CTA-临床监察助理-SH
上海日新医药发展有限公司ShanghaiUpdate time: July 19,2019
Job Description
GENERAL DESCRIPTION AND RESPONSIBILITIES:
To perform non patient related duties and provide technical/logistical support to Clinical Research Department to ensure timely and efficient initiation, management and closure of clinical trials.As country clinical supplies administrator and under office head supervision to check drug room temperature weekly and handle supplies’ shipment with completed documentationSupport the tasks below for assigned project throughout the study:
This job description does not list all duties of the job. Employees may be asked by supervisors or management to perform other duties.
MINIMUM REQUIREMENTS:
To perform non patient related duties and provide technical/logistical support to Clinical Research Department to ensure timely and efficient initiation, management and closure of clinical trials.As country clinical supplies administrator and under office head supervision to check drug room temperature weekly and handle supplies’ shipment with completed documentationSupport the tasks below for assigned project throughout the study:
- Support for Trial Master File (TMF) maintenance in accordance with ICH-GCP and SOPs (SMART-KMS scanning, indexing and QC within prescribed timelines)
- Updates the trial and site information as necessary in Clinical Trial Management System ( CTMS) –Trial Work® in a timely manner
- Attends appropriate training programs and project teleconferences as applicable.
- Support ethics committee & regulatory submissions
- Support study team to upload essential document into SMART-KMS
- Complies with EPS INTL Policies, SOPs & IGs and local regulations during various projects related transactions
- Provides back-up coverage for other CTA as necessary.
- Supports Project Leader for production and tracking of trial metrics measurements.
- Supports Project Leader for coordinating with sites for finalizing budget worksheets and contractual agreements .
- Provides support as needed for drug management and finance management.
- Maintains and ensures the availability of inventory for all non drug supplies.
- Provides logistic and administrative support to project teams.
- Responsible for distribution of SUSAR/safety letters to the sites, Ethics Committee and regulatory authority, if applicable
- Supports CRA to track study budget in country and site level as applicable.
- Provide logistic support for local PI meeting and CR related meeting/training.
This job description does not list all duties of the job. Employees may be asked by supervisors or management to perform other duties.
MINIMUM REQUIREMENTS:
- Diploma or Degree in Life-Science from a recognized institutions, and/or equivalent combination of training and experience
- Good coordination skills and ability to establish and maintain effective working relationships with all levels within the company and third parties.
- Effective time management and good ability to manage competing priorities
- Good communication skills and must be fluent in both written and spoken
- EnglishGood team player with excellent interpersonal and organizational skills
- High integrity in personality and professionalism
- Positive attitude, high degree of initiative, committed and able to work independently
- Self-initiative to perform duties, with good analytical and problem-solving capabilitiesAbility to handle multiple tasks and expected to follow through with completion of assigned tasks with minimal supervision
- Meticulous and able to work in a fast-paced environment
- Able to work under pressure and under challenging timelines when required
- Excellent computer skills and proficient in Microsoft Word, Excel and PowerPointAble to travel when required
职能类别： 医药技术研发管理人员
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上班地址：延安西路1326号生物大厦3楼
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