Associate Clinical Trial Administrator at PROCEPT BioRobotics – San Jose, California

Associate Clinical Trial Administrator

Company OverviewEmbark 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.
SUMMARYThe 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 follow up all the way through 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 to company SOPs, ISO standards, and industry guidelines.
• Ensures all trackers are updated timely and accurately. Achieve historical versions of the trackers appropriately.
• Reviews all invoices from vendors related to Clinical and Medical affairs for accuracy per executed contracts. Communicate with vendors 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 process update.
• Assists with the organization and management of internal team meetings, investigator meetings and other trial-specific meetings.
• Performs general support to the Clinical and Medical Affairs team as needed.

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.
• Bachelors 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

PHYSICAL DEMANDS & WORK ENVIRONMENT

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• To perform this duty the employee must have the ability to sit or stand at and operate a computer terminal and walk or travel safely within the facility. The employee may occasionally lift and/or move up to 15 pounds.

Compensation also includes an annual bonus, flexible time off, and RSUs at offer! Work Authorization Status: Citizen / Permanent Resident OnlyUnderstanding PROCEPT's CultureAt 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 doesnt happen by accident. It starts with our live induction program that serves as an incubator for cross-functional team building, an immersion in Procepts 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 wont 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! BENEFITS OF WORKING AT PROCEPT! PROCEPTs health and wellness benefits for employees are second to none in the industry. As an organization, one of our top priorities is to maintain the health and wellbeing of our employees and their families. We offer a comprehensive benefits package that includes full medical coverage, wellness programs, on-site gym, a 401(k) plan with employer match, short-term and long-term disability coverage, basic life insurance, wellbeing benefits, flexible or paid time off, paid parental leave, paid holidays, and many more!
EQUAL EMPLOYMENT OPPORTUNITY STATEMENTPROCEPT BioRobotics is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind on the basis of race, color, national origin, religion, gender, gender identity, sexual orientation, disability, genetic information, pregnancy, age, or any other protected status set forth in federal, state, or local laws. This policy applies to all employment practices within our organization. PAY RANGE TRANSPARENCYProcept is committed to fair and equitable compensation practices. The pay range(s) for this role represents a base salary range for non-commissionable roles or on-target earnings for commissionable roles. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, relevant certifications and training, and specific work location. Based on the factors above, Procept utilizes the full width of the range. The total compensation package for this position may also include eligibility for annual performance bonus, equity, and the benefits listed above. WORK ENVIRONMENTWell provide you training for, and ask you to maintain trained status for, and comply with, all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory compliance. We would also ask you to understand and adhere to the PROCEPT BioRobotics Quality & EHS policies.
PROCEPT BioRobotics Applicant Privacy NoticeWhen you submit an application on this site, PROCEPT BioRobotics collects the personal information you provide. This may include your name, email address, phone number, rsum or CV, LinkedIn profile, and any optional demographic information you choose to share, such as gender or ethnicity. We use this information to review your application and assess your suitability for the role. To learn more about how we handle personal information, including your rights under applicable privacy regulations, please read our full Privacy Notice at: [Privacy Policy].
$82,110 - $96,600 a year