高级临床研究经理（神经病学）
Sr. Clinical Research Manager (Neurology)
神经科部门正在寻找一名高级临床研究经理。约翰霍普金斯大学的研究人员进行临床试验和临床研究，以发现预防和治疗疾病及其他健康问题的新方法。高级临床研究经理与首席研究员合作，确定研究方向，并负责临床试验组合和临床研究活动的整体管理。计划并指导临床研究操作，通常涉及外部合作伙伴和内部合作者，以及国家和国际网络。负责管理研究员工，制定并实施有效的数据管理和法规程序，为研究员工提供教育，并确保研究员工得到适当的培训。
具体职责与任务
- 与研究者合作，并在研究进行中独立判断并指导其开展
- 参与与合作者、首席研究员和资助机构的科学讨论，并对影响研究开展的决策做出贡献
- 负责项目内临床研究协调员和法规人员的招聘、教育、培训和监督
- 负责制定并实施项目内的临床研究政策和流程
- 在所有相关人员之间促进有效协作，例如研究员工、研究护士、数据管理人员、法规人员、医院员工等
- 确保在整个生命周期内负责任地执行临床研究方案，包括开发、实施、维护和终止
- 与首席研究员合作进行研究方案的开发和评估，包括审查和评估新方案的清晰度、全面性、财务和后勤可行性，确保受试者安全等
- 监督向伦理委员会提交的准备和提交工作，并代表首席研究员处理法规相关事宜
- 跟踪并监督法规审批过程，确保研究高效启动；协助法规员工处理由研究者发起的研究的知情同意书和方案修订
- 管理临床研究预算的生成和项目的财务管理
- 确保合理使用集中资源并适当遵守相关政策，例如临床试验管理系统、前瞻性报销分析等
- 分析
查看英文原文
The Department of Neurology is seeking a Sr. Clinical Research Manager. Researchers at Johns Hopkins University conduct clinical trials and clinical studies to discover new ways to prevent and treat diseases and other health problems. The Sr. Clinical Research Manager works in collaboration with PI(s) to set the direction for research and is responsible for the overall management of a clinical trials portfolio and clinical research activities. Plans and directs clinical research operations which typically involves external partners and internal collaborators, and/or national and international networks. Responsible for managing research staff, developing and implementing effective data management and regulatory procedures, providing education to research staff, and ensuring research staff are properly trained.
Specific Duties & Responsibilities
- Collaborate with investigator(s) and exercise independent judgement in directing the conduct of the research
- Participate in scientific discussions with collaborators, PI's, and funding organizations and contribute to decisions impacting conduct of research.
- Responsible for the recruitment, education, training and supervision of the clinical research coordinators and regulatory personnel within the program.
- Responsible for development and implementation of policy and procedures for clinical research within the program.
- Facilitate effective teamwork among all involved personnel, e.g. research staff, research nursing, data management, regulatory personnel, hospital staff, etc.
- Ensure responsible conduct of clinical research protocols throughout the lifecycle, including development, implementation, maintenance, and termination.
- Collaborate with PIs on research protocol development and evaluation, including reviewing and assessing new protocols for clarity, thoroughness, financial and logistical feasibility, maintaining subject safety etc.
- Oversee preparation and submissions to IRB and act as liaison for regulatory issues on behalf of the PI.
- Track and oversee the regulatory approval process to ensure efficient study startup; assist regulatory staff with informed consent and protocol amendments for investigator-initiated studies
- Manage clinical research budget generation and financial management of the program.
- Ensure efficient use of centralized resources and adherence to policies as appropriate, e.g. clinical trial management system, prospective reimbursement analysis, etc.
- Analyze resource utilization by individual trials to ensure research needs are anticipated and met.
- Ensure adequate system for tracking and reporting clinical research milestones for financial invoicing.
- Ensure the development, testing, and evaluation of manuals, questionnaires, and coding structures for the efficient collection of data.
- Ensure research staff maintain complete and accurate research data and charts and are well prepared for auditing and monitoring visits.
- Lead study meetings to examine data, decide on next steps, implement changes to protocol operations based on results and goals, and initiate sub-studies.
- Contribute to manuscripts and presentations.
- Other duties as assigned.
Minimum Qualifications
· Bachelor's Degree in a related field.
· Six years of related experience in clinical research in an academic, government, or pharmaceutical industry environment.
- Demonstrated supervisory or lead experience.
- Advanced knowledge of GCP/ICH and local regulations.
- Additional education may substitute for required experience and additional related experience may substitute for required education beyond a high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula.
Preferred Qualifications
· Master's Degree in a related field.
· Certification as a Clinical Research Professional.
· Formal project management training or certification.
Technical Skills & Expected Level of Proficiency
- Budget Management - Advanced
- Clinical Resource Knowledge - Advanced
- Data Management and Analysis - Advanced
- Good Clinical Practices - Advanced
- Finance Project Management - Advanced
- Oral and Written Communications - Advanced
- Program Development - Advanced
- Record Keeping - Advanced
- Regulatory Compliance - Advanced
- Resource Management - Advanced
- Strategic Program Management - Advanced
The core technical skills listed are most essential; additional technical skills may be required based on specific division or department needs.
Classified Title: Sr. Clinical Research Manager
Role/Level/Range: ACRP/04/ME
Starting Salary Range: $64,600 - $113,300 Annually ($89,000 targeted; Commensurate w/exp.)
Employee group: Full Time
Schedule: M-F 8:30 am - 5:00 pm
FLSA Status: Exempt
Location: Remote
Department name: SOM Neuro BIOS
Personnel area: School of Medicine
Originally posted on Himalayas