Clinical Research Associate – Sponsor Dedicated

This is a fully remote position, open to applicants in Colorado, +1 more state.

📋 Description

• Conduct site qualification, initiation, interim monitoring, management, and close-out visits either on-site or remotely.

• Assess the performance of sites and site staff, recommending actions tailored to specific sites.

• Address significant issues promptly and formulate action plans accordingly.

• Confirm adherence to informed consent protocols, ensuring subject safety, confidentiality, compliance with protocols, and integrity of clinical data.

• Evaluate site processes and perform source document reviews.

• Validate clinical data recorded in case report forms and address any queries.

• Ensure compliance with electronic data capture procedures.

• Oversee the inventory, reconciliation, storage, dispensing, and administration of investigational products as necessary.

• Review Investigator Site Files, ensuring they align with Trial Master Files.

• Draft confirmation letters, follow-up correspondence, trip reports, communication logs, and project documentation.

• Assist in strategies for subject/patient recruitment, retention, and awareness.

• Monitor observations, site status, and action items throughout the project.

• Manage site-level activities and communications to achieve project goals, deliverables, budgets, and timelines.

• Serve as a liaison with study site personnel and collaborate with Central Monitoring Associates.

• Provide training to assigned sites and project-specific team members.

• Participate in investigator, sponsor, clinical monitoring, project staff, and clinical training meetings.

• Support audit readiness and follow-up actions following audits.

• For Real World Late Phase: assist sites throughout the study lifecycle, perform chart abstraction and data collection, collaborate with sponsor affiliates, medical science liaisons, and local country staff, train junior staff, identify activities outside the project scope, and propose potential sites.

⛳️ Requirements

• Bachelor’s degree or RN in a relevant field, or an equivalent combination of education, training, and experience.

• Understanding of Good Clinical Practice/ICH Guidelines and other relevant regulatory standards.

• Proficient computer skills and a willingness to adopt new technologies.

• Strong communication, presentation, and interpersonal abilities.

• Capability to manage travel requirements of up to 75% regularly.

• Must adhere to site requests for medical and other personal information as necessary for facility access in the US.

• Familiarity with company SOPs and processes.

• For Real World Late Phase: awareness of local requirements pertaining to real world late phase study designs.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical skills and therapeutic areas.

• Peer recognition and a comprehensive total rewards program.

• Company-provided car or car allowance.

• Medical, dental, and vision health benefits.

• Company-matched 401(k) plan.

• Potential to earn commissions/bonuses based on both company and individual performance.

• Flexible paid time off (PTO) policy.

• Sick leave benefits.