Clinical Trial Associate

The Position

The Clinical Trial Associate (CTA) provides administrative support to the Clinical Operations Department. The primary purpose of the position is to facilitate efficient clinical trial planning and execution.

Responsibilities

• Develop and maintain study tools and trackers (e.g., study contact lists, study vendor contract tracking, site visit report completion, sample management)
• Update periodic clinical study and portfolio overview reports provided to senior management
• Route and track approval forms for essential study documents (e.g., informed consent, study plans, etc.)
• Submit and track study agreements, contracts, budgets for assigned studies
• Obtain/assign investigative site identification numbers
• 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
• Request study set-up in Veeva Vault and system access for study team members
• Collaborate with eTMF Owner to draft and finalize the eTMF Plan and Expect Document Lists (EDLs)
• Perform TMF filing, which may include reviews and reconciliation activities
• Assign and track study specific training for all Clin Ops team members based on the core curriculum
• Manage off-site document storage and retrieval as applicable
• 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
• Assist in the planning and coordination of meetings including logistics, agenda preparation and distribution of meeting minutes and meeting materials
• Participate in Clinical Operations department initiatives and other duties as assigned
• Recommend modifications to SOPs/WIs when necessary to improve compliance or efficiency
• Comply with assigned SOPs/WIs 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/WI development and revisions

Requirements

• Strong organizational skills and attention to detail
• Ability to multi-task and prioritize effectively with input from manager or Study Lead
• Proficient interpersonal, verbal and written communication skills
• Ability to work effectively independently and in a collaborative team environment
• Basic software skills (MS-Outlook, Word, Excel, DocuSign)
• Proficiency in Veeva eTMF
• Ability to perform Key Duties and Responsibilities in a timely manner and with minimal supervision
• Basic understanding of Good Documentation Practice (GDP) and ICH-GCP
• Ability to readily identify and categorize essential document types as defined by ICH E6 for submission to TMF
• Consistently exhibits critical thinking skills

Preferred

• 4-year college degree preferred
• At least 1 year experience in similar industry position or equivalent work experience