Senior Clinical Research Associate

This is a fully remote position, open to applicants in South Korea.

📋 Description

• Conduct feasibility assessments for potential sites

• Execute pre-study, study initiation, and interim monitoring visits in accordance with protocol requirements

• Serve as Lead CRA for global studies and oversee CRAs

• Create Clinical Monitoring Plans as needed

• Review site visit trip reports and offer feedback and revisions

• Mentor and support junior CRAs and site personnel

• Develop study-specific tools and templates

• Engage in study team, investigator, and bid defense meetings

• Design and deliver training for study team members or colleagues

• Collaborate with Project Management to assess deliverables and study milestones

• Compile documentation for regulatory and ethical submissions

• Coordinate the shipment and receipt of study materials

• Document findings from site visits in written reports

• Contribute to protocol and CRF design

• Evaluate, monitor, and train study site staff on protocol compliance

• Review subject safety information and informed consent documents

• Perform source document verification for compliance, patient safety, and data integrity

• Review paper or electronic CRFs and assist in resolving data queries

• Support sites with the maintenance of the Investigator Site File

• Maintain consistent communication with sites

• Update site-related documentation for filing in the Trial Master File

• Ensure site adherence to investigational product receipt, accountability, and return or destruction

• Conduct accompanied site visits for assessing or training other CRAs

• Complete final site close-out visits and documentation

• Perform additional duties as assigned

⛳️ Requirements

• Medical Doctor (MD) degree or Pharmacist (MSPH, PharmD, PhD, or equivalent Pharmacy degree, etc.) with at least three years of experience as a Clinical Research Associate

• OR a minimum of a four-year college degree with a major in medical, biological, physical, health, pharmacy, or a related science and at least five years as a Clinical Research Associate

• OR a two-year college degree or equivalent education/training with a minimum of seven years as a Clinical Research Associate

• Willingness to travel is required

• A valid current passport is required

• A driving license is required

• Proficient in the local languages of the countries under responsibility and fluent in both spoken and written English

• Outstanding oral and written communication skills

• Strong planning and organizational abilities with effective time management

• Excellent interpersonal skills

• Proactive and equipped with problem-solving abilities

• Capability to lead and inspire the assigned team, if applicable

• Comprehensive understanding of clinical research principles and processes

• In-depth knowledge of FDA and/or EU directives and regulations, ICH guidelines, and local regulatory requirements

• Thorough familiarity with two to three therapeutic areas

• Strong understanding of standard operating procedures

• Proficient in Microsoft Office

• Experienced with IxRS and EDC systems

🏝️ Benefits

• Equal employment opportunities irrespective 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 any other class protected by applicable law