Clinical Trial Associate

Education and Experience Requirements

• Bachelor’s degree in a related or similar field
• Minimum of one-year relevant clinical trial experience in the pharmaceutical and/or biotechnology industry.
• Prior experience as a CTA and/or knowledge of FDA, ICH, GCP, CFR guidelines, regulatory requirements, and clinical trials operations.

• 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 studies
• Provide Regulatory Affairs with copies of the 1572/Investigator Statement of Compliance and Financial Disclosures
• Collaborate 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 period
• Routinely 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 Lead
• Recommend 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 Responsibilities
• May 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 Lead
• May 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.