Clinical Research Associate II

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

📋 Description

• Execute and coordinate designated components of the clinical monitoring process in line with GCPs and SOPs.

• Conduct site assessments to evaluate protocol and regulatory adherence and prepare necessary documentation.

• Build collaborative relationships with investigative sites and study vendors.

• Deliver training on the protocol and related studies to assigned clinical study sites.

• Attend disease indication, project-specific, regional investigator meetings, and site booster training as required.

• Monitor enrollment, CRF data entry, protocol deviation patterns, and overall site-related issues.

• Act as a mentor/trainer for less experienced CRAs.

• Communicate site performance metrics to the Clinical Study Team.

• Provide study-specific training to the project team.

• Conduct SAE reconciliation and address discrepancies with study sites.

• Collaborate with the CST and clinical study sites to achieve study milestones, including startup, recruitment, database analysis, and closeout.

• Assist with audit/inspection preparation and follow up on quality issues or findings until resolution.

• Offer site-level management for established protocols and portfolios.

• Co-monitor with CRAs and assist with site visits as necessary.

• Support other assigned clinical responsibilities.

⛳️ Requirements

• Bachelor's degree in a relevant scientific field.

• At least 2+ years of relevant Clinical Operations experience.

• A minimum of 1+ years of monitoring experience.

• Experience in global oncology trials is preferred.

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

• Familiarity with industry CTMS and data management systems.

• Comprehensive knowledge of ICH and associated regulatory guidelines.

• Outstanding communication and interpersonal skills.

• Excellent organizational abilities with a knack for prioritizing and multitasking.

• Proficient in English, both written and spoken.

• Willingness to travel up to 70%.

🏝️ Benefits

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

• Incentive compensation plan eligibility for commercial roles.

• Discretionary equity awards.

• Option to participate voluntarily in the Employee Stock Purchase Plan.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401(k) plan.

• FSA/HSA options.

• Life insurance coverage.

• Paid Time Off.

• Wellness programs.