Clinical Trial Assistant

Job description

Primary Function of Position

The Clinical Trial Assistant will play a key role to provide 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. The ideal candidate will have good understanding of clinical trials regulatory requirements. This position is based at the Intuitive Surgical Headquarters in Sunnyvale, California.

Roles & 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 vita, etc…), trip reports, site contact documentation, 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, non-disclosure agreements, etc
• 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, recruitment materials, etc.
• Collaborate with Clinical Study Managers (CSM) to develop clinical study informational materials such as newsletters, recruitment materials, etc
• 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

Qualifications

Skills, Experience, Education, & Training

• 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, clinical project coordination
• Proficient in MS Office suite, Adobe, video and web conferencing solutions Clinically savvy & good knowledge of basic medical terminology preferred Possess working knowledge of Good Clinical Practice as detailed in 21CFR and ISO 14155, and regulation such as 21 CFR Part 812
• Minimum of 2-4 years of related experience in clinical research with high school diploma or secondary education or equivalent Minimum
• Bachelor’s degree is a plus Research/clinical trial management certification/ education is a plus Able to travel up to 10% We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits and equity, and 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 range for the role, as actual pay will be determined based on several factors, including location, skills, and experience level