ctc i
4 weeks ago
Shanghai, Shanghai, China
Thermo Fisher Scientific
Full time
Job DescriptionClinical Trial Coord
Division / Dept:
Various Reports to
Title:
Supv or Above
Job Code:
CD451
Job Family:
Clin Dev
Job Level:
A1 FLSA Status: Nonexempt
Summarized Purpose:
Provides administrative and technical support to the Project Team. Supports audit readiness by ensuring
files are reviewed on schedule detailed in the organization's WPD and department guidance document.
Essential Functions and
Other Job Information:
Essential
Functions
- According to the specific role (Central or Local), coordinates, oversees and
- Performs department, Internal, Country and Investigator file reviews as assigned
- Ensures allocated tasks are performed on time, within budget and to a high
- Supports the maintenance of study specific documentation and systems including
but not limited to:
study team lists, tracking of project specific training
requirements, system access management, and tracking of project level activity
plans in appropriate system.
- Provides system support (i.e. GoBalto & eTMF).
- Supports RBM activities.
but not limited to:
timely processing of documents sent to Client (e)TMF as assigned, performing
(e)TMF reviews, performing mass mailings and communications as needed,
providing documents and reports to internal team members.
- Supports scheduling of client and/or internal meetings.
- Reviews and tracks local regulatory documents.
- Transmits documents to client and centralized IRB/IEC.
- Analyzes and reconciles study metrics and findings reports. Assists with
- Maintains vendor trackers.
- Assists with coordination, compilation and distribution of Investigator Site File
- Assists with study-specific translation materials and translation QC upon request.
little or no role in decision-making.
Job Knowledge Acquires job skills and learns company policies and procedures to complete routine
tasks.
Supervision
Received
Normally receives detailed instructions on all work. Works under close supervision.
Business
Relationships
Contacts are primarily within immediate work unit. Contacts involve obtaining or
providing information requiring little explanation or interpretation.
Qualifications:
Education and Experience:
High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification.
Bachelor's degree preferred.
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0
to 1 year).
In some cases an equivalency, consisting of a combination of appropriate education, training
and/or directly related experience, will be considered sufficient for an individual to meet the
requirements of the role.
Knowledge, Skills and Abilities:
- Ability to work in a team or independently as required
- Good organizational skills and strong attention to detail, with proven ability to handle multiple tasks
- Demonstrated ability to effectively analyze project-specific data/systems to ensure accuracy and
- Strong customer focus
- Flexibility to reprioritize workload to meet changing project timelines
- Demonstrated ability to attain and maintain a good working knowledge of applicable Country
- Good English language and grammar skills and proficient local language skills as needed
- Good computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain
- Ability to successfully complete PPD clinical training program
- Self-motivated, positive attitude and good interpersonal skills
Management Role:
No management responsibility
Working Conditions and Environment:
- Work is performed in an office/laboratory/clinical and/or home office environment with exposure to
- Occasional drives to site locations. Potential Occasional travel required.
Physical Requirements:
- Frequently stationary for 4-6 hours per day.
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements
- Occasional mobility required.
- Occasional crouching, stooping, bending and twisting of upper body and neck.
- Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop
- Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
- Ability to communicate information and ideas so others will understand; with the ability to listen to
- May interact with others, relating and gathering sensitive information. Interaction includes diverse
- Works with guidance or reliance on oral or written instructions from management. May require
- Performs a wide range of variable tasks as dictated by variable demands and changing conditions
- Regular and consistent attendance.
Percent Billable:
80% - 100%
Created by / last revised by
(Manager Name):
Naomi Wilson / Mary
Barnhill
Title:
ED Centers for Clinical Dev/ Dir
Clin Admin
Compensation Review By:
Sarah Hasch
Title:
Assoc Comp Analyst
Last Revision Date: 1/10/2020
This document is intended to describe the general nature and level of work being performed
by this job. This document is not intended to be construed as an exhaustive list of all
responsibilities, duties and skills required. Individual responsibilities will be defined by your
leadership team and will vary based on business needs.
-
ctc i
4 weeks ago
Shanghai, Shanghai, China ThermoFisher Scientific Full timeJob DescriptionClinical Trial CoordDivision / Dept.: Various Reports to Title: Supv or AboveJob Code: CD451 Job Family: Clin DevJob Level: A1 FLSA Status: NonexemptSummarized Purpose:Provides administrative and technical support to the Project Team. Supports audit readiness by ensuringfiles are reviewed on schedule detailed in the organization's WPD and...