Job Type:
Full Time
Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences
Skills:
Causality Assessment, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding,
JOB DESCRIPTION
Organization: Fortrea
Position: Clinical Research Associate (CRA)
About Fortrea
Overview:
- Leading global contract research organization (CRO).
- Provides a wide range of clinical development, patient access, and technology solutions.
- Specializes in more than 20 therapeutic areas.
- Operates with over 19,000 staff in more than 90 countries.
- Committed to transforming drug and device development for partners and patients globally.
Website: Fortrea
Summary of Responsibilities
- Site Management: Manage clinical studies according to Fortrea’s SOPs, ICH GCP Guidelines, project plans, and Sponsor requirements.
- Site Monitoring: Conduct site monitoring for clinical trials, including Pre-study, Site Initiation, Process Monitoring, Routine Monitoring, and Close-out Visits.
- Project Planning: Prepare and implement project plans related to Clinical Monitoring responsibilities.
- Subject Protection: Verify adherence to informed consent procedures, protocol requirements, and regulatory requirements.
- Data Integrity: Review and verify source documents, generate and resolve queries, ensuring data integrity against established guidelines.
- Regulatory Compliance: Ensure Site Regulatory documents and eTMF/Sponsor Documents are complete and current.
- Investigational Product Management: Ensure accurate inventory and accountability of study materials, secure storage per protocol.
- Quality Control: Adhere to global quality control and CRA performance metrics.
- Audit Readiness: Ensure sites are audit-ready.
- Leadership: Act as Lead CRA as assigned.
Qualifications
Education:
- University or college degree, or certification in a related allied health profession (e.g., nursing licensure) from an accredited institution.
- Equivalent experience may be substituted as appropriate.
Knowledge:
- Thorough understanding of ICH GCP Guidelines and local regulatory requirements.
Experience
- Minimum of 2 years of Clinical Monitoring experience.
Fortrea’s Commitment
Fortrea seeks motivated problem-solvers and creative thinkers to revolutionize the clinical trial development process. We are dedicated to delivering life-changing ideas and therapies swiftly to patients in need. Join our team and embrace a collaborative environment that nurtures personal growth and enables a meaningful global impact.
Equal Opportunity Statement
Fortrea is an Equal Opportunity Employer (EOE/AA), striving for diversity and inclusion. We do not tolerate harassment or discrimination of any kind and make employment decisions based on business needs and individual qualifications without regard to:
- Race
- Religion
- Color
- National origin
- Gender (including pregnancy or other medical conditions/needs)
- Family or parental status
- Marital, civil union, or domestic partnership status
- Sexual orientation
- Gender identity
- Gender expression
- Personal appearance
- Age
- Veteran status
- Disability
- Genetic information
- Any other legally protected characteristic
Encouragement: We encourage all to apply.
For more information, visit Fortrea.
