Kardigan is seeking a Sr. Clinical Trial Associate (Sr. CTA) to support one of its late-stage cardiovascular clinical programs. As a Sr. CTA, you will report to the Clinical Trial or Program Lead to assist with the management and execution of one or more clinical studies. As the assigned Sr. CTA, you will work collaboratively across the trial-specific operations team(s) and the department to ensure deliverables are met according to the budget, timelines and quality standards (as defined by regulations, SOPs and ICH-GCP) with the overall goal of developing new and innovative treatments for cardiovascular diseases with unmet need.

Responsibilities

• Perform trial related responsibilities from startup through database lock by coordinating and tracking activities for protocol and SOP compliance as well as regulatory guidelines

• Support internal and external trial-specific operations team meetings by capturing meeting minutes, decisions and action items and following up with action item owners to ensure tasks are completed
• Assist with the oversight of CRO(s) and other study-related, third-party vendors to ensure study requirements and timelines are met
• Contribute to vendor and budget management through the review of vendor invoices for accuracy against budget and tracking vendor payments

• Participate in the completion and review of the RFPs in collaboration with the Clinical Program and/or Clinical Trial Lead

• Assist with preparing, editing, producing, tracking and routing clinical documents as required such as clinical protocols, Investigator’s Brochures, informed consents (ICF) and study operations manuals
• Support the review of CRFs, study guides and forms including participation in the EDC and IRT specification process and user acceptance testing (UAT)
• Manage and perform periodic reviews and QC of the Trial Master File
• Update registries and systems with study related information study as clinicaltrials.gov or EU CTIS
• Coordinate with the CRO and other functions (e.g. clinical supply chain, regulatory) on review of essential documents for site activation
• Assists with the development and production of presentations, reports and other study related materials.
• Prepares and assists with Investigator Meeting planning
• Performs other tasks and assignments as needed and specified by the Clinical Trial Lead and/or Clinical Program Lead

Here’s What You’ll Bring to the Table

• Bachelor’s degree in a relevant life science or healthcare-related discipline
• Approximately 4 years of clinical research support experience in a pharmaceutical, biotechnology, CRO or related environment (e.g. Clinical Site Coordinator)
• Knowledge of Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines.
• Excellent communication skills, both verbal and written.
• Ability to work independently and collaboratively, as required, in a fast-paced, team environment consisting of internal and external team members
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
• Experience with TMFs and performing periodic ad hoc, interim and end-of-study reviews/audits on paper and electronic TMFs for several trials to ensure TMF meets sponsor’s expectations (includes TMF reconciliation at study close-out)
• Experience interacting and collaborating with CROs and vendors. Performing TMF QC for Contract Research Organization (CRO) TMF and ensuring quality of the TMF.
• Experience with Microsoft PowerPoint, Excel, Word and Smartsheet
• Travel may be required