Parexel is hiring a Clinical Research Associate I - II to join our Core Team (코어팀). In this role, you will be responsible for managing clinical trial sites from start-up through close-out, acting as Parexel's direct point of contact to ensure quality, protocol adherence, and to build strong investigator relationships.
What You'll Do
- Act as Parexel’s direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase.
- Build and maintain positive relationships with investigators and site staff.
- Conduct and manage country-specific feasibility and site pre-qualification/qualification activities.
- Prepare, negotiate, and facilitate execution of Confidentiality Agreements (CDAs), Clinical Site Agreements (CSAs), and amendments.
- Conduct remote Qualification Visits (QVs) and other visits as required per study.
- Generate visit reports, identify site issues, and direct problem-solving for resolution.
- Develop strategy for collection and review of essential regulatory documents (SRP).
- Customize, review, and negotiate country/site specific Informed Consent Forms (ICFs) and translations.
- Prepare and submit IRB/IEC and MoH/RA applications, following up for final approval.
- Submit all pertinent documentation to the trial master file per project plans and policy.
- Forecast, develop, manage, and revise plans for IRB/IEC approvals, site activation, and patient recruitment & retention.
- Update and maintain Clinical Trial Management systems (CTMS) in a timely manner.
- Promptly identify, address, resolve, or escalate site questions and/or issues.
- Facilitate site access to study systems and ensure compliance with training requirements.
- Actively participate in Investigator meetings, audits, and regulatory inspections.
- Work in a self-driven capacity with limited need for oversight, proactively keeping your manager informed.
- Assess and ensure the overall integrity of study implementation and protocol adherence at sites.
- Evaluate on-site staff assignments and implement corrective actions as necessary.
- Address site issues including training needs and documentation deficiencies.
- Apply working knowledge to identify and evaluate potential data quality and integrity issues.
- Collect, review, and approve updated/amended site and regulatory documentation.
- Evaluate site recruitment plans and provide strategy for improvements.
- Perform on-site visits (Qualification, Initiation) and remote visits/contacts as needed.
- Evaluate overall compliance and performance of sites and site staff.
- Assess and manage test article/study supply accountability and status.
- Review and follow up on site payment status.
- Follow up on CRF data entry, query status, and SAEs.
- Conduct on-site study-specific training where applicable.
- Perform site facilities assessments.
- Recognize the impact of study non-compliance on timelines and communicate issues requiring immediate action.
- Ensure timely and accurate completion of project goals and system updates.
- Work with team members to meet project goals and provide strategy for efficient planning.
- Ensure assigned sites are audit and inspection ready.
- Monitor and maintain compliance with ICH-GCP and applicable international and local regulations.
- Delegate administrative tasks to the Administrative Support Team and guide their work.
- Maintain a positive, results-orientated work environment and open communication.
- Maintain a working knowledge of and ensure compliance with ICH-GCP Guidelines, regulations, SOPs, and study procedures.
- Understand project scope, milestones, and budgets, striving for high-quality, timely delivery.
- Provide input for Performance Development Conversations.
- Develop expertise to become a subject matter expert.
- Complete additional administrative tasks in a timely manner (e.g., timesheets, expenses, metrics).
What We're Looking For
- Minimum of 1 year of experience in a CRA role for permitted clinical trial monitoring.
- Strong problem-solving skills and the ability to take initiative and work independently.
- Ability to prioritize multiple tasks and achieve project timelines.
- Strong ability to make appropriate decisions in ambiguous situations.
- Willingness to work in a matrix environment and value teamwork.
- Strong computer skills including knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products.
- Excellent interpersonal, verbal, and written communication skills.
- Sense of urgency in completing assigned tasks and excellent time management.
- Proven ability to work across cultures and in a (‘virtual’) team environment.
- Shows commitment to and performs consistently high quality work.
- Able to accommodate travel time requirements according to the study phase and task allocation.
- Attention to detail and a valid driver’s license where required.
Nice to Have
- Excellent presentation skills and a client-focused approach to work.
- Ability to interact professionally within a client organization.
- Flexible attitude with respect to work assignments and new learning.
- Consulting skills.
- Ability to act as a mentor and role model for other team members.
- Effectively enlist the support of team members in meeting goals.
Technical Stack
- Clinical Trial Management System (CTMS)
- Electronic Document Management System (EDMS)
- MS-Office products (Excel, Word)
Team & Environment
You will be working within our Core Team (코어팀) structure, collaborating closely with colleagues in a matrix environment. Our culture is built on sharing the goal to improve the world's health, taking work personally with empathy, and maintaining a deep conviction in what we do. We foster a positive, results-orientated work environment focused on building partnerships and collaborative relationships.
