Senior Clinical Research Associate - US - West Coast - FSP

Location: Remote, REMOTE, United States of America, Alabama, United States, Alaska, United States, Arizona, United States, Arkansas, United States, California, United States, Colorado, United States, Connecticut, United States, Delaware, United States, Florida, United States, Georgia, United States, Hawaii, United States, Idaho, United States, Illinois, United States, Indiana, United States, Iowa, United States, Kansas, United States, Kentucky, United States, Louisiana, United States, Maine, United States, Maryland, United States, Massachusetts, United States, Michigan, United States, Minnesota, United States, Mississippi, United States, Missouri, United States, Montana, United States, Nebraska, United States, Nevada, United States, New Hampshire, United States, New Jersey, United States, New Mexico, United States, New York, United States, North Carolina, United States, North Dakota, United States, Ohio, United States, Oklahoma, United States, Oregon, United States, Pennsylvania, United States, Rhode Island, United States, South Carolina, United States, South Dakota, United States, Tennessee, United States, Texas, United States, Utah, United States, Vermont, United States, Virginia, United States, Washington, United States, West Virginia, United States, Wisconsin, United States, Wyoming, United States, Remote

Employment Type: Remote

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.

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

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