Our early stage start-up client is adding a Senior Clinical Research Associate to the team. The Sr. CRA assists with the planning and development of high-quality clinical activities to support projects. The Sr. CRA has strong clinical research experience, and a strong understanding of research methodology, regulations, and guidelines. The Sr. CRA has experience assisting with the development of clinical strategies and/or plans, protocol development and execution, monitoring, and ensuring data quality and management of clinical studies. The Sr. CRA is recognized as a subject matter expert with CROs and other vendors in the execution of clinical trials and interacts with study investigators and other study staff members. The Sr. CRA will monitor clinical research sites in accordance with FDA Regulations, other global regulatory bodies, GCP and ISO compliance, and company SOPs.

Your role with the company:

• Supports and executes clinical trials in collaboration with other clinical team members pertaining to site qualification, initiation, site management, data management and other ongoing tasks to support clinical trials.
• Perform site activities in compliance with GCP and FDA regulations for clinical trials
• Assist with the development of study related documents including case report forms, study manuals, and other study related tools.
• Assists with data management activities, query generation and resolution.
• Reviews informed consent forms and site activation documentation.
• Assists in planning and preparing materials for investigator and coordinator meetings.
• Communicates site status with Investigators and internally by reporting study metrics, e.g. subject screening and enrollment, data collection, documentation of adverse events.
• Assists with preparation of study summary reports for presentations, publications and regulatory submissions.
• Provide input to the data management plan, monitoring plan, safety plan and other study-specific plans.
• Conducting pre-study, initiation, routine (as needed to ensure protocol compliance), and close-out site visits
• Acts as a subject matter expert training study coordinators/investigators on protocol including study procedures, CRF completion, enrollment, and informed consent, and study product.
• Working with staff at study sites to resolve data discrepancies.
• Obtaining/reviewing/processing of regulatory and study-specific documents from investigative sites.
• Maintaining investigational product accountability.
• Monitoring IRB requirements.

Desired Profile:

• 5+ years’ experience supporting clinical research or similar experience in a medical and/or scientific area; (Bachelor’s degree in medical/and or scientific area preferred)
• Master’s degree will substitute for 1 year of experience.
• In-depth knowledge and proficient in FDA regulations and ICH/GCP guidelines
• Conducts highly complex work, unsupervised and with extensive latitude for independent judgment
• Ability to anticipate and meet deadlines, prioritize work, strong attention to detail, and the ability to retain confidential information.
• Proficiency in MS Office, including PowerPoint, Excel and Word.
• Must be customer service oriented with strong interpersonal skills.
• Excellent organizational, written, and verbal communication skills
• Effectively build and maintain positive relationships with physicians, peers, and colleagues across all organizational levels
• Ability to multitask effectively while maintaining high quality outputs

Nice to Have:

• Proven experience working with OUS First in Human (Latin America) and FDA IDE pre-market clinical studies
• Strong knowledge and understanding of sleep disordered breathing

Working Conditions:

• Significant work pace and pressure due to deadlines of a start-up organization
• Travel will be required 25-50% depending on project life-cycle
• Position based in Minneapolis, MN