Clinical Research Associate II (CRA II) – Fortrea
Location
Bangalore, India
Job Type
Full-time
Experience Required
2–5 years of Clinical Monitoring experience in Clinical Research, CRO, or Pharmaceutical organizations.
Ability to independently monitor clinical study sites according to ICH-GCP guidelines and project requirements.
Estimated Salary Package (Market Standard)
₹9 – ₹15 LPA (approx.), depending on experience, therapeutic area expertise, and interview performance.
Job Overview
The Clinical Research Associate II (CRA II) is responsible for independently monitoring clinical trial sites to ensure compliance with study protocols, ICH-GCP guidelines, sponsor requirements, and regulatory standards. The role includes site management, monitoring visits, source data verification, regulatory documentation, investigational product accountability, and ensuring patient safety throughout the clinical trial lifecycle.
Key Responsibilities
Clinical Site Monitoring
Conduct Pre-Study, Site Initiation, Routine Monitoring, Interim, and Close-Out Visits.
Manage assigned clinical study sites according to SOPs, ICH-GCP guidelines, and sponsor requirements.
Prepare and implement monitoring plans.
Verify study training records and site readiness.
Ensure audit and inspection readiness at study sites.
Clinical Data & Compliance
Perform Source Data Verification (SDV) and source document review.
Review eCRFs and resolve clinical data queries.
Identify protocol deviations and ensure corrective actions are implemented.
Ensure data integrity, accuracy, completeness, and regulatory compliance.
Maintain current and accurate regulatory documentation in eTMF and sponsor systems.
Patient Safety & Study Conduct
Verify informed consent procedures before patient enrollment.
Ensure protocol compliance and subject eligibility.
Track Serious Adverse Events (SAEs) and follow up as required.
Monitor Investigational Product (IP) storage, inventory, and accountability.
Ensure study materials are stored according to protocol requirements.
Study Coordination
Support investigator recruitment and site management activities.
Track IP shipments and study supplies.
Maintain CTMS and other eClinical systems.
Prepare and submit timely monitoring and trip reports.
Attend investigator meetings, project meetings, and study teleconferences.
Present Site Initiation Visit (SIV) training when assigned.
Mentor or assist in training new Clinical Research Associates through co-monitoring.
Educational Qualification
Bachelor's degree in Life Sciences, Pharmacy, Nursing, Biotechnology, Medical Sciences, or a related healthcare discipline.
Nursing licensure or equivalent allied health qualification is also acceptable.
Equivalent relevant experience may be considered.
Required Skills
Strong understanding of ICH-GCP guidelines and local regulatory requirements.
Experience in independent clinical site monitoring.
Knowledge of clinical trial processes and monitoring procedures.
Experience with Source Data Verification (SDV) and eCRF review.
Familiarity with Serious Adverse Event (SAE) reporting.
Experience using CTMS and other eClinical systems.
Good analytical, problem-solving, and negotiation skills.
Strong organizational and planning abilities.
Excellent verbal and written English communication skills.
Proficiency in Microsoft Office applications.
Ability to work independently in a matrix environment.
Preferred Qualifications
Experience with Phase I clinical trials.
Prior experience in medical devices or clinical research laboratories.
Knowledge of ISO 14155 for medical device studies.
Additional experience in clinical operations, pharmacology, physiology, data management, or technical writing.
Familiarity with Fortrea SOPs for clinical monitoring.
Work Environment
Office, home-based, clinical research unit, and hospital environments.
Approximately 60% travel to clinical trial sites.
May require work outside normal office hours based on study needs.
Frequent use of computers and clinical trial management systems.
Who Should Apply
Clinical Research Associates (CRA I/II), Site Monitors, Clinical Trial Monitors, and Clinical Operations professionals with 2–5 years of monitoring experience.
Candidates seeking career growth in global Clinical Operations, site monitoring, and clinical trial management within CROs or pharmaceutical companies.
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