This Job Description provides a summary of the duties and/or characteristic of work performed and is not inclusive of every detail of the job for every individual assigned to the position. This description will be reviewed periodically and revised as duties and responsibilities change with business demands. Other duties not listed above may be assigned as needed.

Brief Description:
The Senior Clinical Research Associate (Sr. CRA) will be a member of the Monitoring team. The Sr. CRA will provide Monitoring expertise to individual clinical trials and/or programs.

Essential Functions for in-house and outsourced studies when assigned
• Conduct and provide support for in-house and outsourced clinical site monitoring activities to ensure adherence to Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs) and study protocols
• Collaborate with study teams during start-up/feasibility, and conduct site identification and assessment tasks.
• Identify root causes and proactively escalate and resolve CRA and site performance issues through collaboration with stakeholders
• Provide Monitoring expertise, mentoring and training to less experienced team members as required
• Build positive working relationships and proactively seek feedback from site teams (e.g., Principal Investigators, Study Coordinators, Pharmacists, Site Administration)
• Partner with study teams and sites in conducting site outreach activities, including patient recruitment and retention strategies
• Provide input and lead cross-functional teams through the process to determine monitoring strategy (risk-based monitoring) for studies as required
• Use regional knowledge to localize study processes and documents where possible
• Represent Monitoring at Investigator Meetings as required
• Perform other tasks as required

Required Knowledge, Skills, and Abilities
• At least 5 years relevant clinical research experience (i.e., biotechnology, pharmaceutical, Contract Research Organization (CRO), medical device)
• Travel as required, to include domestic and international
• Demonstrates working knowledge of GCP, ICH guidelines and FDA regulations
• Demonstrates ability to work independently and in a team environment
• Proficiency with MS Office 365 (e.g., Word, Excel, PowerPoint, Outlook, SharePoint)
• Excellent oral and written communication skills and strong organizational abilities

Required/Preferred Education and Licenses
• BA/BS, nursing degree, or advanced degree. Degree in the life sciences preferred
• Experience in CNS and / or oncology
• Ability to speak and understand multiple languages
Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.

At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. Advanced Group is committed to providing employment opportunities without regard to sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.

Advanced Group complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, please contact [email protected].