パレクセルでの仕事
パレクセルは、臨床開発の上流から下流までのそれぞれの専門領域で、国内外の多くのお客様に高度なソリューションを提供するプロフェッショナル集団です。 パレクセルは、新しい薬や治療法を、それらを必要としている人々にいち早く届けることを目指し、日々の業務に取り組んでいます。
Initiation Clinical Research Associate II
応募 求人ID 64639BR ロケーション ワルシャワ, マゾフシェ県 仕事内容We are hiring an Initiation Clinical Research Associate for our Warsaw office. Candidates must have strong previous study start up experience, please apply below if you are interested and have the relevant SSU expertise.
Main responsibilities:
Main responsibilities:
- Act as Parexel’s direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase.
- Conduct, drive and manage country specific feasibility and/or site pre-qualification and qualification activities.
- Customize, review, and negotiate as needed, country/site specific Informed Consent Forms (ICF), translations and customize and negotiate any amendments.
- Forecast, develop, manage, and revise plans and strategies for IRB/IEC 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, 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.
- 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.
Qualifications
Ideal candidate will possess:
- Life Science degree
- Advanced level study set up, site initiation, or study start up experience experience working in a clinical research environment, with a good understanding of both clinical trials methodology and terminology.
- Understanding and knowledge of Clinical Site Agreement (CSA) and site contracts experience is desirable (but not mandatory) working with both new studies and existing study amendments.
- 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.
- Fluent English and Polish
- 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
