In-House Clinical Research Associate II
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Job Description
In-house Clinical Research Associate supporting site management and data-quality activities for Worldwide Clinical Trials, a global contract research organization. Coordinating clinical-study documentation, monitoring support, queries, recruitment, and site communications.
Responsibilities:
- Perform site management tasks for clinical studies according to GCPs, regulations, and SOPs
- Support Clinical Trial Managers and field Clinical Research Associates
- Assist with site feasibility questionnaires and CDA collection
- Coordinate shipment and receipt of study materials
- Update and review site documentation for Trial Master File submission
- Support Investigator Site File maintenance, TMF reconciliation, and quality-control checklists
- Conduct pre-study, initiation, interim, remote monitoring, and close-out visits under guidance
- Maintain communication with clinical study sites
- Review EDC case report forms for completion, logic checks, and data-entry compliance
- Assist sites with EDC and vendor query resolution
- Generate portal and EDC reports and maintain study trackers
- Prepare field CRA visit materials and summarize action items, protocol deviations, queries, supplies, and training
- Support site staff changes, essential-document collection, regulatory documents, training, and task delegation
- Manage vendor system access for site staff
- Support prescreening, screening, and recruitment
- Track subject eligibility reviews and support the Medical Monitor
Requirements:
- Good oral and written communication skills
- Good planning, organizational, interpersonal, and time-management skills
- Ability to work in an organized and methodical manner
- Basic understanding of clinical research principles and processes
- Understanding of FDA and/or EU regulations, ICH Guidelines, and local regulatory requirements
- Understanding of standard operating procedures
- Basic knowledge of Microsoft Office
- Familiarity with IVRS and eCRF systems
- Two-year college curriculum or equivalent education/training and one year of clinical research or relevant experience
- Alternatively, relevant education/training and a minimum of two years of clinical research experience may be considered
- Fluent in local languages of countries under responsibility
- Proficient in spoken and written English
Benefits:
- Diverse and inclusive work environment
- Supportive and cohesive teams
- Accessible leadership
- Equal employment opportunities
- Exceptional employee experiences
- Professional growth and opportunity to succeed
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