Clinical Research AssociateⅡ

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. 

Purpose

Describe the primary goals, objectives or functions or outputs of this position.

To enable AbbVie’ s emergence as a world class R&D organization, the position anticipates and proactively solves study-related clinical site issues as they occur and initiates, recommends and communicates corrective action ensuring successful protocol level execution of SMM deliverables involving start-up, execution, and close-out of studies.

Responsibilities

List up to 10 main responsibilities for the job. Include information about the accountability and scope.

• Monitors activities conducted by clinical investigative sites as they relate to AbbVie clinical studies to ensure successful execution of the protocol. Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research.
• Conducts site qualification, initiation, interim monitoring and study closeout visits for Phase 1-4 studies in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, and AbbVie Standard Operating Procedures (SOPs) and business processes.
• Overviews the overall activities of site personnel over whom there is no direct authority and motivates/influences them to meet study objectives. proactively manages the site and ensures action plans are put into place as needed to ensure compliance. Ensures regulatory inspection readiness at assigned clinical sites.
• Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.
• Ensures safety and protection of study subjects through compliance with the study monitoring plan, AbbVie SOPs, ICH Guidelines, and applicable regulations.
• Trains study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members.
• Manages investigator payments as per executed contract obligations. Negotiates investigator/ hospital agreements with stakeholders. Maintain and complete own expense reports as per local and applicable guidelines.
• Identifies, evaluates and recommends new/potential investigators/sites on an on­ going basis. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators.

Qualifications

List required and preferred qualifications (up to 10). Include education, skills and experience.

• Appropriate tertiary qualification, health related (e.g., Medical, Scientific, Nursing) preferred.
• Minimum of 1 year of clinically-related experience, of which a period of 6 months is preferable in clinical research monitoring. Experience in on-site monitoring of investigational drug or device trials is required
• Current in-depth knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials.
• Current in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations.
• Strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines. Ability to work, understand and follow work processes within the assigned function.
• Strong analytical and conceptual capabilities, interpersonal skills, and ability to communicate with clarity. Ability to address study related clinical site issues with appropriate guidance and initiates and communicate corrective action as indicated. Ability to use functional expertise and exercise good judgment.
• Demonstrated business ethics and integrity.
• Experience as a team leader is preferred.
• Experience as a CRA or CRA leader in oncology therapeutic area is preferred.
• English: intermediate to business level
• Japanese: business level to native level

AbbVieは、誠実な事業運営、イノベーション推進、人々の生活の変革、地域社会への貢献、そしてダイバーシティ＆インクルージョンの促進などに尽力しています。AbbVieの採用方針は、人種や肌の色、宗教、国籍、年齢、性別（妊娠を含む）、身体的・精神的障がい、病気、遺伝情報、性同一性または表現、性的指向、婚姻状況、退役軍人やその他法的に保護されたグループに属するかどうか等に関わらず、高い能力を持つ優秀人財を従業員や候補者として差別することなく雇用することです。　

AbbVieは、誠実な事業運営、イノベーション推進、人々の生活の変革、地域社会への貢献、そしてダイバーシティ＆インクルージョンの促進などに尽力しています。AbbVieの採用方針は、人種や肌の色、宗教、国籍、年齢、性別（妊娠を含む）、身体的・精神的障がい、病気、遺伝情報、性同一性または表現、性的指向、婚姻状況、退役軍人やその他法的に保護されたグループに属するかどうか等に関わらず、高い能力を持つ優秀人財を従業員や候補者として差別することなく雇用することです。