Pfizer Inc, Global Research And DevelopmentCity, STATE,
  • Reviewed and maintained Adverse and Serious Adverse Event reporting for the Trial Master File within the global community.
  • Created efficient tracking systems for event reporting requests and data queries.
  • Generated sensitive and classified reports under strict guidelines and timelines.
  • Reviewed clinical case listings and processed according to company SOPs.
  • Maintained the Business Operations Support e-mailbox and distributed work to the team accordingly.
Education
Bachelor of Fine Arts: , Expected in to Emerson College - ,
GPA: cum laude
cum laude
Skills
ad, back-up, budgets, budget, Business Operations, clinical trials, content, contracts, CSS, customer service, data analysis, data entry, databases, database, document management, documentation, Due Diligence, filing, Financial, French, functional, GCP, IND, Inspection, internal audit, Knowledge Management, Legal, meetings, access, Excel, MS Office Suite, SharePoint, migration, Oncology, pivot table, processes, protocols, Quality Assurance, Regulatory Affairs, regulatory documents, reporting, research, Vertex, website

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Resume Overview

School Attended

  • Emerson College

Job Titles Held:

  • Compliance Analyst
  • Clinical Trials Associate
  • Lead Writer and Editor Investigator Selection Due Diligence Specialist
  • Clinical Trial Specialist

Degrees

  • Bachelor of Fine Arts

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