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

Overview

We are actively seeking skilled Clinical Research Associates and Senior CRAs with a focus on radiopharmaceutical therapies to join our Full Service Outsourcing team. This role involves collaborating with a variety of sponsors and requires independent clinical research monitoring experience. The position offers remote work with travel requirements of 60-70%, typically 8-10 days onsite per month, and candidates can be based near major US hubs.

Key Responsibilities

• Manage all phases of study site monitoring including routine visits, site close-outs, pre-study and initiation visits, and maintenance of study documentation.
• Oversee site management activities according to project plans, ensuring adherence to monitoring protocols.
• Conduct comprehensive on-site monitoring visits and ensure clinical teams are properly trained and equipped for protocol compliance and patient safety.
• Verify informed consent procedures and protocol compliance to protect study participants, aligning with regulatory standards.
• Ensure the accuracy and integrity of collected clinical data by thorough source document verification and CRF review to identify missing or irregular data.
• Perform registry management responsibilities and feasibility assessments as assigned.
• Handle Serious Adverse Event (SAE) reporting, including narrative documentation, follow-up, and reporting processes.
• Independently review case report forms, generate queries, and resolve data discrepancies using Fortrea or client data management systems.
• Support training efforts for new staff through co-monitoring and knowledge sharing.
• Serve as a Local Project Coordinator managing designated clinical projects and may act as a local client liaison when directed.
• Carry out additional tasks as delegated by management.

Qualifications

• Degree from a university or college in a related allied health discipline, or equivalent certification such as a nursing license from an accredited institution.
• Minimum of 1 year of experience in clinical monitoring within CRO or sponsor settings.
• Experience in radiopharmaceutical clinical studies is preferred.
• Flexibility to be based in various major hub locations across the United States.

Work Environment & Expectations

• Fast-paced setting requiring strict adherence to study protocols and timelines.
• Constantly shifting priorities demanding agility and effective prioritization skills.
• Strong emphasis on teamwork and interpersonal skills to facilitate smooth operations.
• Data collection is primarily through electronic systems, necessitating comfort with technology.

Physical and Other Requirements

• Extended periods of sitting and ability to safely operate a vehicle.
• Frequent hand movements including fast, repetitive finger and wrist actions.
• Occasional physical maneuvers such as crouching, stooping, bending, and twisting.
• Capability to handle light to moderate lifting up to 15-20 pounds including luggage and laptops.
• Proficiency in computer software, both proprietary and commercial.
• Regular attendance and flexibility for variable working hours.

Compensation and Benefits

• Annual salary target ranges from $105,000 to $145,000 depending on role and experience.
• Full-time or part-time employees working 20+ hours per week are eligible for comprehensive benefits including medical, dental, vision insurance, life and disability coverage.
• 401(k) retirement plan.
• Generous paid time off with flexible plans.
• Employee recognition programs and multiple employee resource groups.

Additional Information

• Work primarily performed remotely with frequent domestic and some international travel to clinical sites.
• Workplace exposure includes standard office environments with electrical equipment.
• Applications are accepted continuously on an ongoing basis.
• Diversity and accommodation policies are in place to support equal employment opportunity.