Clinical Research Associate

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ポジション概要

臨床試験の進捗状況をモニタリングし、試験がプロトコル、標準業務手順書（SOP）、Good Clinical Practice（GCP）、および適用される規制要件に従って実施、記録、報告されていることを保証する責任を負う。

また、施設（Site）レベルにおいて、社内外のステークホルダーとの連絡窓口を担う。

職務／責任

• 社内外のステークホルダーとの継続的な協働を通じて、治験責任医師候補（Investigator）を特定する
• 治験責任医師候補およびその施設について、臨床試験を実施するためのリソースおよび能力（Capability）を有しているかを評価する
• 施設との関係構築をする（CRO関連の管理、非承認申請目的／医師主導研究を含む）
• 施設の実施可能性評価および／または施設選定プロセスにおいて、施設を選定する
• 必要に応じて、試験開始前訪問（Pre-study Visit）を実施する
• 施設開始前に、治験責任医師および施設スタッフがプロトコルに特化した十分なトレーニングを受けられるよう、Site Initiation Visitを実施する
• オンサイトおよびオフサイト訪問を通じて、施設での活動および品質を確認する
• モニタリング計画、BMSの手順書、プロトコル、ICH/GCPガイドライン、ならびに適用される各種ローカル規制に従い、モニタリング業務を実施し、被験者の安全の保持および人権の保護を確保する
• （必要に応じて）盲検性を保護するため、ブラインドモニターとは独立して、アンブラインドモニター業務を実施する
• モニタリングにおいて、データを活用してリスクを評価し、課題を特定し、適切な判断を行う能力を示す
• 施設の主要な連絡窓口となる
• 施設に対してトレーニングを提供する
• 必要なすべてのプロトコル訪問およびフォローアップが完了した後、施設クローズ業務を実施する
• 割り当てられた施設に基づき、複数の治療領域や複数のプロトコルを担当する（出張を伴う場合あり）
• 施設から提出されるデータの完全性および品質を保証する
• 利用可能なシステムを用いて施設の活動をフォローし、eCRFデータが最新かつ利用可能な状態であることを確保する
• 臨床試験に関わる施設スタッフの活動をモニタリングする
• 症例登録等試験目標を達成できるよう、施設をmotivateし、影響を与える
• 各ステークホルダーに応じて最適なコミュニケーションを実践し、高い柔軟性および適応力を発揮する
• 発生し得る課題を予測・特定し、発生時には施設を積極的に支援して解決を図る。重大または継続的な未解決課題については、適切に文書化し、速やかにマネジメントおよびプロジェクトチームへエスカレーションする。根本原因分析に基づき、是正・予防措置を開始・提案・文書化・共有し、実施状況をフォローアップする
• 必要に応じて、監査／査察対応に関与する（施設の是正・予防措置の策定および実施を含む）
• モニタリング報告書および管理関連の書面報告書を、タイムリーかつ正確、簡潔、専門的、客観的に作成・提出する
• 倫理委員会/IRBへの申請、ICFレビュー、施設との文書授受を支援する場合がある
• 臨床試験施設スタッフがEDCおよびBMS／ベンダーシステムへアクセスできるよう支援する場合がある
• 機器の校正およびトラッキングを支援する場合がある
• Site Initiation Visitに関連した資料の準備を支援する場合がある
• 日本の要件に基づき、データベースロックの期限遵守に向けた調整を支援する場合がある

シニアレベルの期待事項（Senior Clinical Research Associate に適用）

• 施設レベルおよび国レベル双方において、潜在的な問題を主体的に特定・解決する
• Clinical Trial Managerおよび／またはLine managerと連携し、より複雑な課題の解決を支援する
• グローバルを含む社内および関連するすべての外部関係者とのコミュニケーションスキル向上を主体的に図り、他者にも指導する
• 試験チームへの重要な貢献を行い、施設スタッフを指導して施設およびハブのパフォーマンス向上に寄与する
• 指導、トレーニング、メンタリング（非公式／公式プレゼンテーションを含む）を通じて、同僚に対する主要なリソースとして機能する
• モニタリング権限付与およびOn going assessmentについて、Line Managerを支援する場合がある
• RCOの判断により、日本における試験のLead CRAに任命される場合がある

報告ライン

Regional Clinical Operations Japan における Clinical Research AssociateグループのLine managerへの直属報告

資格要件

学歴要件

• 生命科学分野を中心とした学士号、または同等の学位

経験要件

• Associate Clinical Research Associate：臨床研究に関連する実務経験または教育経験 1年以上
• Clinical Research Associate：臨床研究に関連する実務経験 2～3年、独立して業務遂行可能
• Senior Clinical Research Associate：モニタリング経験5年以上。リーダーシップ、メンタリングおよびコーチング能力を有すること
• 製薬／バイオテック企業スポンサーでの勤務経験、または治験コーディネーターとしての経験があれば尚可
• 医薬品の創薬／開発プロセスに関する経験

主要コンピテンシー

• ICH/GCPガイドラインおよび臨床試験を規定するローカル法規制（規制当局）に関する基礎～良好な知識
• 臨床研究プロセス、規制、方法論に関する理解
• 多様な医療現場および医療記録管理に関する実務的知識を含む、臨床環境への理解
• 組織力およびタイムマネジメント能力
• プレッシャー下や困難な状況においても、関係構築・維持・強化ができる能力
• 英語およびローカル言語での優れた口頭および文書コミュニケーション能力　英語：OPAスコア4超、またはビジネスレベルでステークホルダーとやり取りできる能力
• Microsoft Office（Microsoft Suite）
• Clinical Trial Management System（CTMS）の使用能力
• 以下のソフトウェアを自立して使用できること
  （Microsoft Suite、CTMS、Electronic Data Capture（eDC）、Electronic Trial Master File（eTMF）、Metrics関連Webサイト）

出張

• モニタリング計画に記載された指示に従って出張できること

Position Summary

Responsible for the oversight of the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s). Act as one of the points of contact at a Site level for internal and external stakeholders.

