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Sr. Cra Ii, Oncology, Fsp - Midwest

Fortrea
Fortrea
5+ years
$125 - $140K
Indianapolis, kentucky, OH, United States
10 April 22, 2026
Job Description
Job Type: Full Time Remote Education: B.Pharm. or Post-Graduation (Microbiology/Quality Assurance/Biochemistry/Biotechnology) 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

Job Title:

Senior Clinical Research Associate II (Oncology)


Team:

FSP (Functional Service Provider)


Location:

Midwest, USA (Preferred: Louisville, Cincinnati, Indianapolis)


Experience Required:

  • 5+ years of clinical monitoring experience
  • Oncology experience (early phase preferred)

Job Overview:

The Sr. CRA II is responsible for end-to-end site monitoring and management of clinical trials, ensuring protocol compliance, data integrity, and patient safety. This role involves frequent travel, stakeholder coordination, and independent oversight of study sites.


Key Responsibilities:

Site Monitoring & Management:

  • Conduct:
    • Pre-study visits
    • Site initiation visits
    • Routine monitoring visits
    • Close-out visits
  • Maintain study files and documentation
  • Manage site activities as per project plans
  • Liaise with vendors and stakeholders

Patient Safety & Compliance:

  • Ensure informed consent procedures are properly followed
  • Verify adherence to protocol and regulatory requirements
  • Safeguard participant safety throughout the study

Data Review & Quality Assurance:

  • Review Case Report Forms (CRFs) and source documents
  • Identify and resolve data discrepancies and queries
  • Monitor for missing or inconsistent data
  • Ensure high standards of data integrity

Safety Reporting:

  • Manage and report Serious Adverse Events (SAEs)
  • Prepare narratives and follow-up reports
  • Ensure timely submission as per guidelines

Project Coordination & Support:

  • Support registry management and feasibility assessments
  • Act as Local Project Coordinator when required
  • Serve as a local client contact (if assigned)
  • Assist in training new team members (e.g., co-monitoring)

Additional Responsibilities:

  • Perform CRF reviews and query resolution independently
  • Coordinate with data management systems (Fortrea/client)
  • Complete additional tasks as assigned by management

Qualifications (Minimum Required):

  • University/college degree OR
  • Certification in allied health profession (e.g., nursing)

Skills & Competencies:

  • Strong knowledge of clinical trial monitoring
  • Excellent attention to detail and problem-solving ability
  • Strong communication and interpersonal skills
  • Ability to manage multiple priorities in a fast-paced environment
  • Familiarity with electronic data capture systems

Work Environment:

  • Office-based work with frequent travel to clinical sites
  • Domestic and occasional international travel

Travel Requirements:

  • 40–50% overnight travel required

Work Style Expectations:

  • Fast-paced, protocol-driven environment
  • High accountability for timelines and compliance
  • Requires adaptability to changing priorities
  • Strong teamwork and collaboration required
  • Technology-driven workflows

Physical Requirements:

  • Ability to sit for extended periods and operate a vehicle
  • Repetitive hand and wrist movements (computer use)
  • Occasional bending, stooping, and twisting
  • Ability to lift 15–20 lbs (e.g., laptop, luggage)
  • Regular and consistent attendance required
  • Flexible working hours as needed

Compensation:

  • Target Salary Range: $125,000 – $140,000