Carly G.

About Carly G.

Experienced clinical research professional with demonstrable analytical and investigative skills specifically trained in phase 2, 3, and real world/late-phase research designs (e.g, therapies including oncology and gastroenterology). Ability to work with the project team to support the management of investigative sites. Responsibilities include investigative site recruitment, essential document collection and review, clinical status tracking, regulatory submissions, site management, and data review activities in accordance with the study protocol, client and/or company SOPs, and all applicable guidelines and regulatory requirements.

Experience

1. Senior Clinical Trial Associate

   Aperio Clinical Outcomes

   Apr 2025 — Present · Conshohocken, PA, US

   Secondment to Immunocore Ltd.• Assists with review of Site Contracts, Site Budgets, and Site CDA’s • Evaluates and approves regulatory documents required for Local/Central IRB Submissions, EC Submissions, through Investigational Product greenlight/ release • Assists in providing oversight & accountability to third party vendors assigned to a study or program • Ensures TMF Inspection readiness by assisting with creation of TMF Index and TMF Plan, as needed, conducts periodic TMF document content review for completeness, ensures documents are filed in the correct locations and file naming conventions are correct, assists with quality reviews of TMF• Assists in the archiving of study documentation for the TMF • Helps with coordination of Meetings, and responsible for Agendas, and Meeting Minutes • Assists in tracking milestones, generating study metrics, and providing written and verbal updates to Management • Liaises with Clinical Project Manager and/or others to resolve study related discrepancies and issues • Post disclosure of trial information on publicly accessible websites (e.g, Clinicaltrials.gov) • Ensures adherence to pertinent regulatory requirements and to departmental polices, practices and procedures. Ensures knowledge is kept up to date by reading SOP’s and maintaining awareness of GCP guidelines • Ensures program meets all GCP/ICH Guidelines and is Inspection Ready • Assists in publishing of Clinical Trial documents, such as Protocols and Amendments, Investigator Brochures, Lab Manual and other study related documentation, as needed • Prepares and distributes supportive documents needed by Investigator Sites, and other internal departments • Creation of Purchase orders for Clinical Operations vendors, as needed • Assists in SOP and working instruction development, review and approval within the company • Identifies and communicates study issues that will impact budget, resources and timelines

Education

• Temple University

  Bachelor of Science - BS, Public Health

  2018

• West Chester University of Pennsylvania

  Master of Public Health - MPH, Environmental Health

  2018 — 2020