
Kumquat Biosciences Inc.
Remote Jobs
2 Jobs
• Draft, review, analyze, and negotiate clinical related contracts, including clinical trial agreements (CTAs) and ancillary agreements (including SCCs, LOIs, DRAs, LRAs), informed consent forms (ICFs), master service agreements and related work orders, vendor and service contracts, IT agreements, consulting agreements, and confidential disclosure agreements • Liaise and effectively communicate with with key stakeholders including external parties, internal business units, and contract research organizations (CROs) • Assist General Counsel with ad hoc legal projects as needed
• Perform the day-to-day management of early phase clinical trials or support the study lead(s) on one or more complex global clinical trials. • Develop and execute clinical trial plans, including study timelines, budgets, and resource allocation. • Manage trial budgets, contracts, and vendor relationships. • Collaborate with investigators, clinical sites, and key opinion leaders to ensure successful trial execution. • Ensure the timely initiation, monitoring, and close-out of clinical trial sites, including the selection of qualified investigative sites. • Oversee patient recruitment and retention strategies, ensuring trial objectives are met. • Oversee vendors and investigative sites in the collection and management of clinical data to fulfill study objectives. • Proactively identify and mitigate risks and challenges throughout the course of the trial. • Ensure strict compliance with Good Clinical Practice (GCP) guidelines and relevant regulations. • Prepare for and manage audits and inspections by regulatory authorities.