Job Description

Clinical 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

completes functions on assigned trials activities detailed on the task matrix.

• Performs department, Internal, Country and Investigator file reviews as assigned

and documents findings in appropriate system.

• Ensures allocated tasks are performed on time, within budget and to a high

quality standard. Proactively communicates any risks to project leads.

• 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.

• Performs administrative tasks on assigned trials including 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

clarification and resolution of findings related to site documentation.

• Maintains vendor trackers.

• Assists with coordination, compilation and distribution of Investigator Site File

(ISF) and Pharmacy binder materials and non-clinical study supplies to sites.

• Assists with study-specific translation materials and translation QC upon request.

Job Complexity Works on assignments that are routine in nature, requiring limited judgment. Has

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

efficiently and effectively

• Demonstrated ability to effectively analyze project-specific data/systems to ensure accuracy and

efficiency

• 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

Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all nonclinical/clinical aspects of project implementation, execution and closeout

• 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

knowledge and master all clinical trial database systems

• 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

electrical office equipment.

• 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

of the fingers, hands, and wrists.

• 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

computer with a maximum lift of 15-20 lbs.

• 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

and understand information and ideas presented through spoken words and sentences.

• May interact with others, relating and gathering sensitive information. Interaction includes diverse

groups.

• Works with guidance or reliance on oral or written instructions from management. May require

periods of intense concentration.

• Performs a wide range of variable tasks as dictated by variable demands and changing conditions

with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.

• 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.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.