Duties/Responsibilities

• Identifies new potential Investigators, through ongoing collaborations with internal and external stakeholders.
• Assesses potential Investigators and their sites to ensure they have the resources and capabilities to conduct clinical trials.
• Develop Site relationships (incl. Contract Research Organization related issue management and non- registrational /Investigator Sponsored Research Studies).
• Recommends sites during the site feasibility and/or site selection process
• Conducts pre-study visit as appropriate.
• Conducts initiation visits to ensure Investigator and site personnel receives adequate protocol specific training prior to site activation.
• Reviews site activities and quality through on-site and off-site visits. Conducts monitoring activities and ensures safety and protection of study subjects as per the monitoring plan, BMS procedural documents, protocol, ICH/GCP Guidelines and other local regulations as applicable.
• Perform Unblinded Site Monitor activities to protect the blind of the study by acting as secondary monitoring source separate from the blinded monitor.
• While monitoring demonstrates the ability to use data to assess risks, identify issues and make appropriate decisions.
• Serve as a point of contact for Sites.
• Provides trainings to sites.
• Performs site closure activities when all required protocol visits and follow-up are completed.
• Manages multiple protocols, across multiple therapeutic areas, which may require travel, based upon assigned site location and/or geographic territory.
• Ensures completeness and quality of data submitted from study sites.
• Ensures eCRF data is available and current by using the available systems to follow site activities.
• Oversees activities of site personnel over whom there is no direct authority.
• Motivates/influences the site to meet study objectives, including enrolment and retention goals. Demonstrates flexibility and adaptability when communicating with different stakeholders utilizing the most appropriate communication method.
• Anticipates, identifies and proactively supports site in resolving issues as they occur. Appropriately documents and promptly escalates serious or persistent outstanding issues to management and project team. Initiates, recommends, documents and communicates corrective actions as needed and follows up to ensure corrective/preventive actions based on root cause analysis are implemented.
• Involvement in Regulatory Compliance audit/inspection process, as needed. This includes the development and implementation of site corrective and preventive actions.
• Prepares and submits written reports, both monitoring and administrative, in a timely, accurate, concise, professional and objective manner.
• May support Ethics Committee submission, ICF review, collection of documents to/from site.
• May support ensuring access to eDC and BMS / vendor systems is available for clinical trial site personnel.
• May support equipment calibration and tracking.
• May support preparation of Study Initiation Visit materials.
• May support coordination and ensure database lock timelines are met as required locally.

Senior Level Expectations: (Applicable for Senior Clinical Research Associate)

• Proactively identify and resolve potential problems at both site and country level.
• Engage with Clinical Trial Manager and/or line management to assist in the resolution of more complex issues.
• Proactively seek to enhance communication skills with both internal (Global level) and all relevant external parties and coaches others to do the same.
• Contribute significantly to study team and coaches site staff to enhance site and hub performance.
• Serve as a key resource for colleagues, by providing guidance, leading training and mentoring to other team members through a mentoring process using informal and/or formal presentations.
• May assist line management with conducting monitoring authorizations and ongoing assessments
• May be assigned as a Lead CTMo for a study locally and as determined by RCO Country/Cluster leadership.

Reporting Relationship

Straight line reporting to Line Manager of Clinical Research Associate Group, RCO-Japan

Qualifications

Degree Requirements

• Bachelors degree required preferably within life sciences or equivalent.

Experience Requirements

• Associate Clinical Research Associate: 1 year of relevant clinical research experience and/or relevant educational experience.
• Clinical Research Associate: 2-3 years of relevant clinical research experience, able to work independently.
• Senior Clinical Research Associate: At least 5 years of monitoring experience. Demonstrate leadership skill, mentor and coach capability.
• Relevant prior Pharma/Biotech Sponsor employment or experience as a clinical study coordinator preferred.
• Experience in the drug discovery/development process.

Key Competency Requirement

• Has basic to good knowledge of ICH/GCP Guidelines and applicable local laws and regulations (Health Authorities) which govern clinical trials.
• Knowledge and understanding of clinical research processes, regulations and methodology.
• Understands clinical landscape with practical knowledge of a variety of medical settings and medical records management.
• Organization and time management skills
• Ability to build, maintain and strengthen relationships even under pressure and/ or in difficult situations.
• Good verbal and written communication skills (both in English and local language). For English, OPA Score >4 or business level ability to interact with the stakeholder.
• Microsoft Suite
• Able to work with Clinical Trial Management Systems (CTMS)
• Software that must be used independently and without assistance (Microsoft Suite, Clinical Trial Management Systems (CTMS), Electronic Data Capture Systems (eDC); Electronic Trial Master File (eTMF), Metrics Websites).

Travel Required

• Capability to travel according to the instruction stated in the monitoring plan

The English version is the original and the Japanese version is for reference purposes. 

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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R1599859 : Clinical Research Associate