Clinical Trial Associate

The Clinical Trial Associate (CTA) will provide administrative support to the Clinical Operations Team in full spectrum of clinical trial activities related to study start up, study maintenance, study closure and vendor management in compliance with Good Clinical Practice (GCP), Standard Operation Procedures (SOPs), and all applicable regulations governing the conduct of clinical trials.Essential Duties and ResponsibilitiesThe main responsibilities of this role include but not limited to the following:Supports with reviewing, formatting, and finalizing clinical protocols and other key study documents such as reports, Study Master ICF Template, etc.Provides administrative support with various tasks such as review and formatting of documents including follow-up on various tasks, updating project timelines, etc.Develop and maintain study tools and trackers (e.g., study contact lists, study vendor contract tracking, site visit report completion, sample management)Route and track approval forms for essential study documents (e.g., informed consent, study plans, etc.)Submit study agreements, contracts, budgets for assigned studies to the finance team Request country-level clinical trial liability insurance certificates for assigned studiesProvide Regulatory Affairs with copies of the 1572/Investigator Statement of Compliance and Financial DisclosuresCollaborate with eTMF Owner to draft and finalize the eTMF Plan and Expect Document Lists (EDLs)Oversee TMF filing, which may include reviews and reconciliation activities.Ensures correct filling of Site Essential Documents review during study start-up, maintenance, and close-out periodRoutinely participates in department and clinical trial team meetings and participates in collaborative efforts (e.g., protocol development, CRO selection, departmental initiatives, etc.) Review monitoring reports for clinical sites across all studies. Perform QEVs if necessary, at clinical sites. Provide initial and ongoing study information in support of clinical trial registration (e.g., Clinical Trials.gov)Execute ad hoc study-related administrative tasks assigned by Study LeadRecommend modifications to SOPs when necessary to improve compliance or efficiency.Comply with assigned SOPs and applicable plans, guidelines, and standards.In addition to Key Duties and ResponsibilitiesMay perform QC (formatting, spelling, grammar, accuracy, consistency) of study related documents (ICFs, study plans, etc.) in alignment with study protocols.May contribute to the development of study related documents (study plans, study templates, investigator site file materials, newsletters, etc.)May function as a point of contact between clinical vendors as delegated by Study LeadMay participate in SOP development and revisions.Provides administrative support with various tasks such as review and formatting of documents including follow-up on various tasks, updating project timelines, etc.Other duties as assigned.