Fsp - Sr. Cra - Oncology - Florida

3+ years

$120,000 – $133,000

Remote

10 Oct. 7, 2025

Job Description

Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

FSP – Senior Clinical Research Associate (CRA) – Oncology

📍 Location: Florida (Available in 2 locations)
📂 Category: Clinical
🆔 Job ID: 255046
💼 Type: Full-Time, Field-Based (Travel Required)

About the Role

We are seeking experienced Oncology Clinical Research Associates (CRAs) residing in Florida to join our Functional Service Provider (FSP) team.

The Senior CRA I is responsible for site monitoring, site management, and clinical oversight in accordance with Fortrea and/or Sponsor SOPs, ICH-GCP, and regulatory guidelines. This position may also include project leadership, local coordination, and mentorship responsibilities.

You’ll play a key role in ensuring the quality, integrity, and compliance of oncology clinical trials across multiple sites.

Key Responsibilities

🧭 Core Monitoring & Site Management

Conduct pre-study, initiation, routine monitoring, and closeout visits per project plans.
Maintain study files and liaise with vendors as assigned.
Ensure site personnel are adequately trained and equipped to execute study protocols.
Verify informed consent procedures and patient safety compliance per regulatory standards.
Ensure source data verification (SDV) accuracy and CRF/data integrity.
Monitor missing, inconsistent, or implausible data and follow-up for resolution.
Maintain audit readiness and support inspection activities at site level.
Prepare accurate and timely trip reports.

📋 Project Leadership & Coordination

Serve as Lead CRA or Local Project Coordinator (LPC) for assigned protocols.
Assist in establishing monitoring plans, reviewing trip reports, and tracking project progress.
Manage small-scale projects under direction of a Project Manager/Director.
Coordinate local feasibility studies and investigator recruitment as needed.
Contribute to protocol development, CRF design, and clinical trial reports.
Represent Fortrea at Investigator Meetings, presenting project-related information.

🧩 Quality & Compliance

Ensure efficient use of Sponsor/Fortrea resources by adhering to SOPs and travel guidelines.
Conduct Quality Control (QC) visits and prepare corresponding reports.
Track and follow-up on Serious Adverse Events (SAEs), including narrative preparation and regulatory reporting.
Support regulatory submissions, budget negotiations, and contract documentation as assigned.

👥 Mentorship & Collaboration

Mentor and train junior CRAs via co-monitoring or coaching sessions.
Collaborate with cross-functional teams to align on project needs, resources, and timelines.
Communicate effectively with investigators, site staff, and internal departments.

Qualifications

🎓 Education

Bachelor’s degree in Life Sciences or related field (preferred).
Certification in a health-related discipline (nursing, medical, laboratory technology) may be accepted.
In lieu of education, 3+ years of relevant clinical research experience in pharmaceutical or CRO industries will be considered.

💼 Experience

Minimum 3 years of Clinical Monitoring experience (Oncology preferred).
Thorough knowledge of ICH-GCP, FDA/EU regulations, and drug development process.
Proven ability in:
- Site monitoring & management
- SAE reporting & narrative preparation
- Registry administration
- Project coordination & leadership

💻 Technical & Soft Skills

Strong planning, organization, and prioritization abilities.
Advanced proficiency in MS Office Suite and electronic data capture (EDC) systems.
Excellent written and verbal communication skills (English required).
Capable of training, mentoring, and supervising junior staff.
Effective in matrixed, cross-functional environments.
Valid Driver’s License required.

⭐ Preferred

≥1 additional year in medical, pharmaceutical, laboratory, or research roles.
Prior local project coordination or project management experience.

Work Environment & Travel

🧭 Travel Requirement: 60–80% (Domestic & International)
🏠 Work Setting: Office/Home-based (Field Monitoring)
✈️ Frequent air travel to clinical sites required.

Physical Requirements

Frequently stationary (6–8 hrs/day)
Regular hand movements (typing, data entry)
Occasional bending, twisting, crouching
Ability to lift/carry up to 15–20 lbs (luggage, laptop)
Consistent attendance and flexibility for varied hours

Compensation

💰 Target Pay Range: $120,000 – $133,000 (based on title & experience)

Why Join Fortrea?

Work on cutting-edge oncology trials impacting global patient outcomes.
Gain exposure to multi-sponsor, multi-phase clinical research projects.
Grow within a global CRO offering career development and leadership pathways.
Collaborative, EEO-compliant workplace with diverse opportunities.

🔗 Learn more: [EEO & Accommodations Request Information] (Insert official link if available)

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Fsp - Sr. Cra - Oncology - Florida

Job Description

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