Senior Clinical Research Associate

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

📋 Description

• Execute and coordinate designated components of the clinical monitoring process in alignment with GCPs and SOPs to evaluate the safety and effectiveness of investigational products and/or medical devices.

• Conduct site visits to assess compliance with protocols and regulations, and prepare necessary documentation.

• Build collaborative relationships with investigative sites and study vendors.

• Monitor enrollment status reports to ensure that study sites remain on track to achieve enrollment objectives.

• Act as a mentor/trainer for less experienced Clinical Research Associates (CRAs) to aid in general and study-specific monitoring challenges.

• Provide direct assistance to the Clinical Study Manager by helping with the review of monitoring visit reports and other managerial responsibilities as required.

• Carry out Serious Adverse Event (SAE) reconciliation and collaborate with study sites and CRAs to address discrepancies.

• Collaborate with the Clinical Study Team (CST) and clinical study sites to ensure the timely achievement of study milestones.

⛳️ Requirements

• A minimum of 4-6 years of pertinent Clinical Operations experience.

• At least 3-4 years of monitoring experience as a Clinical Research Associate (CRA) within the pharmaceutical or CRO industry.

• Exceptional communication and interpersonal skills.

• Strong organizational abilities with the capacity to prioritize tasks and manage multiple responsibilities effectively.

🏝️ Benefits

• Medical

• Dental

• Vision

• 401(k)

• FSA/HSA

• Life Insurance

• Paid Time Off

• Wellness