Clinical Research Associate II/Sr. Clinical Research Associate

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

📋 Description

• Ensure the proper execution of clinical trials in alignment with the Study Monitoring Plan (SMP), applicable laws, Good Clinical Practice (GCP), and the standards set by the Sponsor.

• Oversee operational elements of clinical trial activities at designated investigator sites from site activation until database lock.

• Act as the main point of contact for the assigned investigator sites.

• Facilitate communication among study team members, vendors, and investigator sites.

• Conduct development, coaching, and training for site personnel.

• Provide training on the protocol and respond to protocol-related inquiries.

• Assist with investigator meetings, participant enrollment, site activation, recruitment efforts, and resolving recruitment challenges.

• Carry out onsite and remote/electronic monitoring for site initiation, routine monitoring, and site closure.

• Monitor adverse events and severe adverse events in collaboration with the Drug Safety Unit.

• Prepare and submit necessary reports, documents, updates, and tracking, including TMF documentation, site reports, protocol deviations, recruitment data, clinical supply management, study progress, and metrics.

• Identify and address issues at investigator sites and formulate corrective and preventative measures.

• Resolve data queries and perform close-out activities for investigator sites.

• Supervise the receipt, handling, accounting, storage, and disposal of investigational products.

• Provide support for database release as required.

• Maintain a solid understanding of the product, protocol, and therapeutic area.

• Ensure patient safety and eligibility, and offer clinical guidance to investigators.

• Lead Quality Event remediation and audit Corrective and Preventative Action (CAPA) activities as necessary.

⛳️ Requirements

• In-depth knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) regulations, and local country laws.

• At least 2 years of relevant experience in clinical research site monitoring.

• Proficiency in English and fluency in the native language(s) of the country of work.

• Willingness to travel 60-80% of the time.

• A valid driver’s license and passport are required.

• Bachelor’s degree in life sciences or a professional degree in life sciences such as nursing, pharmacy, medical background, or an equivalent qualification.

🏝️ Benefits

• Equal opportunity employment without regard to legally protected status.

• Consideration for employment irrespective of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.