Clinical Research Associate (코어팀)

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

*코어팀 CRA 채용 중*

*CRA로 허가임상 과제 모니터링 만 1년 이상 경력자 지원 가능*

-> 인터뷰 후 경력 사항에 따라 CRA I, II, or Senior 타이틀 오퍼 예정

*CRA 업무 스콥은 Maintenance 부분 참고 부탁드립니다.*

*Protocol & ICF amendment 진행 및 In-house work 서포트가 있어 In-house 업무 로드를 덜어드리고 있습니다. (SUSAR reporting, 통관, 연구비 정산 follow up, IRB 문서 다운로드/ 번역 의뢰/ naming 등)*

Key Accountabilities:

Start-up (from site identification through pre-initiation):

Act as Parexel’s direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase.
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Build relationships with investigators and site staff.

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Conduct, drive and manage country specific feasibility and/or site pre-qualification and qualification activities, which may include:

-Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments.
-Conduct remote Qualification Visits (QVs).
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Generate visit/contact reports, using judgment to identify site issues and problem solving to direct resolution.

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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.

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Customize, review, and negotiate as needed, country/site specific Informed Consent Forms (ICF), translations (within parameters of country/regulatory/client requirements), and customize and negotiate any amendments.

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Prepare and submit IRB/IEC and MoH/RA (if applicable) application(s), resolving conflicts, determining appropriate follow up until receipt of final approval.

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Submit all pertinent documentation to the trial master file as per project plans/sponsor/company policy.

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Forecast, develop, manage, and revise plans and strategies for:

-IRB/IEC and MoH / RA submission/approval,
-Site activation,
-Patient recruitment & retention.
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Update and maintain appropriate Clinical Trial Management systems (CTMS) in a timely manner.

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Promptly identify, use judgment and knowledge to address and resolve or escalate, any site question and/or issue, including but not limited to: potential issues or risks with site activation timelines, issues with patient recruitment strategy, deficiencies in training, data quality or integrity, study non-compliance, etc.

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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.

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Actively participate in Investigator and other external or internal meetings, audits & regulatory inspections

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Work in a self-driven capacity, with limited need for oversight.

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Proactively keep manager informed about work progress and any issues.

Maintenance (from initiation through close out):

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.
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Build relationships with investigators and site staff.

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Facilitate and support site with access to relevant study systems and ensure sites are compliant with project specific training requirements.

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Evaluate if on-site staff assignment is still accurate and determine and implement corrective actions & follow-up, if necessary / relevant.

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Address and resolve issues at sites, incl