Clinical Research Associate II

This is a fully remote position, open to applicants in United States.

📋 Description

• Take on the responsibilities of a primary Clinical Research Associate (CRA) and act as the site manager.

• Perform site visits, which include Pre-Study Site Visits (PSSV), Site Initiation Visits (SIV), Interim Monitoring Visits (IMV), and Close-Out Visits (COV).

• Establish and nurture relationships with essential site personnel.

• Oversee data quality and ensure patient safety through effective monitoring and site education.

• Fulfill all clinical monitoring duties in compliance with ICH-GCP guidelines, local regulations, and relevant Standard Operating Procedures (SOPs).

• Evaluate the safety and effectiveness of investigational products and/or medical devices.

• Conduct site visits to assess compliance with protocol and regulatory requirements, and prepare necessary documentation.

• Cultivate collaborative partnerships with investigative sites and study vendors.

• Deliver protocol and study training to designated clinical study sites.

• Maintain oversight of site performance by monitoring enrollment, Case Report Form (CRF) data entry, protocol deviation trends, and site-related issues.

• Mentor and train junior CRAs.

• Relay site performance updates to the Clinical Study Team.

• Conduct study-specific training sessions with the project team.

• Reconcile Serious Adverse Events (SAEs) and address discrepancies with study sites.

• Work together with the Clinical Study Team (CST) and clinical study sites to achieve study milestones.

• Participate in regional investigator meetings and site booster visits as necessary.

• Assist in audit and inspection preparation, ensuring quality findings are resolved.

• Offer site-level management and co-monitoring support.

⛳️ Requirements

• Bachelor’s or Master’s degree in a relevant scientific field.

• A minimum of 2 years of pertinent Clinical Operations experience.

• At least 1 year of monitoring experience.

• Experience with global oncology trials is preferred.

• Proficient in Microsoft Word, Excel, PowerPoint, and Outlook.

• Knowledgeable about industry Clinical Trial Management Systems (CTMS) and data management systems.

• Comprehensive understanding of ICH guidelines and associated regulatory standards.

• Proficient in English, both written and spoken.

• Willingness to travel up to 70% of the time.

🏝️ Benefits

• Eligibility for an annual bonus plan for non-commercial roles.

• Access to an incentive compensation plan for commercial roles.

• Discretionary equity awards.

• Employee Stock Purchase Plan.

• Comprehensive medical insurance.

• Dental insurance coverage.

• Vision insurance options.

• 401(k) retirement plan.

• Flexible Spending Account (FSA) and Health Savings Account (HSA) options.

• Life insurance coverage.

• Paid Time Off (PTO).

• Wellness programs.