Japanese English Bilingual Research Associate
Job ID R0000032318 Category Clinical TrialsAbout this Role
Parexel Early Phase Clinical Unit supports the development of innovative new medicines which are vital for public health, improving outcomes, and saving lives. The early phase and “first in human” trials are the first step in testing these novel treatments in humans.
Parexel Early Phase Clinical Unitは、公衆衛生にとって重要で、治療成績を向上させ、生命を救うために不可欠な新薬の開発をサポートしています。早期臨床試験および”First in human”試験は、これらの新規治療薬を初めてヒトに投与する段階です。
At Parexel Glendale, CA unit our highly trained and skilled Research Associates are crucial to ensuring the successful completion of Phase I trials. This is a great role for anyone that aspires to be an enrollment specialist, clinical research coordinator, or eventually manager. Parexel provides a great system of support to help you grow and advance your career internally.
Parexel Glendale, CA Unitでは、高度なトレーニングを受けたリサーチアソシエイトが、第Ⅰ相試験を成功に導くうえで重要な役割を果たしています。エンロールメントスペシャリスト、治験コーディネーター、あるいは将来的には管理職を目指す方にとって素晴らしいポジションです。パレクセルは、社内でキャリアアップを目指せる機会を提供することができます。
What you’ll do after training is completed (including but not limited):
- You will understand study protocols and be able to complete required medical procedures
- Recruit study participants by calling the database, attending company sponsored community events, posting flyers in schools, senior centers, supermarkets, and other establishments.
- Enter study participants in the study participant tracking system and study logs, maintain appointment calendars, and operate company information systems and computer programs.
- Conduct screening visits and study protocol specific study participant visits, assist staff physicians in assessment of concomitant medications, adverse events, lab results, and other test results.
- Prepare/monitor study supplies and stock levels in clinic/hospital.
- Label, inventory, and send plasma samples.
- Problem solve study participant issues as they arise.
- Ensure basic study participant safety is provided
- Assist with Monitor visits (i.e., room set up, etc.).
- Identify issues that need Sponsor approval and bring these to the attention of the CRC.
- Maintain and update knowledge of Clinical Operating Guidelines and their proper application.
- Assume appropriate role with study participants and caregivers.
- Assure quality and accuracy of source and CRF documentation.
- Comply with Quality Management (QM) department guidelines and perform corrections for QM, CRC and Monitor/Sponsor Representative in a timely manner.
トレーニング完了後の業務 (以下を含みますが、これらに限定されるものではありません)：
- 治験実施計画書を理解し、必要な医療処置を実施します。
- データベース登録者への電話、企業主催の地域イベントへの参加、学校、高齢者センター、スーパーマーケット、その他施設でのチラシ掲示などを通じて、治験参加者を募集します。
- 治験参加者追跡システムおよび治験記録に治験参加者情報を入力し、予約カレンダーを管理、会社のシステムを操作します。
- スクリーニング来院と治験実施計画書に基づく治験参加者の来院を実施し、併用薬、有害事象、臨床検査結果、その他の検査結果の評価において医師を補助します。
- クリニック/病院内の治験用資材を準備、在庫状況を管理します。
- 血漿サンプルのラベル貼り、在庫管理、発送を行います。
- 治験参加者に問題が発生した場合は、その問題を解決します。
- 治験参加者の基本的な安全性が確保されていることを保証します。
- モニター訪問の補助を行います (例：部屋の準備など)。
- 治験依頼者の承認が必要な問題を特定し、CRC に注意喚起をおこないます。
- 臨床業務ガイドラインの知識を維持・更新し、適切に運用します。
- 治験参加者および介護者に対して適切な対応を行います。
- 原資料およびCRF の文書化の質と正確性を確保します。
- 品質管理 (QM) 部門のガイドラインを遵守し、QM、CRC、モニター/治験依頼者の担当者からの指摘事項に対して適時に修正をおこないます。
Your Profile:
- Customer service experience in a fast-paced environment
- Fluent in written and spoken English and Japanese
- Patient Care experience highly preferred
- Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
- B.S.+ in related life science field OR HS diploma/GED with relevant experience
求める人物像：
- 忙しい環境でのカスタマーサービス経験
- 英語と日本語の読み書き、会話が流暢であること
- 患者ケアの経験者歓迎
- 熱意をもってマルチタスクを管理し、細部に注意を払いながら業務の優先順位をつける能力
- ライフサイエンス分野での学士号以上、または高校卒業と同等以上の学力及び関連する経験のある方
Base Pay Range: $20.00 to $25.00 per hour
Actual salaries may vary within the range based on several factors including, but not limited to education, training, experience, professional achievement, and location.
In addition to base salary, some roles may be eligible for participation in Parexel’s annual performance-based bonus plan, annual salary review and additional total rewards incentives.
Our talent acquisition team will provide additional details on our bonus plan or incentive programs for those eligible roles. For all eligible employees, we offer market leading benefit programs including paid time off, 401k match, life insurance, health insurance, and other benefit offerings in accordance with the terms of applicable plans.
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
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