Senior Clinical Research Associate

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

📋 Description

• Conduct feasibility assessments for prospective sites

• Execute pre-study, study initiation, interim monitoring, and site close-out visits in alignment with protocols, GCPs, regulations, and SOPs

• Serve as Lead CRA for international studies and oversee CRAs

• Create Clinical Monitoring Plans

• Evaluate site visit trip reports and provide constructive 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 regulatory and ethical submission documentation

• Manage the shipment and receipt of study materials

• Document findings from site visits through written reports

• Contribute to protocol and CRF design

• Evaluate, monitor, and instruct site staff on protocol compliance

• Review subject safety data and informed consent

• Perform source document verification

• Examine paper or electronic CRFs and assist with data query resolution

• Support sites in maintaining Investigator Site Files

• Maintain consistent communication with study sites

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

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

• Conduct accompanied site visits for CRA evaluation or training

• Complete final site close-out visits and reports

• Undertake additional tasks as assigned

⛳️ Requirements

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

• A four-year college degree with a major in medical, biological, physical, health, pharmacy, or related sciences and at least five years' experience as a Clinical Research Associate

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

• Willingness to travel is mandatory

• A valid, current passport is required

• A driving license is necessary

• Proficiency in the local languages of the regions for which responsibilities are held

• Competency in both spoken and written English

• In-depth knowledge of clinical research principles and procedures

• Comprehensive understanding of FDA and/or EU Directives and regulations, ICH Guidelines, and local regulatory standards

• Strong grasp of two to three therapeutic areas

• Thorough knowledge of standard operating procedures

• Proficient in Microsoft Office

• Experienced with IxRS and EDC systems

• Exceptional oral and written communication skills

• Strong planning, organizational, and time management abilities

• Excellent interpersonal skills, initiative, and problem-solving capabilities

🏝️ 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

• Supportive and inclusive workplace environment

• Culture focused on collaboration and creativity