FSP - Sr. CRA - Oncology - Florida

Role Summary

Senior Clinical Research Associate (Oncology) based in Florida, joining Fortrea's FSP team. The Senior CRA is responsible for site monitoring and site management for oncology studies in accordance with Fortrea and Sponsor SOPs and regulatory guidelines. They will ensure the implementation of project plans, lead projects of limited scope, and may assume line management responsibilities or serve as Local Project Coordinator or Lead CRA as assigned.

Responsibilities

• Develop and execute monitoring plans; conduct routine monitoring and closeout visits; maintain study files; perform pre-study and initiation visits; liaise with vendors; and other duties as assigned.
• Oversee all aspects of site management as prescribed in the project plans.
• Direct general on-site monitoring activities to ensure staff have the materials and instructions to safely enroll patients into the study.
• Protect study patients by ensuring informed consent procedures and protocol requirements comply with applicable regulatory requirements.
• Verify data integrity through source data review and monitor data for missing or implausible entries.
• Manage resources efficiently in line with SOPs and travel policies, including economical travel.
• Maintain audit readiness at the site level.
• Travel (including air travel) may be required and is an essential function of the role.
• Prepare accurate and timely trip reports; manage small projects under supervision; serve as lead monitor for protocols or projects as assigned.
• Review project progress, initiate actions to meet objectives, and organize Investigator Meetings.
• Contribute to protocol and Case Report Form development; participate in writing clinical trial reports.
• Collaborate with internal teams to assess needs, resources, and timelines; act as contact for clinical trial supplies and vendors.
• Lead registry management efforts as prescribed in project plans; conduct feasibility studies when requested; perform QC visits when required.
• Recruit investigators, prepare regulatory submissions, translate study documentation, and coordinate meetings as directed.
• Negotiate study budgets with investigators and support the legal department with related agreements.
• Monitor, report, and follow up on Serious Adverse Event (SAE) reporting and related narratives.
• Perform CRF reviews, generate and resolve data queries as assigned; provide training and mentoring to new staff; coordinate projects as Local Project Coordinator if applicable; perform other duties as assigned.

Qualifications

• Required: University or college degree (life science preferred) or certification in a related allied health profession from an accredited institution, nursing certification, medical or laboratory technology.
• Required: Alternatively, minimum 3 years of relevant clinical research experience in pharmaceutical or CRO industries.
• Required: Thorough knowledge of regulatory requirements including international considerations.
• Required: Thorough understanding of the drug development process.
• Required: Fluent in the local office language and in English, both written and verbal.
• Required: Valid Driver's License.
• Experience: Three (3) years of clinical monitoring experience.
• Experience: Understanding SAE reporting and follow-up processes.
• Experience: Advanced site monitoring, site management, and registry administration skills.
• Experience: Ability to work with minimal supervision and strong planning, organization, and computer skills.
• Experience: Advanced verbal and written communication skills; ability to train and supervise junior staff; ability to work in a matrix/project team environment.
• Preferred: One (1) or more years of additional experience in a related field.
• Preferred: Local project coordination and/or project management experience.

Education

• University or college degree (life science preferred), or certification in a related allied health profession from an accredited institution; nursing certification; medical or laboratory technology.

Skills

• Advanced verbal and written communication skills.
• Ability to train and supervise junior staff.
• Ability to work effectively within a project team and matrix environment.
• Strong planning, organization, and computer skills.

Additional Requirements

• Travel requirements: 60-80% overnight.
• Work environment: office-based with occasional site visits; domestic and international travel.
• Physical demands: frequently stationary for 6-8 hours; repetitive hand movements; occasional crouching/stooping with bending and twisting; ability to lift up to 15-20 lbs; regular attendance; varied hours.