Clinical Trial Assistant

About the Role

The Clinical Trial Assistant will play a key role in providing operational support to coordinate the conduct and management of clinical studies to ensure compliance with Intuitive standard operating procedures, Good Clinical Practices (GCP), good documentation practices, and applicable regulations. This position is based at the Intuitive Surgical Headquarters in Sunnyvale, California.

Responsibilities

• Coordinate and manage the ordering, shipping, labeling, and tracking of study supplies (including investigational products) with limited supervision.
• Establish, organize, and maintain trial master file and clinical trial management system to ensure regulatory and protocol compliance, including maintenance of study essential documentation (e.g., correspondence, CRFs, study approval documents, curriculum vitae, etc.), trip reports, site contact documentation, and monthly status reports (e.g., enrollment, adverse events, budget, etc.).
• Contribute to operational excellence and continuous improvement.
• Maintain, track, and facilitate routing for approval and signature of clinical study documents including protocols, case report forms, informed consents, clinical trial agreements, and non-disclosure agreements.
• Create purchase requests and process invoices.
• Support clinical study manager with study budget tracking and payments of clinical sites and vendors.
• Prepare and ship site binders and patient binders as necessary.
• Contribute to creating clinical study informational materials such as newsletters and recruitment materials.
• Collaborate with Clinical Study Managers (CSM) to develop clinical study informational materials such as newsletters and recruitment materials.
• Collaborate with Clinical Research Associates (CRA), Clinical Study Managers (CSM), and Clinical Managers to support study execution.
• Provide administrative support to coordinate, schedule, and plan study and investigators meetings, teleconferences, distributing agendas, and meeting minutes.

Requirements

• Excellent communication, organization, and interpersonal skills with strong attention to detail.
• Strong ability to organize, prioritize, and manage multiple priorities.
• Prior experience in medical device clinical trials, regulatory support, or clinical project coordination.
• Proficient in MS Office suite, Adobe, video, and web conferencing solutions.
• Clinically savvy with good knowledge of basic medical terminology preferred.
• Working knowledge of Good Clinical Practice as detailed in 21 CFR and ISO 14155, and regulations such as 21 CFR Part 812.
• Minimum of 2-4 years of related experience in clinical research with a high school diploma or secondary education or equivalent.
• Able to travel up to 10%.

Qualifications

• Minimum Bachelor’s degree is a plus.
• Research/clinical trial management certification/education is a plus.

Pay

The anticipated pay rate for this position is $70,000 to $94,800. It would not be typical for someone to be hired at the top end of the range for the role, as actual pay will be determined based on several factors, including location, skills, and experience level.

Schedule

Day shift. This job is fully onsite.

Due to the nature of our business and the role, Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.