Senior CRA, FSP - Cardiac / Medical Device

This is a fully remote position, open to applicants in California, +3 more states.

📋 Description

• Execute all facets of study site monitoring, encompassing routine monitoring and closeout activities at clinical sites.

• Maintain study documentation and carry out pre-study and initiation visits.

• Collaborate with vendors and oversee site management activities in alignment with project plans.

• Ensure that study personnel are equipped with appropriate materials and instructions for the safe enrollment of patients in the study.

• Confirm informed consent procedures and protocol requirements to safeguard study participants.

• Review source documents and monitor CRFs and other data collection instruments for data integrity.

• Identify missing or implausible data and ensure audit readiness at the site level.

• Prepare precise and timely trip reports.

• Manage small-scale projects under the guidance of a Project Manager/Director.

• Act as the lead monitor for a specific protocol or project, assisting with monitoring plans and the review of trip reports.

• Assess project progress and initiate steps to meet target objectives.

• Organize and present at Investigator Meetings.

• Contribute to the development of protocols, Case Report Forms, and clinical trial reports.

• Engage with internal work groups to assess needs, resources, and timelines.

• Serve as the point of contact for clinical trial supplies and other vendors.

• Manage clinical trial registries and conduct feasibility assessments.

• Carry out, report, and follow up on Quality Control visits.

• Recruit potential investigators and prepare EC submissions and regulatory notifications.

• Translate study-related documentation and organize assigned meetings.

• Negotiate study budgets and assist Fortrea legal with agreements.

• Track and follow up on Serious Adverse Event reporting, generating related reports and narratives.

• Conduct CRF reviews, generate queries, and resolve queries in data management systems.

• Assist in training, mentoring, and the development of new staff members.

• Coordinate assigned clinical projects as a Local Project Coordinator and act as a local client contact when designated.

• Perform additional duties as assigned by management.

⛳️ Requirements

• Based in Central or West Coast.

• Experience in complex cardiac cases within the last 5 years, preferably in electrophysiology and/or devices.

• A minimum of 3 years of clinical monitoring experience.

• A university or college degree in life sciences is preferred, or certification in a related allied health profession from an accredited institution, nursing certification, or medical/laboratory technology.

• Relevant and equivalent experience may be accepted in lieu of educational qualifications.

• Comprehensive knowledge of regulatory requirements, including a basic understanding of regulations in other countries.

• In-depth understanding of the drug development process.

• Proficiency in the local office language as well as English, both written and spoken.

• Complete understanding of Serious Adverse Event reporting, including report generation, narratives, and SAE follow-up.

• Advanced skills in site monitoring.

• Advanced capabilities in study site management.

• Advanced proficiency in registry administration.

• Ability to work independently with minimal supervision.

• Strong planning and organizational skills.

• Proficient computer skills and familiarity with a variety of software applications.

• Exceptional verbal and written communication skills.

• Capability to train and supervise junior personnel.

• Aptitude for resolving project-related challenges and prioritizing workload for oneself and the team.

• Ability to work effectively within a project team and matrix environment.

• Valid Driver's License required.

• Willingness to travel overnight 60–80% of the time.

• Capacity to travel both domestically and internationally.

• Ability to remain stationary for 6–8 hours a day.

• Capability to perform repetitive hand movements.

• Ability to crouch, stoop, bend, and twist.

• Ability to lift and transport luggage and a laptop weighing 15–20 lbs.

• Regular and consistent attendance is essential; varied hours may be required.

🏝️ Benefits

• Target Pay Range: $130-133K.

• Office/Home-Based work environment.

• Fortrea travel policy for economical travel expenses.