FSP – Senior CRA / CRA II (Cardiology & Electrophysiology Device)
Category: Clinical
Job ID: 255405
Locations: Remote US (available in 13 locations)
Travel: 60–80% (nationwide travel)
Target Pay Range: $115,000 – $142,000
✅ Role Overview
Fortrea is hiring experienced Cardiology Device/Electrophysiology Senior CRAs (5+ years monitoring preferred; may consider 2+ years with strong device expertise). This role is part of the Functional Service Provider (FSP) team and involves advanced monitoring, site management, leadership responsibilities, and contribution to study operations.
You will independently oversee clinical sites, ensure high-quality data, maintain patient safety, and support project leadership tasks including mentoring, QC visits, feasibility, and protocol development.
✅ Key Responsibilities
1. Site Monitoring & Management
Conduct all monitoring activities including:
Pre-study visits
Site initiation visits
Routine monitoring
Close-out visits
Maintain essential documents and study files.
Perform efficient onsite monitoring in compliance with SOPs, guidelines, and cost policies.
Ensure audit readiness at all assigned sites.
2. Patient Safety & Regulatory Compliance
Verify study staff training and site readiness.
Ensure proper informed consent procedures.
Confirm adherence to protocol requirements and regulatory guidelines.
Protect subject safety and rights throughout the study.
3. Data Accuracy & Quality Oversight
Perform source data verification and CRF review.
Identify, document, and resolve missing or implausible data.
Track and manage Serious Adverse Events (SAEs), including reporting, narratives, and follow-up.
Prepare accurate and timely trip reports.
4. Project Leadership & Coordination
Lead monitoring for assigned protocols or projects.
Support creation/review of monitoring plans, trip reports, and study tools.
Assist in developing study protocols and Case Report Forms (CRFs).
Participate in clinical study report writing.
Conduct Quality Control (QC) visits as needed.
Manage small projects under a Project Manager/Director.
5. Stakeholder & Vendor Interaction
Liaise with vendors and external collaborators.
Act as local contact for clinical trial supplies and site communications.
Support investigator recruitment and feasibility assessments.
6. Regulatory & Administrative Support
Assist with ethics committee submissions and regulatory notifications.
Translate study documents as required.
Organize investigator meetings and presentations.
Negotiate study budgets with investigators.
Support agreements alongside Legal teams.
7. Training & Mentoring
Train, guide, and co-monitor junior CRAs.
Share best practices and support team development.
Assist with onboarding of new employees.
8. Other Responsibilities
Coordinate designated projects as a Local Project Coordinator.
Ensure proper registry management.
Perform additional duties as assigned by management.
✅ Qualifications
Education
Bachelor’s degree in life sciences preferred, or related allied health certification.
Nursing, medical technology, or laboratory technology backgrounds accepted.
OR: Minimum 3 years relevant clinical research experience (in lieu of degree).
Experience
Minimum 2 years of clinical monitoring experience (5+ years preferred).
Cardiology Device / Electrophysiology experience required.
Strong SAE processing knowledge (narratives, reporting, follow-up).
Advanced monitoring, site management, and registry administration skills.
Skills & Competencies
Strong planning, organizational, and time-management skills.
Advanced communication skills (written & verbal).
Proficiency with multiple computer systems and eClinical tools.
Ability to work independently with minimal supervision.
Ability to train/supervise junior staff.
Strong problem-solving and decision-making ability.
Valid Driver’s License required.
Preferred
Experience in medical/pharmaceutical/research/laboratory fields.
Project management or Local Project Coordinator experience.
✅ Work Environment
Setting
Remote / Home-office based.
Regular travel to clinical sites (domestic; occasional international).
Physical Requirements
Frequent stationary work (6–8 hours/day).
Repetitive hand and wrist movements (typing, data entry).
Occasional crouching, stooping, bending, twisting.
Lifting up to 15–20 lbs (luggage, laptop).
Ability to operate a vehicle safely.
Consistent and reliable attendance.
Flexible work hours depending on study needs.
Gujarat :
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Queensland |Melbourne :
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Canada |Quebec :
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Japan | Saitama |Tokyo :
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