临床研究可行性协调员
Clinical Research Feasibility Coordinator
Alcanza是一家正在快速发展的多站点、多阶段的临床研究公司，在阿拉巴马州、亚利桑那州、佛罗里达州、佐治亚州、伊利诺伊州、马萨诸塞州、密歇根州、密苏里州、内华达州、弗吉尼亚州、南卡罗来纳州、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，我们期待您的加入。
Feasibility Coordinator负责处理所有站点的临床研究可行性，并支持业务发展团队的需求。
关键职责
主要工作职责：包括但不限于以下内容：
- 根据申办方/临床研究组织（CRO）的要求，按照既定时间表完成可行性评估。
- 审阅并理解可用的研究详情，如方案或方案概要，以进行可行性评估。
- 识别将与业务发展团队合作开展临床研究试验的潜在研究者。
- 联系潜在研究者/临床站点负责人，讨论研究细节和方案，以评估拟议研究的可行性。
- 维护站点能力的文档，包括特定于FQs（如MRI、PET、CSF等）的设备清单。
- 将填写好的问卷和相关文件归档到CRM中。
- 按照可行性流程提交可行性问卷。
- 根据需要持续更新可行性信息。
- 将每位患者的预算金额输入系统。
- 定期将PI信息输入申办方、CRO和其他类似数据库。
- 在需要时作为备份完成并获取保密协议的签署。
- 协助管理即将开展的研究试验流程。
- 在业务发展团队的协助下申请新研究。
- 参加并顺利完成所有公司培训项目；根据需要参加网络研讨会和其他会议。
- 根据需要参加团队、部门、客户及其他会议。
- 以及时且专业的方式与客户和所有利益相关者（内部和外部）沟通和协作。
- 保持患者、客户和公司信息的机密性。
- 执行所有其他要求或指派的任务。
技能、知识和专长
最低资格要求：高中毕业或同等学历，并具备2年以上行政、销售支持或类似工作经验
查看英文原文
Alcanza is a growing multi-site, multi-phase clinical research company with a network of locations in AL, AZ, FL, GA, IL, MA, MI, MO, NV, VA, SC, 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 Feasibility Coordinator is responsible for processing clinical research feasibilities for all sites and supporting the needs of the Business Development team.
Key Responsibilities
Essential Job Duties: Responsibilities include, but are not limited to, the following:
- Complete feasibility in accordance with set timelines per sponsor/Clinical Research Organization (CRO) requirements.
- Review and understand the available study details such as protocol or protocol synopsis for the conduct of the feasibility.
- Identify the potential investigators at sites who will be conducting the clinical research trial in conjunction with Business Development Team.
- Contact potential investigators/clinical site leaders to discuss study details and protocol in order to assess the feasibility of the proposed study.
- Maintain documentation as to sites capabilities, including lists of equipment specific to FQs (i.e.: MRI, PET, CSF, etc.).
- File filled questionnaires and relevant documents into CRM.
- Submit feasibility questionnaires in accordance with feasibility process.
- Update feasibility on an ongoing basis as needed.
- Add per patient budget amounts into systems.
- Input PI information into Sponsor, CRO and like databases on a regular basis.
- Back-up for completing and obtaining signatures for confidential agreements as required per sponsor or CRO.
- Assist in the management of the upcoming research trials pipeline.
- Aid in applying for new studies in conjunction with Business Development Team.
- Attend and successfully complete all company training programs; participate in webinars and other meetings as needed.
- Participate in team, department, client, & other meetings as needed.
- Communicate and work with clients and all stakeholders (internal & external) in a timely and professional manner.
- Maintain confidentiality of patients, customers, and company information.
- Perform all other duties as requested or assigned.
Skills, Knowledge and Expertise
Minimum Qualifications: A high school diploma or equivalent AND 2+ years of administrative, sales support, or similar experience, OR an equivalent combination of education and experience, is required. 1+ years of clinical research experience is required. Prior experience with the feasibility process in a clinical research setting is highly preferred. Bi-lingual (English / Spanish) proficiency is a plus.
Required Skills:
- Proficiency with computer applications such as Microsoft applications, email, electronic health records, web applications, and the ability to type proficiently (40+ wpm);
- Performing basic clinical procedures such as blood pressure, vitals, EKGs, phlebotomy, etc.
- Strong organizational skills and attention to detail.
- Well-developed written and verbal communication skills.
- Well-developed interpersonal and listening skills and the ability to work well independently as well as with co-workers, subjects, managers and external customers.
- Ability to effectively handle multiple tasks, and adapt to changes in workloads and priorities.
- Must be professional, respectful of others, self-motivated, and have a strong work ethic.
- Must possess 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 HIPAA 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