临床研究经理
Clinical Research Manager
神经病学系正在寻找一名临床研究经理，负责在全国20多个临床站点中执行和组织工作计划，以支持BIOS临床试验协调中心（CTCC）的临床试验研究目标。
约翰霍普金斯大学的研究人员开展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。临床研究经理在Pl（项目负责人）的总体监督下，负责管理复杂临床方案或多项研究和/或多个站点的行政和科学实施。作为研究团队的一部分，与教职员工合作，制定方案，制定标准操作规程，并监督一项或多项研究的相关活动。负责资助申请和管理以及监管合规性。监督或管理其他非豁免级别的研究员工；可能监督本地或多中心站点的员工。
具体职责与任务
- 与研究者合作，并在代表Pl的情况下独立判断地管理研究的进行。
- 参与与合作者、Pl及资助机构的科学讨论。
- 与Pl合作，确保所提议的方案/研究设计的运营可行性。
- 制定或监督制定标准操作规程和数据收集表单。
- 制定或监督制定基于方案的临床试验知情同意书。
- 监督向IRB提交材料，并作为Pl的首要联络人处理监管合规问题。
- 对研究数据管理和监管问题进行培训和监督。
- 与商业机构和/或政府机构的赞助方合作，确定哪些群体可以考虑患者人群、可用资源和提供服务的成本。
- 与财务团队合作制定研究预算，并确保所有研究成本都包含在预算中。
- 确保临床研究方案已完成前瞻性报销分析（PRA），并建立系统以确保在需要时遵循PRA。
- 确保有完善的系统用于跟踪和报告临床研究里程碑，以便财务开票。
- 监控活动、系统和流程，以增加转诊人数并提高临床试验的入组率。
- 确保手册、问卷等的开发、测试和评估。
查看英文原文
The Department of Neurology is seeking a Clinical Research Manager who will deliver and organize work plans with 20+ clinical sites across the country in support of clinical trial research goals of the BIOS Clinical Trials Coordinating Center’s (CTCC).
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 Clinical Research Manager works under the general supervision of a Pl(s) to manage the administrative and scientific implementation of a complex clinical protocol or multiple studies and/or multiple sites. As part of a study team, collaborate with faculty, develop protocols, develop SOPs, and supervise study-related activities for one or more studies. Has accountability for grant submission and administration and regulatory compliance. Supervise or oversee other exempt level research staff; may oversee staff at local or multi-center sites.
Specific Duties & Responsibilities
- Partner with investigator(s) and exercise independent judgement in managing the conduct of the research on behalf of the Pl.
- Participate in scientific discussions with collaborators, Pl's, and funding organizations.
- Collaborate with Pl to ensure operational feasibility of proposed protocol/study design.
- Develop, or oversee the development of standard operating procedures and data collection forms from protocol(s).
- Develop or oversee the development of consent form(s) for clinical trials based on protocol(s).
- Oversee preparation and submissions to IRB and act as primary liaison for regulatory compliance issues on behalf of the Pl.
- Train and provide oversight of research data management and regulatory issues.
- Work with commercial and/or government agency sponsors to determine what group can commit to considering patient population, available resources, and cost of providing services.
- Collaborate with the finance team to develop study budget(s) and ensure that all study costs are included in the budget.
- Ensure clinical research protocol has a completed Prospective Reimbursement Analysis {PRA) and processes/systems are in place to ensure the PRA is followed when required.
- Ensure adequate system for tracking and reporting clinical research milestones for financial invoicing.
- Monitor activities, systems, and processes to increase referrals and increase accruals to clinical trials.
- Ensure the development, testing, and evaluation of manuals, questionnaires, and coding structures, for the efficient collection of data.
- Oversee data collection at a single site or at multiple sites of a multi-centered clinical trial.
- Lead study meetings to examine data, determine next steps, implement changes to protocol operations based on results and goals, and initiate sub-studies.
- Contribute to presentations and manuscripts.
- Hire, supervise and manage performance of other exempt-level research staff.
- Other duties as assigned.
Minimum Qualifications
- Bachelor's Degree in a related field.
- Five years of related experience in clinical research in an academic,
- Strong organizational, analytical, and leadership skills with experience in multi-site coordination.
- 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.
- Advanced knowledge of GCP/ICH and local regulations.
- Proficiency in Microsoft Office Suite and SharePoint; ability to learn new software (e.g., eIRB, EDC systems).
Technical Skills & Expected Level of Proficiency
- Budget Management - Advanced
- Clinical Study Design - Advanced
- Good Clinical Practices - Advanced
- Interpersonal Skills - Advanced
- Oral and Written Communications - Advanced
- Project Management - Advanced
- Record Keeping - Advanced
- Regulatory Compliance - Advanced
- Strategic Planning - Advanced
The core technical skills listed are most essential; additional technical skills may be required based on specific division or department needs.
Classified Title: Clinical Research Manager
Job Posting Title (Working Title): Clinical Research Manager
Role/Level/Range: ACRP/04/MD
Starting Salary Range: $55,800 - $97,600 Annually ($76,700 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