南京招聘

PURPOSE
To provide medical, clinical, and scientific advisory expertise to all QTRN divisions as requested.
The Associate Director participates in all aspects of Medical and Scientific Services' involvement on assigned trials. Provides
leadership, management and direction to assigned staff. Assists in the implementation of department mission, goals and
objectives, oversight of operations, development of policies and procedures and standards for the department.
RESPONSIBILITIES
? Serves as Regional Medical Advisor on assigned projects.
? Provides medical support to investigative sites and project staff for protocol-related issues including protocol
clarifications, inclusion/exclusion determinations, and issues of patient safety and/or eligibility.
? Performs review and clarification of trial-related Adverse Events (AEs).
? Performs medical case review of Serious Adverse Events (SAEs), including review of case documentation and patient
narrative.
? Provides medical support for the Analysis Of Similar Events (AOSE).
? Performs medical review of Adverse Event coding.
? Performs medical review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs).
? Performs review of the Clinical Study Report (CSR) and patient narratives.
? Available 24 hours per day, 7 days per week to respond to urgent protocol-related issues at the investigative sites.
? Attends and presents at Investigator Meetings.
? Provides therapeutic area/indication training for the project clinical team.
? Attends Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested.
? Serves as Scientific Advisor and provides guidance to Project Managers on the medical and scientific aspects of
assigned projects.
? Provides support to the proposal development team which may include, but is not limited to, reviewing the protocol for
feasibility, giving guidance as to anticipated enrollment, and general advice as to the various risks associated with
running a particular study.
? Participates in development of Medical and Scientific Services portion of client proposals including the budgeting
process.
? Serves as a resource, and may participate in strategic business development activities including presentations to
prospective clients, professional meetings, and other business development activities for Medical & Scientific Services.
All responsibilities are essential job functions unless noted as nonessential (N).
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
? Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research including knowledge of
regulations and guidelines pertaining to regulatory affairs
? Ability to establish and meet priorities, deadlines, strategic department goals and objectives
? Skills in providing consultation and advice on multiple assignments required, as well as initiative and flexibility
JOB DESCRIPTION
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? Ability to establish and maintain effective working relationships with coworkers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
? A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general
medical education, along with a medical license, or equivalent, from the country or region in which he/she resides and
works is required, plus a minimum of 5 years experience in clinical medicine, in addition to 2 years clinical trials
experience as an investigator or in the Pharma, CRO, or Biotech industry. Specialty Board certification desirable; or
equivalent combination of education, training and experience
PHYSICAL REQUIREMENTS
? Extensive use of telephone and face-to-face communication requiring accurate perception of speec.
? Extensive use of keyboard requiring repetitive motion of fingers.
? Regular sitting for extended periods of time.
? Frequent travel.

    昆拓信诚医药研发（北京）有限公司是艾昆纬公司投资全资子公司，为美资CRO公司，依托艾昆纬公司全球高标准的质量管理系统和资源，昆拓形成了涵盖所有运营部门的完备标准操作流程（SOP）系统以及质量控制体系。
    昆拓秉承诚信、责任、合作、创新的公司文化，致力于成为中国本土临床研究服务的领跑者，以艾昆纬为依托，用心提供高品质的专业化服务。昆拓具有开放、友好的公司文化氛围，制定了严格的人才培养机制，为员工提供了良好的培训以及职业发展平台。
    人员一经录用，公司将提供富有竞争力的薪酬水平。除去国家规定的五险一金外，公司还给员工提供商业医疗保险和商务旅行保险、年度体检、重大疾病保险及人身意外保障等。