Clinical Research Associate Jobs

Parexel

Location:
South Korea, Seoul ▼
Remote

Category:
Research and Development

Contract Type:
Not provided

Salary:

Not provided

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Job Description:

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part to get treatments to patients sooner. Our CRAs' priority is the safety and well-being of the patients. As you travel to investigator sites and perform your monitoring duties, we encourage you to be inquisitive, take accountability, build relationships, and act with integrity. Join a team with a wide variety of experiences and knowledge, and work on global projects within a broad scope of therapeutic areas. We’re looking for people who want to grow personally and professionally and support their colleagues globally and cross-functionally.

Job Responsibility:

Act as Parexel’s direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase
Build relationships with investigators and site staff
Conduct, drive and manage country specific feasibility and/or site pre-qualification and qualification activities
Generate visit/contact reports, using judgment to identify site issues and problem solving to direct resolution
Develop strategy to configure, distribute, and collect, and review and approve, high quality country specific and/or site specific documents or essential regulatory documents (SRP) and any updated or amended regulatory documentation
Customize, review, and negotiate as needed, country/site specific Informed Consent Forms (ICF), translations, and customize and negotiate any amendments
Prepare and submit IRB/IEC and MoH/RA (if applicable) application(s), resolving conflicts, determining appropriate follow up until receipt of final approval
Submit all pertinent documentation to the trial master file as per project plans/sponsor/company policy
Forecast, develop, manage, and revise plans and strategies for IRB/IEC and MoH / RA submission/approval, Site activation, Patient recruitment & retention
Update and maintain appropriate Clinical Trial Management systems (CTMS) in a timely manner
Promptly identify, use judgment and knowledge to address and resolve or escalate, any site question and/or issue
Facilitate and support allocated sites with access to relevant study systems and ensure they are compliant with all project specific training requirements prior to study start
Actively participate in Investigator and other external or internal meetings, audits & regulatory inspections
Work in a self-driven capacity, with limited need for oversight
Proactively keep manager informed about work progress and any issues
Act as Parexel’s direct contact with assigned sites, assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites, and perform problem-solving to address and resolve site issues
Evaluate if on-site staff assignment is still accurate and determine and implement corrective actions & follow-up, if necessary / relevant
Address and resolve issues at sites, including the need for additional training, potential deficiencies in documentation, and communication
Address/evaluate/resolve issues pending from the previous visit, if any
Follow-up on and respond to appropriate site related questions
Apply working knowledge and judgment to identify and evaluate potential data quality and data integrity issues. Determine and implement appropriate follow-up action
Collect, review, and approve (if applicable) updated/amended site documentation, including regulatory documents as applicable
Evaluate site recruitment plan in collaboration with the site staff on an ongoing basis and provide strategy for improvements
Perform on-site visits
this includes Qualification and Initiation visits
apply judgment and knowledge to independently resolve site issues, questions and concerns
Conduct remote visits/contacts as requested/needed
Evaluate overall compliance and performance of sites and site staff: provide recommendations regarding site-specific actions and use judgment and experience to assess the ability and motivation of site staff
Assess & manage test article/study supply including supply, accountability and destruction/return status
Review & follow-up site payment status
Follow-up on CRF data entry, query status, and SAEs
Conduct on-site study-specific training (if applicable)
Perform site facilities assessments
Recognize impact of study non-compliance/issues/delays/changes on study timelines and communicate study issues that require immediate action, with proposed strategy for resolution
Ensure timely and accurate completion of project goals and update of applicable trial management systems
Work with team members to meet project goals, provide strategy for efficient project planning and goal completion, and encourage the support of team members where required
Update all appropriate Clinical Trial Management Systems (CTMS) on an ongoing basis
Ensure that assigned sites are audit and inspection ready
Monitor and maintain compliance with ICH-GCP and applicable international and local regulations
Delegate administrative and other tasks to Administrative Support Team as needed and where appropriate
Show commitment and perform consistent high quality work
Maintain a positive, results-orientated work environment, building partnerships and collaborative relationships
Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, Parexel SOPs, other Parexel / Sponsor training requirements and study specific procedures, plans and training
Ensure basic understanding of project scope, milestones, budgets, and strive for high quality, timely, and efficient delivery
Provide input and feedback for Performance Development Conversation(s)
Develop expertise to become a subject matter expert
Complete additional tasks in a timely manner (e.g. timesheets, expenses, metrics, etc.)

Requirements:

Strong problem solving skills
Able to take initiative and work independently, and to proactively seek guidance when necessary
Excellent presentation skills
Client focused approach to work
Ability to interact professionally within a client organization
Flexible attitude with respect to work assignments and new learning
Ability to prioritize multiple tasks, and achieve project timelines
utilizing strong analytical skills to make decision autonomously due to the unpredictable nature of the issues that arise
Strong ability to make appropriate decisions in ambiguous situations
Willingness to work in a matrix environment and to value the importance of teamwork
Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word
Excellent interpersonal, verbal, and written communication skills
Sense of urgency in completing assigned tasks and ability to assist others to meet study/country deliverables
Excellent time management in order to meet study needs, team objectives, and department goals
Proven ability to work across cultures
Shows commitment to and performs consistently high quality work
Ability to successfully work in a (‘virtual’) team environment
Consulting Skills
Able to accommodate travel time requirements, according to tasks allocation/phase of the study assigned
Act as a mentor and role model for other team members
Effectively enlist the support of team members in meeting goals
Attention to detail
Holds a driver’s license where required

Nice to have:

Communicator
Detail-oriented
Flexible
Organized
Problem-solver
Self-starter

What we offer:

Patient-focused in everything we do
Supportive and inclusive environment
Career growth and development
Flexible work arrangements
Diverse therapeutic areas and project exposure
Advanced Technology

Additional Information:

Job Posted:
December 11, 2025

Work Type:

On-site work

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Clinical Research Associate