Sr. Clinical Trial Associate

Kardigan • Full-time • Princeton, New Jersey, United States • 7h ago

About Us

Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world.

It is Kardigan’s mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve.

Led by Tassos Gianakakos, Jay Edelberg, M.D., Ph.D., and Bob McDowell, Ph.D., Kardigan’s co-founders have reunited after leading MyoKardia to discover and develop mavacamten, the first cardiac myosin inhibitor, resulting in an acquisition by Bristol Myers Squibb in 2020.

We have a cutting-edge discovery and translational research platform, a pipeline of late-stage candidates, and an industry-leading team that is driven to improve the lives of patients.

At Kardigan, we are motivated by our values which guide how we work, interact, and achieve our goals. Driven by patients and their families, we are deeply committed to improving the lives of patients and prioritizing their needs above all else. We believe in being authentic—leading with truth to bring out the best in others by creating an environment where every person knows they will be fully accepted. With an eagerness to learn, we encourage the highest levels of curiosity and are open to changing our minds. We are committed to winning as a team with urgency, excellence, and intention, and support each other no matter what role we play or where we sit. Lastly, we strive to enable the impossible because patients are counting on us. We are not afraid to take risks to unlock innovation and advance scientific discoveries.

These values are the foundation of our work, empowering us to make a real difference, every day.

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