北京招聘

Job Overview:

The Senior Clinical Trial Associate will have a strong knowledge of Clinical Operations and the CTA role with the capacity to train and mentor fellow CTAs. Will support and work closely with the global project team including internal and external customers and suppliers through all phases of the study. Duties may include coordination and participation in study meetings, binder creation oversight, tracking, scanning, copying and creating, collecting, maintaining and QC of essential documents and Trial Master Files. Meets defined chargeability expectations for position.

Job Duties and Responsibilities:

Includes all duties of a Clinical Trial Associate as well as:

? Mentors and trains CTAs

? Supports and conducts site feasibility and site information collation in coordination with assigned project staff

? Assists with development of study specific forms, questionnaires and study aids.

? Supports creation of study specific SMS Plan and TMF Specification. Updates and maintains as needed

? Leads and performs start up pack document distribution, collection and quality review

? Performs regular CRA and / or site contact regarding TMF document collection and maintenance

? Coordinates, prepares and distributes the Investigational Product Release packets

? Establishes study specific site binder Table of Contents, oversees creation, reviews quality and ensures timely distribution of all site binders

? Interfaces with local and central vendors

? Performs ongoing QC of documents filed in the eTMF

? Works with Team Lead to develop applicable tools, templates and processes for the collection of study documents

? Tracks documents and study status in applicable tracking systems

? Processes IND/IDE Safety Letters, as required

? Distributes study documents to sites and study team throughout the duration of the study

? Tracks and reports all applicable project statuses to project team and sponsor

? Escalates issues to SMS Team Lead, CTM and PM as applicable

? Attends and participates in internal and sponsor team meetings. Provides department updates.

? Provides proactive support to the team communicating process improvement suggestions as applicable.

? Communicates project status and provides associated reports to the project team as appropriate.

? Assists in the retrieval and resolution of issues with transmittals.

? Scans and copies project documentation inclusive of, but not limited to, essential documents, CSAs, CRFs, and DCFs.

? Copies, collates and produces study binders.

? Reviews deliverable to ensure accuracy of content and materials copied.

? Organizes study documents and materials in compliance with Project and/or Sponsor SOPs regarding regulatory documentation as appropriate.

? Archives study documentation and returns TMF to sponsor, as directed.

? Reports all document collection and tracking issues to SMS Team Lead and/or project team on a regular basis.

? Establishes and maintains QC of the Trial Master File in accordance with project, organisational and regulatory requirements.

? Files according to Clinipace SOPs and/or Sponsor requirements along with Clinipace quality standards and adhere to 98% accuracy across the major files sections and the documents contained therein.

? Forwards correspondence to sites, sponsors and project teams as needed.

? Procures, stores, and ships study supplies.

? Interfaces with vendors as required for a project.

? Participates in internal and external team meetings, taking minutes and providing status updates as required.

? Provides support to the team communicating process improvement suggestions as applicable.

? Resolves administrative issues on behalf of the Project Manager.

? Professionally represents Clinipace in external meetings and regulatory inspections/audits.

? Maintains project server and portal where applicable.

? Proactively identifies, manages, escalates (as needed) and resolves site issues effectively and independently.

? Provides support to Project Team and assume additional roles on the team as necessary.

? Other duties as assigned by SMS Team Lead, Project Manager, SMS Director and per project-specific requirements

Supervisory Responsibilities:

No supervisory responsibilities.

Job Requirements:

? Education

o College/University graduate preferred, healthcare or life science degree a plus.

o Equivalent clinical operations experience considered

? Experience

o Prior work experience of at least one-year as a CTA or other relevant clinical operations experience.

? Skills/Competencies

o Strong English language written and verbal communication skills.

o Strong interpersonal skills.

o Team-oriented and a strong team player.

o Strong computer skills, including Microsoft Office.

o Interest in learning medical terminology.

o Exceptional attention to detail.

o Highly organized.

o Able to work in a dynamic, changing environment.

o Demonstrates honesty, trust, fairness, cooperation, self- control, and flexibility.

o Ability to work and perform tasks independently.

Clinipace Clinical Research，一个基于科技的全球性全方位服务的数字化合同研究组织（dCRO）。我们开创性的开发了依靠技术创新的CRO服务模式，以满足风险投资支持的，中型的战略性制药，生物技术公司以及医疗器械公司的研发需求。

借助于我们专有的TEMPO?电子化临床试验平台，我们的专家团队用他们丰富的治疗领域知识和见解来帮助生命科学公司制定和执行注册策略，临床开发和上市后研究，以确保药物和医疗器械开发计划的成功。

Clinipace的***目标就是通过开拓创新的技术继续坚定不移地致力于客户的成功，以最具性价比的全球性解决方案服务客户，提供高透明度，灵活和高质量的服务。

我们已经开展了超过1500个全球性的临床研究，完成了超过300个注册和开发策略制定项目。治疗领域涵盖如心血管和代谢，中枢神经系统，皮肤，消化，免疫，感染，***，肿瘤，呼吸，风湿和疫苗（和其他细胞和组织疗法）。

Clinipace刚刚庆祝了他们的10周年。如今，Clinipace其总部设在美国北卡罗莱纳州的Research Triangle Park，为横跨4大洲的27个国家提供服务。

因为对更高的数据准确度，经济高效的解决方案和更低的研发成本的需求在不断的增加，Clinipace还在持续的在全球扩张。

最后, Clinipace以正直透明、追求卓越绩效的企业文化邀请您的加入.

公司主页：*************************

最后, 丘以思以正直透明、追求卓越绩效的企业文化邀请您的加入.
应聘邮箱：kding@clinipace.com