临床研究系统研究构建专员
Clinical Research Systems Study Build Specialist
Alcanza是一家正在快速发展的多站点、多阶段的临床研究公司，在马萨诸塞州、新罕布什尔州、密歇根州、弗吉尼亚州、南卡罗来纳州、佛罗里达州、佐治亚州、阿拉巴马州、密苏里州、田纳西州、德克萨斯州和波多黎各设有多个地点。我们在I-IV期研究以及疫苗、神经学、皮肤科、精神病学和普通医学等多个治疗领域建立了强大的影响力。随着公司持续发展，我们诚邀您的加入。
临床系统研究构建专家将负责在临床试验管理系统（CTMS）中为Alcanza临床研究站点网络创建和维护财务研究构建。向临床系统研究构建经理（或其代表）汇报，该职位将管理新构建和修改请求的工单系统，与运营和财务同事合作确定研究构建的优先级，并按照研究方案及时完成构建。该职位是Alcanza研究启动流程的重要组成部分，也是记录收入并及时获得服务资金的关键。
关键职责
核心工作职责：
- 按照研究方案、合同条款和Alcanza研究构建指南，在CTMS系统中完成高质量的临床研究构建。
- 与内部团队协作，确保计费决定、赞助商预算和临床试验协议符合临床试验方案和站点要求，以捕捉所有可能的收入。
- 与运营和财务同事合作，执行质量控制流程，确保研究构建的完整性并最大化未来的现金流。
- 识别临床试验协议中未明确的任何要求，并与运营和财务负责人合作，确保合同义务得到履行。
- 与运营、预算/合同、系统和财务同事合作，以可扩展的方式实施最佳实践。
- 积极参与特殊项目，包括但不限于流程标准化、系统迁移、系统集成（如CTMS和eSource）以及新收购站点流程和系统的整合，根据需要进行。
- 识别改进业务流程和效率的机会。
- 维持积极、结果导向的工作环境，建立团队内部及整个组织内的合作关系，树立团队合作的榜样。
- 完成其他可能被要求或指派的任务。
技能、知识和专长
最低资格
查看英文原文
Alcanza is a growing multi-site, multi-phase clinical research company with a network of locations in MA, NH, MI, VA, SC, FL, GA, AL, MO, TN, TX and Puerto Rico. We have established a strong presence across Phase I-IV studies and several therapeutic areas including vaccine, neurology, dermatology, psychiatry, and general medicine. Join us as we continue to grow.
The Clinical Systems Study Build Specialist will be responsible for the creation and maintenance of financial study builds in the Clinical Trial Management System (CTMS) for the Alcanza Clinical Research site network. Reporting to the Clinical Systems Study Build Manager (or their delegate), the candidate will manage a ticketing system of requests for new builds and revisions, partner with Operations and Finance colleagues to prioritize study builds, and complete builds timely and in accordance with the study protocol. This position is a crucial contributor to Alcanza’s Study Startup process and ability to record revenue and receive timely funding for its services performed.
Key Responsibilities
Essential Job Duties:
- Complete high-quality Clinical study builds in the CTMS system(s) in accordance with the study protocol, contract terms, and Alcanza study build guidelines.
- Collaborate with internal teams to ensure billing determinations, sponsor budget, and clinical trial agreement are congruent with the clinical trial protocol and site requirements to capture all possible revenue.
- Enforce a Quality Control process with Operations and Finance colleagues to maintain integrity of the study build and maximize future cash flow.
- Identify any protocol requirements not identified in Clinical Trial Agreement and collaborate with operation and financial leads to ensure contractual obligations are met.
- Partner with Operations, Budgets/Contracts, Systems, and Finance colleagues to implement best practices in a scalable manner.
- Active participation in special projects, including but not limited to process standardization, system migrations, system integrations (e.g. CTMS and eSource) and integration of newly acquired sites’ processes and systems, as needed.
- Identify opportunities to improve business processes and efficiencies.
- Maintain a positive, results oriented work environment, building partnerships within the team and across the organization at large, modeling teamwork.
- Perform all other duties that may be requested or assigned.
Skills, Knowledge and Expertise
Minimum Qualifications: Bachelor’s degree in accounting, finance, business, sciences or related field preferred (associate degree required) AND 2+ years of clinical research industry experience, OR an equivalent combination of education and experience. Experience entering calendar details, study budget elements and financials into a CTMS system is required. Experience with clinical conductor required. Required Skills:
- Proficiency with computer applications such as Microsoft applications, email, electronic health records, and web applications and the ability to type proficiently (40+ wpm).
- Strong organizational skills, time management, attention to detail, and math proficiency.
- Well-developed written and verbal communication skills .
- Well-developed interpersonal and listening skills and the ability to work independently as well as with co-workers, subjects, managers, and external customers.
- Ability to effectively manage multiple tasks and adapt to changes in workloads and priorities.
- Ability to be professional, respectful of others, self-motivated, and exemplify a strong work ethic.
- A high degree of integrity and dependability.
- Ability to work under minimal supervision, identify problems and implement solutions.
- Ability to handle highly sensitive information in a confidential and professional manner, and in compliance with privacy and company guidelines.
Benefits
- Full-time employees regularly scheduled to work at least 30 hours per week are benefits-eligible, with coverage starting on the first day of the month following date of hire.
- Medical, dental, vision, life insurance, short and long-term disability insurance, health savings accounts, supplemental insurances, and a 401k plan with a safe harbor match are offered.
Originally posted on Himalayas