Senior Clinical Research Associate - US - West Coast - FSP
Parexel
Summary
The Clinical Research Associate (CRA) will be a member of the client's Monitoring team and provide monitoring expertise to individual clinical trials and/or programs.
Job description
Key Accountabilities
Oversight of activities
- 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
Collaborative relationships
- Collaborates effectively with study teams and stakeholders to conduct site assessments, identify performance issues, and implement solutions that align with project goals and operational efficiency.
Skills
- Ability to travel domestically
- 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
Knowledge and Experience
- Relevant clinical research experience (i.e., biotechnology, pharmaceutical, Contract Research Organization (CRO), medical device)
- Demonstrates working knowledge of GCP, ICH guidelines and FDA regulations
- Experience in Oncology preferred
- 5+ years of relevant monitoring experience
Education
- BA/BS, nursing degree, or advanced degree. Degree in the life sciences preferred
Requirements
- 5+ years of relevant monitoring experience
- Relevant clinical research experience (biotechnology, pharmaceutical, CRO, or medical device)
- Working knowledge of GCP, ICH guidelines and FDA regulations
- BA/BS, nursing degree, or advanced degree
- Ability to travel domestically
- Proficiency with MS Office 365
- Excellent oral and written communication skills
- Strong organizational abilities
- Ability to work independently and in a team environment
- Experience in Oncology preferred
- Degree in the life sciences preferred
Company overview
Parexel is one of the world's largest and most prominent contract research organizations (CROs), providing comprehensive clinical research services to pharmaceutical and biotechnology companies globally. Founded in 1982 and headquartered in Raleigh, North Carolina, Parexel operates with a global workforce of over 24,000 professionals across 84+ facilities in 49 countries. The company specializes in managing the full spectrum of clinical trials from Phase I to IV across diverse therapeutic areas including neuroscience, oncology, infectious diseases, hematology, and general medicine. Parexel offers end-to-end solutions encompassing clinical trial management, regulatory strategy, data management, biostatistics, pharmacovigilance, medical communications, and market access consulting. With a strong track record spanning over 40 years, Parexel has established itself as a trusted partner for both established pharmaceutical leaders and emerging biotech innovators, helping accelerate drug development and bring life-saving treatments to patients faster through its patient-centric approach and operational excellence.