Corporate Compliance Associate II

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Supports compliance to the clinical trial process. Helps ensure all study documentation and source data is captured accurately in eCRF, up to date and first time right. Assists with quality reviews and answers any eCRF queries for studies with low complexity in a timely manner. 

Day to Day

Maintains ISF and study trackers as delegated and supports the verification that ICFs are correctly completed. 

• Assists with data capturing activities on one or more studies.  

• Ensures accurate and timely entry of all data in the eCRF from the source notes and helps track the flow of the eCRFs and queries.    

• Assists with the verification that protocol visit windows are correct according to the protocol requirements and reports deviations/ Quality Incidents and participates in the investigation and resolution. 

• May assist monitors and sponsor representatives with query resolutions after monitoring visits. Escalates to management as needed. 

Qualifications:   

 
Education and Experience:   

 

High  /  Secondary school diploma or equivalent and relevant formal academic / vocational qualification 

Technical positions may require a certificate 

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years).

• Learns and adheres to company SOP and COP and assists with input during the review process. 

• Adheres to the rules and regulations of ICH, GCP and other regulatory and ethical guidelines and data protection regulations. 

• Assists with drafting compliance reports

Knowledge, Skills and Abilities:  

 

• Ability to multi-task and support multiples studies with a number of participants simultaneously 

• Good interpersonal skills 

• Good working knowledge of Business English 

• Basic MS Office and computer skills 

• Ability to learn basic medical terminology 

• Good attention to detail 

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 as per EHS regulations.  

• 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.