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

Position Overview

We are seeking skilled Clinical Research Associates (CRAs) and Senior CRAs with expertise in radiopharmaceutical therapies to join our Full Service Outsourcing team. This role supports various sponsors, requiring at least one year of independent clinical monitoring experience with a CRO or sponsor. The position offers remote work within major US hub locations and necessitates approximately 60-70% travel, with 8-10 days on-site visits monthly.

Key Responsibilities

• Oversee all facets of clinical study site monitoring, including routine and close-out visits, management of study documentation, and conducting pre-study and initiation visits.
• Collaborate with vendors and perform other designated duties as assigned within project management plans.
• Manage clinical sites ensuring compliance with study protocols, regulations, and participant safety.
• Verify study staff receive proper training and materials to safely enroll patients as per protocol standards.
• Ensure adherence to informed consent procedures and regulatory requirements to protect study participants.
• Review and validate data quality and integrity on Case Report Forms (CRFs) and other data collection tools by monitoring source documents.
• Manage registry activities and undertake feasibility assessments when requested.
• Report and manage Serious Adverse Events (SAEs) including documentation, narrative preparation, and follow-up.
• Independently review CRFs, handle query generation and resolution using data management systems.
• Support training of new staff through co-monitoring activities.
• Coordinate clinical projects locally as a Local Project Coordinator and serve as a local client liaison when assigned.

Qualifications and Experience

• A university or college degree, or certification in a related allied health field (such as nursing licensure) from an accredited institution.
• Minimum of one year of experience in clinical monitoring roles.
• Experience with radiopharmaceuticals is preferred.
• Flexibility to work from various US hub locations.

Work Environment and Expectations

• A fast-paced setting that demands strict compliance with study protocols and adherence to critical timelines.
• Constantly shifting priorities requiring rapid adaptation and prioritization.
• Strong emphasis on teamwork and interpersonal skills to ensure effective study execution.
• Use of technology to collect data electronically within the clinical trial process.
• Work typically performed in an office environment, using electrical office equipment.
• Frequent domestic and occasional international travel to client and site locations.
• Physical activities include extended sitting, driving, repetitive hand movements, bending, lifting objects up to 15-20 lbs, and consistent attendance is required.
• Variable working hours may occasionally be needed.
• This is a remote position with travel as outlined.

Compensation and Benefits

• Target salary range for this role is between $105,000 and $145,000 annually, commensurate with title.
• Comprehensive benefits available for employees working 20 or more hours per week, including medical, dental, vision insurance, life and disability coverage with multiple carrier options.
• 401(k) retirement plan.
• Paid time off (PTO) under a flexible plan.
• Employee recognition programs and multiple employee resource groups (ERGs).

Additional Information

Applications are accepted continuously. The employer promotes equal employment opportunity and provides accommodations upon request.