Senior Clinical Research Associate

Worldwide Clinical Trials

. Perform feasibility studies for potential sites .

Posted 9/29/2026full-timeRemote • South KoreaSeniorWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates extensive understanding of clinical research principles, FDA and EU regulations, and ICH Guidelines while effectively leading and mentoring teams in site management and monitoring activities. Proficient in developing Clinical Monitoring Plans and conducting training for study team members.

Highest-signal resume keywords

Clinical Research Associate ExperienceLead CRA ResponsibilitiesRegulatory Compliance KnowledgeFluent in Local Languages and EnglishProficiency in Microsoft Office

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Clinical Monitoring PlansSource Document VerificationProtocol Adherence AssessmentData Query ResolutionRegulatory Submission DocumentationStudy-Specific Tool DesignInvestigator Site File MaintenanceTherapeutic Area KnowledgeClinical Research PrinciplesStandard Operating Procedures

Soft Skills

Excellent Communication SkillsPlanning and Organizational SkillsInterpersonal SkillsInitiative and Problem SolvingTeam Leadership and Motivation

Tools & Technologies

IxRS SystemsEDC SystemsMicrosoft Office

Certifications & Qualifications

Medical Doctor (MD)Pharmacist (MSPH, PharmD, PhD)

Industry Keywords

Clinical ResearchFDA RegulationsEU DirectivesICH GuidelinesSite Management

About the role

Key responsibilities & impact

Perform feasibility studies for potential sites
Conduct pre-study, study initiation and interim monitoring visits in adherence to protocol requirements
Function as Lead CRA for global studies and coordinate CRAs
Develop Clinical Monitoring Plans as requested
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 study material shipment and receipt by sites
Document site visit findings through written reports
Provide input into protocols and CRFs
Assess, monitor and train site staff on protocol adherence
Review subject safety information and informed consent
Conduct source document verification for compliance, patient safety and data veracity
Review paper or electronic CRFs and assist with data query resolution
Assist with Investigator Site File maintenance
Maintain regular communication with 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 visit and report
Perform other assigned duties

Requirements

What you’ll need

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; nursing degree or equivalent life science degree preferred
Willingness to travel required
Valid current passport required
Driving license required
Fluent in the local languages of the countries under responsibilities and proficient in both spoken and written English
Excellent oral and written communication skills
Excellent planning and organizational skills with effective time management
Excellent interpersonal skills
Initiative and problem solving skills
Ability to lead and motivate assigned team, if applicable
Experience and input into process initiatives and development relating to monitoring and site management activities
Extensive understanding of clinical research principles and process
Thorough understanding of FDA and/or EU Directives and regulations, ICH Guidelines and local regulatory requirements
Thorough understanding of two to three therapeutic areas sufficient to function as a Lead CRA as appropriate
Thorough understanding of standard operating procedures
Proficiency in Microsoft Office
Proficiency with IxRS and EDC systems

Benefits

Comp & perks

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