Corporate Compliance Associate II at Thermo Fisher Scientific

Wrocław, Lower Silesian Voivodeship, Poland

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Not SpecifiedCompensation

Entry Level & New GradExperience Level

Full TimeJob Type

UnknownVisa

Healthcare, Biotechnology, Clinical ResearchIndustries

Requirements

High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification (technical positions may require a certificate)
Ability to multi-task and support multiple studies with a number of participants simultaneously
Good interpersonal skills
Excellent communication skills with Polish and English
Basic MS Office and computer skills
Ability to learn basic medical terminology
Good attention to detail

Responsibilities

Perform data collection and data entry to CRF
Track the flow of CRFs, queries, and patient recruitment status and report out the flow of data
Set up project files, ensuring sufficiency and accuracy of versions of appropriate documentation
Assist with producing guidelines for the data entry process for studies
Ensure individual development and continual service improvement
Act as a Data Coordinator on ongoing projects to assist with delivery within timelines
Deliver good quality data by ensuring understanding of source documentation and transcription into CRF
Create good relationships with customers and ensure high level of customer service
Work according to SOP/COPs and GCP guidelines
Perform quality control as described in relevant procedures and applicable to the role
Maintain ISF and study trackers as delegated and support verification that ICFs are correctly completed
Assist with data capturing activities on one or more studies, potentially supporting multiple sites and/or regions
Ensure accurate and timely entry of all data in the eCRF from source notes and help track the flow of eCRFs and queries
Assist with verification that protocol visit windows are correct according to protocol requirements and report deviations
Assist monitors and sponsor representatives with query resolutions after monitoring visits and escalate to management as needed
Learn and adhere to company SOP and COP and assist with input during the review process
Adhere to ICH, GCP, other regulatory and ethical guidelines, and data protection regulations
Assist with drafting compliance reports
Other duties as assigned (e.g., named archives)

Skills

Key technologies and capabilities for this role

data entrydata validationdiscrepancy managementCRFGCPSOPquality controlclinical datapatient recruitment trackingproject coordination

Questions & Answers

Common questions about this position

What is the work arrangement or location for this role?

This is a full-time position with a standard Monday-Friday schedule in an office environment.

What are the main responsibilities of the Corporate Compliance Associate II?

Responsibilities include data collection and entry into CRFs, tracking CRFs, queries, and patient recruitment status, setting up project files, assisting with data entry guidelines, quality control, maintaining ISF and study trackers, and adhering to SOPs, GCP, and regulations.

What qualifications are required for this position?

The role requires High / Secondary school qualifications.

What is the company mission at Thermo Fisher Scientific?

The mission is to enable customers to make the world healthier, cleaner, and safer through research, development, and delivery of life-changing therapies.

What salary or compensation is offered for this role?

This information is not specified in the job description.

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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