Senior Clinical Research Associate

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

📋 Description

• Conduct feasibility assessments for potential study sites.

• Perform pre-study, study initiation, and interim monitoring visits in compliance with protocol standards.

• Serve as Lead CRA for global studies and oversee the work of CRAs.

• Create Clinical Monitoring Plans as needed.

• Evaluate site visit trip reports and provide constructive feedback and revisions.

• Mentor and support less experienced CRAs and site personnel.

• Develop study-specific tools and templates.

• Attend study team, investigator, and bid defense meetings.

• Design and deliver training sessions for study team members or colleagues.

• Collaborate with Project Management to assess deliverables and study milestones.

• Compile necessary documentation for regulatory and ethical submissions.

• Coordinate the shipment and receipt of study materials at sites.

• Document findings from site visits through written reports.

• Contribute to the development of protocols and CRFs.

• Evaluate, monitor, and train site staff on adherence to protocols.

• Review subject safety data and informed consent processes.

• Conduct source document verification to ensure compliance, patient safety, and data integrity.

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

• Support the maintenance of the Investigator Site File.

• Maintain consistent communication with study sites.

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

• Ensure sites comply with investigational product receipt, accountability, and proper return or disposal.

• Conduct accompanied site visits for CRA evaluation or training purposes.

• Complete the final site close-out visit and report.

• Execute other assigned responsibilities.

⛳️ Requirements

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

• At least a four-year college degree focusing on medical, biological, physical, health, pharmacy, or related sciences, along with a minimum of five years as a Clinical Research Associate.

• Completion of a two-year college curriculum or equivalent education/training; nursing degree or equivalent life science degree is preferred.

• Willingness to travel is mandatory.

• Valid current passport is required.

• A valid driving license is necessary.

• Proficiency in the local languages of the countries under responsibility and strong skills in both spoken and written English.

• Exceptional oral and written communication abilities.

• Strong planning and organizational skills with effective time management.

• Excellent interpersonal skills.

• Initiative and problem-solving abilities.

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

• Experience and contributions to process improvements and developments related to monitoring and site management activities.

• In-depth knowledge of clinical research principles and processes.

• Comprehensive understanding of FDA and/or EU directives and regulations, ICH guidelines, and local regulatory requirements.

• Solid knowledge of two to three therapeutic areas to function effectively as a Lead CRA when appropriate.

• Thorough understanding of standard operating procedures.

• Proficiency in Microsoft Office.

• Experience with IxRS and EDC systems.

🏝️ 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 any other class protected by applicable law.