上海招聘

职责描述：

1. Marketing Duties and Responsibilities

？ -Networks with peers in the medical device industry.

？ -Informs manager or marketing colleagues of potential opportunities.

2. Role-Specific Duties and Responsibilities

？ -Informs MRM of challenging and/or noncompliant investigators/staff.

？ -Supports data management in CRF development, validation rules, UAT, and other reporting/analysis tasks.

？ -Supports the MRM in managing all aspects of a CEC/DSMB.

？ -Reviews and suggests content for clinical SOPs

？ -Conducts remote monitoring visits including, initiation, interim and close-out visits as required per study monitoring plan.

？ -Provides input to the site selection process on appropriate/inappropriate sites.

3. External MRA (eMRA)

？ -Independently performs investigational site qualification, interim and site close-out monitoring visits in accordance with NAMSA Standard Operating Procedures. Completes and writes applicable visit report and follow-up letter. Independently performs site initiation visits including conducting site and study specific training in accordance with NAMSA Standard Operating Procedures. Writes site initiation visit report and follow-up letters. Responsible for collecting and completing associated documentation during visit.

？ -Addresses and closes (whenever possible) site issues/monitoring action items during onsite visits.

？ -Reviews clinical data for completeness, clarity and conflicts. Issues data queries as needed to resolve inconsistencies or obtain additional information during onsite visits.

？ -Reviews Investigator Site Files during onsite visits in accordance with NAMSA Standard Operating Procedure and study monitoring plan. Collects documents for internal site files as needed.

？ -Instructs and educates site personnel on requirements for CRF completion, source documentation, GCP, study protocol, study file management, device management, maintaining blinding, etc. during onsite visits.

？ -Performs clinical device or biologic inventory and accountability per NAMSA Standard Operating Procedure and study monitoring plan.

？ -Responsible for ensuring compliance with all monitoring plan requirements

？ -Responsible for ensuring accuracy, completeness, and timeliness of visit reports, confirmation/follow-up letters.

？ -Responsible for ensuring accuracy and quality of collected documents and timely submission of these documents into the trial master file.

？ -Communicates with investigators during site visits, and via follow-up letters to inform of any issues as well as good performance.

？ -Identifies data trends during onsite visits and effectively communicates trends to iMRA and MRM and site study personnel as appropriate.

？ -Communicates with iMRA (as applicable) on site specific items.

？ -Per Sponsor request, develops monitoring requirements presentation and attends Investigator Meeting.

？ -Travels as needed (typically between 30%-60%) to meet project milestones.

？ -Performs role of iMRA as needed.

4. Internal MRA (iMRA)

？ -Conducts search for potential clinical investigators, performs pre-site assessment.

？ -Creates feasibility questionnaire for potential clinical investigators.

？ -Serves as primary site contact for clinical trial needs, including addressing protocol and GCP questions, ensuring supply of study materials and devices.

？ -Coordinates IRB/EC/REB submissions.

？ -Ensures a site is prepared for initiation, including support with contract negotiation, informed consent review and collection of essential documents.

？ -Performs site-specific training as needed (outside of SIV) and completes necessary documentation.

？ -Tracks and performs quality review of all study documents required for site activation. Completes and distributes site activation letter following verification of required documentation.

？ -Owns quality and completeness of central and site master files. Tracks and maintains required study documents, performs quality control review, manages renewals, and follows up directly with site personnel to instruct and educate as needed. Has oversight of CTMS development.

？ -Maintains internal records to track clinical device or biologic inventory.

？ -Has direct site communication including regular communication and follow-up on study activities including but not limited to queries, monitoring action items, PI eCRF signatures, data entry completeness, subject follow-up visits, expired documents, etc.

？ -Tracks clinical project metrics.

？ -Supports internal review of data according to the centralized data monitoring plan in conjunction with data management.

？ -Supports the MRM in Investigator Meeting content, logistics and materials development.

？ -Summarizes clinical data trends and metrics for varied audiences.

？ -Performs role of eMRA as needed, including traveling as needed (typically＜10%)

？ -Creates and contributes to development of study tools and materials (e.g. project specific work instructions, newsletters, calendar wheels, inclusion/exclusion cards, tip cards, etc.).

任职要求：

1. Fluency in English and local language, if different, required.

2. Bachelor’s degree or equivalent experience in a related field, with a minimum 2 years of current monitoring (preferred) and relevant clinical trial experience.

3. Knows and functions under Good Clinical Practices.

5. Familiar with clinical trial processes such as site selection/qualification, site initiation, monitoring, and close-out.

6. Familiar with clinical data reporting process.

7. Ability to effectively communicate with physicians, health care workers, study coordinators, IRB/EC/REB personnel (and to persuade them to do what is needed).

        NAMSA建立于1967年，至今已经有50余年的历史，是全球医疗器械安全性和有效性研究领域中公认的先驱。早在美国FDA 1976年对医疗器械建立比较完整的监管法规之前，就在美国市场中为科学家对医疗器械安全性和有效性研究提供各种实验室测室测试研究服务。

        如今NAMSA为医疗器械厂商提供全程产品开发研究、风险管理、和质量管理的实验室数据测试、临床研究计划实施和 法规的咨询服务。服务的领域涉及几乎所有医疗器械产品，例如心血管、骨科、眼科、牙科、诊断试剂等等。

        在全球医疗器械安全研究领域，NAMSA始终处于学术的最前沿。很多研究成果被全球标准组织采纳，作为各国医疗器械安全监管的基础。

NAMSA is a medical research organization providing expert regulatory, laboratory, clinical, and compliance services to medical device and healthcare product manufacturers. At every stage of the product development process, we provide strategic guidance and tactical support to help clients commercialize medical products in the major markets of the world.

We serve as your trusted partner, using our insight to identify strategies for saving time, while never compromising quality. We know that compromised quality can quickly take your product right back to the starting line. That’s why it’s so important to have a smart strategy from the outset—and why we put it at the forefront of every project.

The path to regulatory approval can be long and complex. We provide a reliable way to get there.