Clinical Research Associate & Senior Clinical Research Associate - Radiopharmaceutical Therapies (Remote US)

About the Role

We are seeking experienced Clinical Research Associates (CRAs) with expertise in Radiopharmaceutical therapies to join our Full Service Outsourcing team. This position involves collaborating with diverse sponsors across the US with significant travel requirements. Candidates must have at least one year of independent monitoring experience within a CRO or sponsor setting. The role expects 60-70% travel, approximately 8-10 days on-site per month, and openness to various major US hub locations.

Key Responsibilities

• Manage all facets of study site monitoring including routine visits, close-out procedures, maintaining study documentation, pre-study and initiation visits, and vendor coordination.
• Oversee site management tasks as outlined in project plans.
• Conduct on-site monitoring visits ensuring adherence to protocols.
• Confirm study personnel have received the necessary materials and training to safely enroll patients into trials.
• Ensure patient protection by verifying compliance with informed consent and protocol guidelines per regulatory standards.
• Maintain data integrity by reviewing case report forms and other data collection tools, monitoring for missing or inconsistent data.
• Take charge of registry management responsibilities as assigned in project plans and assist with feasibility assessments when requested.
• Complete Serious Adverse Event (SAE) reporting including report preparation, narrative creation, and follow-up activities.
• Perform independent case report form review, issue query generation and resolution following data review policies on designated data systems.
• Support training initiatives for new personnel through activities such as co-monitoring.
• Coordinate local clinical projects as Local Project Coordinator under supervision and serve as a local client liaison if designated.
• Carry out additional duties assigned by management.

Candidate Requirements

• Possession of a university or college degree or certification in a related allied health discipline from an accredited institution (such as nursing licensure).
• Minimum one year of clinical monitoring experience.
• Experience working with radiopharmaceuticals is preferred.
• Willingness to operate from various US hub locations.
• Ability to thrive in a dynamic, fast-paced environment with zero tolerance for protocol deviations and strict timeline adherence.
• Adaptability to shifting priorities and demands on short notice.
• Strong teamwork and interpersonal skills necessary to ensure smooth study operations.
• Comfortable working within technology-driven environments, utilizing electronic data capture tools directly.

Benefits and Work Environment

• Comprehensive benefits package available for full-time or part-time employees working 20+ hours/week, including medical, dental, vision, life, and short/long-term disability insurance across multiple providers.
• 401(k) retirement plan enrollment.
• Paid time off with a flexible PTO plan.
• Employee recognition programs and multiple employee resource groups.
• Target salary range is $105,000 to $145,000 annually depending on title.
• Work typically performed in an office environment with regular exposure to standard office technology.
• Frequent travel to client and site locations is required, including domestic and occasional international trips.

Physical and Work Requirements

• Ability to remain seated for extended durations and operate a vehicle safely.
• Manual dexterity involving repetitive hand motions.
• Occasional bending, crouching, and twisting movements of upper body and neck.
• Competence using a variety of in-house and commercial software applications.
• Capability to lift and carry objects weighing up to 15-20 lbs, such as luggage and laptops.
• Consistent attendance and willingness to work varying hours as needed.

Additional Information

This is a remote position with applications accepted continuously. Our company is an equal opportunity employer that supports accommodations upon request.