高级临床研究专员
Senior Clinical Research Associate
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，并应对未来的医疗挑战。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。有关艾伯维的更多信息，请访问我们的网站www.abbvie.com。关注LinkedIn、Facebook、Instagram、X和YouTube上的@abbvie。
主要职能/目标
为使艾伯维成为世界级的研发机构，该职位在确保涉及研究启动、执行和结题的SMM交付物协议层面的成功执行方面发挥关键作用。
核心工作职责
· 对指定的站点/研究，确保涉及研究启动、执行和结题的SMM交付物在协议层面的成功执行。确保与站点相关的研究执行，包括但不限于监查访视、站点评估、站点选择和激活，以及监查结题和访视报告。预见并识别可能影响时间表的站点问题，并制定替代解决方案。
· 确保包含所有站点特定信息的临床试验管理系统得到维护并保持最新。提供本地监管和法律要求的专业知识。根据临床研究协议和当地要求，及时执行指定站点/研究的付款。
· 确保遵守联邦法规和适用的当地法规、良好临床实践（GCP）、ICH指南、艾伯维标准操作程序（SOP）、监查计划和临床研究的质量标准。了解新的或不断演变的当地法规、指南和政策。
· 确保指定站点的审计和检查准备就绪。就GCP要求的预审计活动提供建议。准备并跟进站点审计/检查；参与CAPA准备。
· 负责指导和辅导CRAs，并为其发展提供意见。负责对CRAs在各项工作方面的指导。
· 可能负责作为指定研究中CRO的国家联系人。可能参与或领导全球/本地工作组和项目。负责经理指派的活动。
· 如果被指派；负责识别培训需求，并标准化和促进培训。
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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.
PRIMARY FUNCTION/OBJECTIVE
To enable AbbVie’s emergence as a world class R&D organization, the position plays a key role in ensuring successful protocol level execution of SMM deliverables involving start-up, execution, and close-out of studies.
CORE JOB RESPONSIBILITIES
· For assigned sites/study(s), ensure successful protocol level execution of SMM deliverables involving start-up, execution, and close-out. Ensure site related study execution including but not limited to monitoring visits, site evaluations, site selection, and activation, and monitoring close out and visit reports. Anticipate and identify site issues that could affect timelines and develop alternative solutions.
· Ensure clinical trial management systems containing all site-specific information are maintained and kept current. Provide Local regulatory and legal requirement expertise. Ensures timely payment execution for the assigned sites/study(s) according to the clinical study agreements and as per local requirements.
· Ensure 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. Stay abreast of new and/or evolving local regulations, guidelines and policies.
· Ensure audit and inspection readiness of assigned sites. Advise on pre-audit activities for GCP requirements. Prepare and follow up site audits/inspections; provide input into the CAPA preparation.
· Responsible for coaching and mentoring CRAs and providing input into their development. Responsible for mentoring CRAs for various aspects of work.
· May be responsible for being the country point of contact for CROs for an assigned study. May participate/lead in global/local task forces and initiatives. Responsible for activities as assigned by manager.
· If assigned; Responsible for identifying training needs and standardizing and facilitating training solutions for SMM monitors globally. Provide consistent best practice approach to onboarding, consolidating“lessons learned” across areas and incorporating into monitoring training materials, defining best practice training curriculum, and maintaining awareness of upcoming changes to ensure effective training is delivered in a timely manner.
· If assigned; With guidance, may serve as key point of contact in country/district for assigned study. Update Impact/Tesla with country-level information: Country-level planning timelines, LSR assignments, etc.
· If assigned; Global Representative for a single or multiple studies, collaborating with key stakeholders to achieve proactive, strategic and tactical success throughout the study planning, execution, and closeout phases leading to World Class clinical trials.
· If assigned; Responsible for remote data review of assigned sites/studies according to the Integrated Data Review Plan (IDRP), Monitoring Plan, SOP/WI and in accordance with the study timelines and objectives. Provides feedback on investigators/sites on an on-going basis based on the site performance. Interacts and builds professional and collaborative relationships with peers and site monitors.
- Education: Bachelors or equivalent degree, health related (e.g. Medical, Scientific, Nursing, Pharmacy) preferred.
- Site Monitoring Experience: Minimum 5 years.
- Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives and drive smart decision making.
- Excellent interpersonal skills with the ability to communicate persuasively and with clarity, flexibility and adaptability to changing requirements, resourcefulness and creativity.
- Demonstrated proactive and positive team player.
- Exhibits strong planning and organizational skills and high level of flexibility in a dynamic environment with competing projects and deadlines.
- Demonstrated business ethics and integrity.
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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