Senior Clinical Research Associate
San Carlos, CA 94070
Senior Clinical Research Associate
San Carlos, CA
The Senior Clinical Research Associate is a critical position within the clinical team. In close collaboration with the Clinical Trial Manager and/or Study Director, the Sr. CRA will work to manage and provide daily operational oversight of Contract Research Organization (CRO), study vendors, and clinical trial sites. The Sr. CRA will partner with the Medical Monitor and other internal and external constituents to ensure clinical trial activities and deliverables are completed on-time and in accordance with regulatory requirements, Good Clinical Practice (GCP) guidelines and company SOPs.
- Independently manages the study start up activities for multi-center, US and/or global based studies.
- Performs on-site visits (feasibility, SIV, IMV, Close-Out) with CRO CRAs as needed to assess the sites’ and CRA’ s overall performance
- Provides monitoring oversight by reviewing monitoring schedules, metrics and reports.
- Responsible for the clinical site training and sites adherence to protocol, all applicable GCP/ICH guidelines, regulations statutes and SOPs.
- Leads or participates in vendor management activities (e.g. Central Laboratory, Central Imaging, CRO)
- Performs in-house routine data listings review
- Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
- Supports CTM and cross-functional representatives as required in relationship management tasks (e.g. contracts, study logistics, patient enrollment, safety, data management, etc.) to accurately coordinate clinical study activities.
- Mentors and coaches junior staff new to Clinical Research (e.g. Clinical Trial Assistants)
- Assists with the development of protocol writing, informed consent development, CRFs, monitoring conventions, tracking forms, and other study related documents
- Assists in managing and/or leading the day-to-day operations of assigned studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.
- Performs other duties and assignments as required for the overall success of the projects.
- Duties may change based on the status of clinical programs and the ongoing needs of the organization.
- BS/BA, RN, or equivalent with at least 4 years of clinical trial monitoring / clinical trial management and vendor experience in accordance with CFR, GCP and ICH Guidelines
- 4 to 8 years' industry experience
- Must have strong knowledge of ICH/GCP guidelines
- Must have strong knowledge of protocol and clinical drug development processes, clinical study design, study planning and management, and monitoring
- Strong experience managing early to late phases clinical studies and working with CROs and other study vendors
- Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability
- Excellent organizational, record retention, time management, decision making, customer service, and interpersonal skills. Good command of written and spoken English language
- Excellent computer skills in the following programs: MS Word, PowerPoint, Excel and Project
- Ability to “ roll up your sleeves” and individually contribute results to a research and development effort
- Ability to travel up to 25%
- Sit for an extended time in front of a computer