临床研究助理 II - 免疫学 - 底特律
Clinical Research Associate II - Immunology- Detroit
关于艾伯维
艾伯维的使命是发现并提供创新药物和解决方案，以解决当今严重的健康问题，并应对明天的医疗挑战。我们致力于在免疫学、肿瘤学和神经科学等多个关键治疗领域对人们的生活产生显著影响，以及我们在Allergan Aesthetics产品组合中的产品和服务。如需了解有关艾伯维的更多信息，请访问我们的网站 www.abbvie.com。关注我们在 LinkedIn、Facebook、Instagram、X 和 YouTube 上的账号。
职责
通过在临床研究中追求卓越，推进艾伯维的研发管线，将科学转化为患者可用的药物，并利用新的先进能力推动行业领先的绩效表现。
与研究者和现场工作人员合作，进行有意义且有效的互动，使艾伯维成为临床试验的首选。
专注于现场临床研究，确保试验的适当执行，同时推动数据完整性、合规性、整体研究表现和客户体验的改进。
职责
· 作为研究现场的主要联系人。具备高水平的专业能力或经验，能够提供关于临床试验的背景信息，将利益相关者与研究现场连接起来，并加强艾伯维的定位。
· 与现场工作人员和主要研究者对临床试验项目的目标、方案和试验患者的治疗原则进行对齐、培训和激励，确保建立信任合作关系。
· 按照适用的法规、良好临床实践（GCP）、ICH指南、艾伯维标准操作程序（SOP）和质量标准，进行现场评估、现场培训、常规和现场关闭监测活动，确保受试者的安全和保护。
· 对现场参与有深入的理解，并能够为指定的研究制定定制化的现场参与策略。收集本地/现场见解，并利用客户关系管理（CRM）工具等现场参与工具来报告/跟踪进展并衡量该策略的影响。
· 高水平的专业能力，能够将研究方案、科学原理和临床试验要求与日常临床试验执行活动相连接。根据患者疾病旅程评估并确保有效的招募和保留技术/计划。
发展扎实的知识
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About AbbVie
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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Purpose
Advance AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for our patients and leveraging new advanced capabilities to drive industry leading performance.
Partners with the investigator and site staff for meaningful and effective engagements positioning AbbVie as the choice in clinical trials.
Focus on site clinical research that ensures appropriate conduct of the trial while driving improvement in data integrity, compliance, overall study performance and customer experience.
Responsibilities
· Considered as the primary point of contact for the investigative site. High level of competency or experience in providing contextual information on the clinical trials, connects stakeholder to the investigative sites and strengthens AbbVie’s positioning.
· Aligns, trains and motivates the site staff and principal investigator on the goals of the clinical trial program, protocol and patient treatment principles for the trial ensuring a trusted partnership.
· Conducts site evaluation, site training, routine, and site closure monitoring activities with compliance to the protocol and monitoring plans, in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards, ensuring safety and protection of study subjects.
· Advanced understanding of site engagement and ability to customize site engagement strategy for assigned study (ies). Gather local/site insights and utilize site engagement tools such as the Customer Relationship Management (CRM) tool, to report/track progress and measure impact of that strategy.
· Advanced level of competency connecting the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities. Evaluate and ensure effective recruitment and retention techniques/plans based on the patient disease journey.
Develop solid knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance.
· Possesses experienced level of competency to mentor and train less experienced CRAs on various aspects of work and provides input into their development.
May participate in global/local task forces and initiatives. Responsible for activities as assigned by manager.
· Responsible for continuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues.
· Advanced ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution. Ensures preventative and corrective action plans are put into place, as needed, to mitigate risk and promote compliance using a customer centric approach.
· 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.
· 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 audit and regulatory inspection readiness at assigned clinical site at all times.
Manages investigator payments as per executed contract obligations, as applicable.
Qualifications
· Appropriate tertiary qualification in health related disciplines (Medical, Scientific, Nursing) preferred.
· Minimum of 1 year of clinically related experience, of which a period of 6 months is required in clinical research monitoring of investigational drug or device trials. Familiar with risk‐based monitoring approach, onsite and offsite monitoring.
· Knowledge of appropriate therapeutic area indications is preferred with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials.
· Advanced knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies.
· Demonstrate strong cross-functional collaboration skills among internal and external stakeholders.
· Demonstrate strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
· Advanced ability to leverage technology, tools and resources to provide customer centric support based on the health of the site.
· Strong interpersonal skills with excellent written, verbal, active listening and presentation skills, with ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training.
· Ability to use functional expertise with appropriate guidance, leverage critical thinking skills and apply good judgement to address clinical site issues.
· Acts with integrity in accordance with AbbVie code of business conduct and leadership values. Self-motivated individual focused on delivering timely and quality outcomes in a fast-paced environment.
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
· The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
· We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
· This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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