上海招聘

GENERAL DESCRIPTION AND RESPONSIBILITIES

A) Set up an investigator site in a timely manner
o Appropriate investigator site set-up and implementation including

o Coordinate and facilitate investigator site selection

o Conduct Pre-Study Visit

o Fully communicate with site staff about study design, product, and study timeline

o Coordinate and prepare ethics committee & regulatory submissions

o Prepare clinical trial agreements and budget plans

o Coordinate the imports of study drug, lab kits, and equipments and exports of patient’s specimen
o Initiate meeting organization
o Conduct site initiation visit, e.g. set up trial logistics, make sure the site personnel are well-trained and familiar with study procedures…etc
o Update the trial and site information in CTMS and other study management system in a timely manner including in-house administration activities

B) Site Management
o Deliver good quality data in a timely manner
o Attend CRA training, therapeutic area training, and investigator meeting
o Ensure/train site personnel to be familiar with GCP, company’s related policy and SOP, and regulatory requirements
o Conduct site contact, monitoring, and data query resolution and ensure data quality per company standard
o Protect patient’s rights and safety
o Ensure sites conducting study adhere to GCP , SOP and protocol design
o Ensure SAE reporting timeline to meet regulatory and company requirements
o IP management
o Ensure/train site personnel to document IP shipment and accountability timely and correctly
o Ensure the stock and expiry date of IP at site

C) Close investigator sites
o Appropriate investigator site close-out and implementation including
o Conduct site close-out visit
o Fully communicate with investigator about the responsibility of PI after site close-out
o Inform ethics committee & regulatory of site close-out
o Inform study team site close-out if needed

D) Build up the relationship with key partners
o Collaborate closely with study team and sponsors on clinical trial related issues
o Represent the clinical research role & objectives to both internal & external partners (e.g. investigators, KOL) to promote mutually satisfying collaborations
o Prepare and present monthly reports in monthly meeting and share experiences with internal colleagues

This job description does not list all duties of the job. Employees may be asked by supervisors or management to perform other duties.

MINIMUM REQUIREMENS

o Diploma or Degree in Life-Science from a recognized institutions, and/or equivalent combination of training and experience
o Minimum 1.5 years experience in clinical research and fundamental understanding of clinical trial procedure and the regulatory environment.
o Good coordination skills and ability to establish and maintain effective working relationships with all levels within the company and third parties.
o Effective time management and good ability to manage competing priorities
o Good communication skills and must be fluent in both written and spoken English
o Good team player with excellent interpersonal and organizational skills
o High integrity in personality and professionalism
o Positive attitude, high degree of initiative, committed and able to work independently
o Self-initiative to perform duties, with good analytical and problem-solving capabilities
o Ability to handle multiple tasks and expected to follow through with completion of assigned tasks with minimal supervision
o Meticulous and able to work in a fast-paced environment
o Able to work under pressure and under challenging timelines when required
o Excellent computer skills and proficient in Microsoft Word, Excel and PowerPoint
o Able to travel when required

* ABOUT US

EPS INTERNATIONAL CO., LTD (EPS INTERNATIONAL), a clinical service provider established by a reputable leading full service Japanese contract research organization – EPS Co. Ltd (EPS), commences its operations in 1999 to provide an integrated, seamless and optimal drug development platform through synergizing EPS’s long-established clinical resources and operations in Asia region to best support increasing outsourcing needs in the research, development and commercialization of pharmaceutical products and medical devices initiated by global and Japanese companies worldwide.
 
We have strong presence in Asia and are fast expanding our footprints in the Pacific, Europe and US.
 
Website www.epsgr.com
 
 
* COMPANY VALUES

In line with EPS’s corporate visions, EPS INTERNATIONAL aims to be an “Ever Progressing System” by continuously delivering quality clinical services, providing efficient and effective turn-key solutions for our Clients’ products development needs in Asia region.
 
 
* COMPANY SUCCESS
 
EPS INTERNATIONAL leverages and applies EPS’s values with many years of combined experiences as an added value to our Clients’ programs ranging from research, development to commercialization in key Asian countries. Lead by a great team of professionals with in-depth experiences and relationships supported by regional clinical networks, key opinion leaders and good performance sites, EPS INTERNATIONAL is the preferred outsourcing partner in Asia.

 
One of the large CRO in Japan and listed on Tokyo Nikki Stock Exchange. We are profitable and have strong and stable financial support from EPS Group.


A full service provider from Bioanalytics (Phase I) to Phase IV to Central lab, patient recruitment services, resource solution to meet clients one-stop shop needs


Strong language capabilities within the team - Japanese, Chinese & English. Known as the best Japanese study CRO service provider.

 
Our Data Management Group has a strong brand and reputation in the industry

 
Comparatively large clinical operation team with wide therapeutic area experience that spans over Asia.