高级临床试验专员（高级CTA）
Senior Clinical Trial Associate (Sr. CTA)
我们是谁：MapLight Therapeutics 是一家临床阶段的生物科技公司，专注于中枢神经系统疾病药物的发现。我们结合包括光遗传学、在体生理学和空间转录组学在内的前沿技术，以识别新的药物靶点并开发有效的治疗方法来应对精神症状。
你将负责：
高级临床试验专员（Sr. CTA）需要协助支持临床运营和项目团队。该职位责任重大，有机会参与临床项目的各个阶段。该职位要求具备适应能力，能够“承担”任务，解决问题，并将工作从头到尾完成。
职责：
- 直接与临床团队（如CRAs、试验经理）、站点工作人员、供应商（美国及全球范围内，视需要而定）互动，为项目特定任务和临床试验的整体管理提供支持
- 在运营负责人、临床负责人和临床试验经理的指导下直接支持。具体职责包括：
- 维护和管理研究系统用户的访问请求和停用
- 根据需要协调材料（如PowerPoint演示文稿、模板、待处理的关键文件清单等），用于内部和外部会议，包括来自外部顾问、供应商等的材料请求
- 分发安全警报和相关文件（如需要）
- 维护和更新研究团队和供应商的联系信息
- 协助计划、组织和执行特定研究的会议，撰写并分发议程、会议纪要和定期更新
- 可能参与审查、格式化和最终确定与研究相关的模板、计划和手册
- 协助维护临床试验保险
- 协助处理临床研究组织（CRO）/研究团队的问题、事项或请求，并将其转交给组织内相应人员进行解决
- 可能根据需要参与临床数据审查
- 对试验主文件（TMF）中管理的文档完整性负责；持续审查TMF以确保文档文件的质量和符合SOP及ICH GCP指南
- 转交、跟踪和归档临床文件。可能对站点的临床监管文件进行初步/持续审查，确认完整性和跟踪日期，并分发给相应的团队成员进行审查
查看英文原文
Who We Are: MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. We combine cutting-edge technologies including optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets and develop effective therapies to address psychiatric symptoms.
What You’ll Do:
The Senior Clinical Trial Associate (Sr. CTA) is required to help support Clinical Operations and project teams. The position offers much responsibility and the opportunity to be involved in all phases of the clinical project. The position requires adaptability and the capacity to ‘own’ tasks, problem solve and to see activities through to their end.
Responsibilities:
- Interact directly with Clinical (e.g., CRAs, trial managers), site staff, vendors (U.S. and worldwide, as necessary), to provide support in project-specific tasks and the overall management of clinical trials
- Directly support under the guidance of Operational Leaders, Clinical Leaders, and Clinical Trial Managers. Specific responsibilities include:
- Maintain and manage requests for access to and deactivation of study systems users.
- Coordinates materials (PowerPoint presentations, templates, outstanding essential document listing, etc.) as needed for internal and external meetings, including requests for materials from external consultants, suppliers, etc.
- Distribute safety alerts and relevant documents, if required
- Maintain and update study team and vendor contact information
- Assist in the planning, organizing and execution of study-specific meetings and write and distribute agendas, minutes and regular updates
- May participate in reviewing, formatting and finalizing study-related templates, plans and manuals
- Assist with maintaining clinical trial insurance
- Assist with questions, issues or requests from the Clinical Research Organization (CRO)/study team and route to the appropriate individual within the organization for resolution
- May participate in clinical data review, as required
- Responsible for the completeness of documents managed in the Trial Master Files (TMF); performs ongoing reviews of TMF to assure quality of the documentation files and compliance with SOPs and ICH GCP Guidelines
- Route, track and file Clinical documents. May conduct initial/ongoing review of site Clinical regulatory documentation to confirm completeness/track dates and distribute to appropriate team members for review
- Develop and maintain study-related trackers that will support Clinical Operations and individual studies. May analyze or update data associated with the trackers
- Other duties as assigned to support Study Team Leads and Operational Team Leads
Qualifications:
- Bachelor’s degree in a relevant subject area is highly recommended or a combination of education and applicable job experience may be considered.
- Minimum 2+ years in the biotech /pharmaceutical industry /clinical trial management area
- Competency of the drug development process with knowledge of ICH-GCP is a plus
- Strong interpersonal, organizational and planning skills along with excellent verbal and written communication skills
- Proactive and self-starter with the ability to take responsibility for tasks and execute seamlessly. Be able to identify areas for efficiency across studies in the spaces that the position is responsible for.
Travel:
· Ability to travel up to 35%
MapLight does not accept unsolicited resumes from recruiters, staffing agencies, or search firms.
Compensation for this role may vary within the above range based on many factors including geographic location, candidate experience, and skills. Additional compensation/benefits include annual bonus opportunity, medical, dental, vision, life and AD&D, short term and long term disability, 401(K) plan with match, stock options, flexible non-accrual paid time off, and parental leave.
Salary Range
$115,000—$130,000 USD
EEOC Statement: MapLight Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
Originally posted on Himalayas