Senior Clinical Research Associate
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Job Description
Senior Clinical Research Associate overseeing site qualification, monitoring, compliance, and close-out activities. Supporting Worldwide Clinical Trials’ global CRO studies in South Korea.
Responsibilities:
- Perform feasibility studies for potential sites
- Conduct pre-study, study initiation, interim monitoring, and site close-out visits in accordance with protocols, GCPs, regulations, and SOPs
- Function as Lead CRA for global studies and coordinate CRAs
- Develop Clinical Monitoring Plans
- Review site visit trip reports and provide feedback and edits
- Mentor and guide less experienced CRAs and site staff
- Design study-specific tools and templates
- Participate in study team, investigator, and bid defense meetings
- Create and conduct training for study team members or colleagues
- Work with Project Management to evaluate deliverables and study milestones
- Compile regulatory and ethical submission documentation
- Coordinate shipment and receipt of study materials
- Document site visit findings through written reports
- Provide input into protocol and CRF design
- Assess, monitor, and train site staff on protocol adherence
- Review subject safety information and informed consent
- Conduct source document verification
- Review paper or electronic CRFs and assist with data query resolution
- Assist sites in maintaining Investigator Site Files
- Maintain regular communication with study sites
- Update site-related documentation for filing in the Trial Master File
- Ensure site compliance with investigational product receipt, accountability, and return or destruction
- Conduct accompanied site visits for CRA assessment or training
- Complete final site close-out visits and reports
- Perform other duties as assigned
Requirements:
- Medical Doctor (MD) degree or Pharmacist (MSPH, PharmD, PhD, or equivalent Pharmacy degree, etc.) and a minimum of three years as a Clinical Research Associate
- A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science and a minimum of five years as a Clinical Research Associate
- Two-year college curriculum or equivalent education/training and a minimum of seven years as a Clinical Research Associate
- Willingness to travel required
- Valid current passport required
- Driving license required
- Fluent in the local languages of the countries under responsibilities
- Proficient in both spoken and written English
- Extensive understanding of clinical research principles and processes
- Thorough understanding of FDA and/or EU Directives and regulations, ICH Guidelines and local regulatory requirements
- Thorough understanding of two to three therapeutic areas
- Thorough understanding of standard operating procedures
- Proficiency in Microsoft Office
- Proficiency with IxRS and EDC systems
- Excellent oral and written communication skills
- Excellent planning, organizational and time management skills
- Excellent interpersonal, initiative, and problem-solving skills
Benefits:
- Equal employment opportunities regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law
- Supportive and inclusive workplace environment
- Collaboration and creativity-focused culture
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