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 activities, initiate studies, perform interim monitoring, and carry out final site close-out visits in line with protocols, GCPs, regulations, and SOPs.

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

• Create clinical monitoring plans.

• Review site visit reports and provide constructive feedback and edits.

• Mentor and support less experienced CRAs and site personnel.

• Develop study-specific tools and templates.

• Participate in meetings with the study team, investigators, and during bid defenses.

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

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

• Compile documentation for regulatory and ethical submissions.

• Manage the shipment and receipt of study materials.

• Document findings from site visits in written reports.

• Provide insights into protocol and CRF design.

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

• Review subject safety information and informed consent documentation.

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

• Review both paper and electronic CRFs, assisting with data query resolution.

• Aid sites in maintaining the Investigator Site File.

• Maintain consistent communication with sites.

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

• Ensure site compliance regarding the receipt, accountability, and return or destruction of investigational products.

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

• Ensure quality and timely submissions of site data, safety-event reports, and follow-up actions.

• Perform additional duties as assigned.

⛳️ Requirements

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

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

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

• A nursing degree or an equivalent life science qualification is preferred.

• Willingness to travel is mandatory.

• A valid current passport is required.

• A driving license is necessary.

• Fluency in the local languages of the countries under your responsibility is essential.

• Proficiency in both spoken and written English is required.

• Comprehensive knowledge of clinical research principles and processes.

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

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

• Thorough knowledge of standard operating procedures.

• Proficiency in Microsoft Office applications.

• Familiarity with IxRS and EDC systems.

• Exceptional oral and written communication abilities.

• Strong planning, organizational, and time management skills.

• Excellent interpersonal skills, with a proactive approach and strong problem-solving capabilities.

• Ability to lead and motivate an assigned team, if applicable.

• Capability to contribute experience and insights into process initiatives and developments related to monitoring and site management activities.

🏝️ 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.