Associate Clinical Trials Administrator

Associate Clinical Trials Administrator PROCEPT BioRobotics Corporation - 3.0 San Jose, CA Job Details Full-time $82,110 - $96,600 a year 1 day ago Benefits Opportunities for advancement Qualifications Productivity software Technical Proficiency Full Job Description Company Overview Embark on an enriching journey with PROCEPT BioRobotics, where our vision, mission, and values guide everything we do as a company. At PROCEPT, we put the patient first in everything we do and are committed to revolutionizing treatment for benign prostatic hyperplasia (BPH, otherwise known as prostate gland enlargement) through innovation in surgical robotics. As our company succeeds and grows, we improve the quality of life of patients, provide more effective treatment options for surgeons, uphold the trust of our shareholders. That starts with a commitment to our People with a focus on creating an evolving landscape for your career, brimming with transformative opportunities that provide continuous career growth opportunities. Understanding PROCEPT's Culture At PROCEPT, we believe every person matters. Every employee, every patient, every caregiver. Because we are here to create a revolution, and we believe in doing that by innovating everywhere with pathological optimism. We believe in being humble and highly engaged in the work we do, while also working together seamlessly for a common goal. At Procept, curiosity, ingenuity and conviction in the power technology will transform the lives of our patients and providers. And this doesn't happen by accident. It starts with our live induction program that serves as an incubator for cross-functional team building, an immersion in Procept's history, jam-packed interactive sessions with executive leadership and a crash-course in the mission and purpose of what we do. It continues with our one-of-a-kind management program designed to build the best managers in the industry, where our people managers across functions come together to exchange ideas and grow, as both managers and learners, in an environment that challenges, supports and broadens. We are fueled by the opportunity to give people their lives back. And we believe that it begins with YOU! At Procept, we push beyond just finding a work/life balance, we strive to find a work/life blend, a professional world that you are honored and impassioned to belong to, one that you can proudly share with your family, friends, and acquaintances. An opportunity at PROCEPT BioRobotics won't just be about finding a job. It will be an opportunity for you to join a community devoted to making a difference in this world! The Opportunity That Awaits You The Associate Clinical Trial Administrator provides the Clinical and Medical Affairs team with general administrative support responsibilities. What Your Day-To-Day Will Involve Updates the clinical project progress using tracking tools provided by the project leads from the Clinical and Medical Affairs team. This includes but is not limited to clinical study progress, Trial Master Files (TMFs), study essential documents, vendor and site payments, etc. In some cases, assists in the structure development of the tracking tools. In charge of the Engineering Change Order (ECO) process for documents created or updated by the Clinical and Medical Affairs team. This includes creating the ECO number, initiating the ECO, and following up all the way through the document release. Might also help with creating redlined documents and drafting the change history under the supervision of the project lead. Prepares, packages, and sends documents and materials to clinical trial sites and vendors as needed. Receives and reviews clinical study documents (including regulatory documents) from clinical trial sites for accuracy and compliance with company SOPs, ISO standards, industry guidelines and regulations. Ensures all trackers are updated timely and accurately. Archive historical versions of the trackers appropriately. Reviews all invoices from vendors and clinical trial sites related to Clinical and Medical Affairs for accuracy per executed contracts. Communicate with vendors and clinical trial sites for any discrepancies on the invoices. Obtains approval from internal approvers and forwards the invoice together with the approval to the accounting team for payment process. Follows up with the accounting team regularly for payment status updates. Assists with the organization and management of internal team meetings, investigator meetings, and other clinical trial-specific meetings. Performs general support to the Clinical and Medical Affairs team as needed. Maintains trained status for, and complies with, all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory compliance. Understands and adheres to the PROCEPT BioRobotics Quality Management & EHS policies. The Qualifications We Need You to Possess To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Bachelor's degree in a scientific or health care discipline preferred and/or training; or equivalent combination of education and experience 1-2 years' experience in the medical device industry with involvement in clinical research activities preferred Superb verbal and written communications skills Excellent organizational skills along with strong attention to detail Ability to work both independently and collaboratively in a team environment Highly proficient with Microsoft office Suite Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs Ability to utilize critical thinking to analyze problems which may require multiple factors and approaches Pay Range for this role: $82,110 to $96,600