[Remote] FSP Assistant CRA (Inhouse CRA) (Sponsor: Roche) at Thermo Fisher Scientific

Igołomia-Wawrzeńczyce, Lesser Poland Voivodeship, Poland

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Not SpecifiedCompensation

Entry Level & New Grad, Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, Clinical ResearchIndustries

Requirements

Basic medical/therapeutic area knowledge and understanding of medical terminology
Ability to attain and maintain a working knowledge of ICH GCP, applicable regulations and CRG procedural documents
Effective oral and written communication skills
Excellent interpersonal and customer service skills
Good organizational and time management skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively
Proven flexibility and adaptability
Ability to work in a team or independently, as required
Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
Proficient computer skills with good knowledge of MS Office; ability to learn and use appropriate software; leverage modern technology when applicable
Ability to extract pertinent information from all study documents, electronic study data systems, CTMS and dashboards
Excellent English language and grammar skills

Responsibilities

Completes study and site management activities as defined in task matrix, and as applicable and directed for study assigned
Completes and documents study-specific training
Orients and trains on any CRG/study-specific systems
Provides in-house support during pre-study assessments and with pre-study assessment waivers, as agreed for project
Supports to customize Site ICF with site contact details, as needed
Reviews patient facing materials and review translations, as directed
Supports site staff with the vendor related qualification process, where applicable
Provides support by ensuring system access is requested/granted and revoked for relevant site staff during pre-activation and subsequent course of the study
Provides support to follow-up on site staff training, as applicable
Coordinates and supports logistics for IM attendance, as directed
Supports maintenance of vendor trackers, as directed
Coordinates study/site supply management during pre-activation and subsequent course of the study
Supports Essential Document collection, review and updating in systems, as applicable
Follows up and supports on missing study vendor data like ECGs, lab samples, and e-diaries, as directed
Supports ongoing remote review of centralized monitoring tools, as directed
Supports Site payments processes by coordinating with various functional departments within organization and site; supports system updates and reconciliations, as directed; follows-up on site invoices throughout the study period
Performs reconciliation tasks on assigned trials including but not limited to CRF and query status, deviations, SAEs and safety reports, as applicable
Verifies document collection status in CRG systems and drives action for missing/incomplete/expired documents and open document findings, as directed

Skills

Key technologies and capabilities for this role

study managementsite managementCRG systemsICF customizationpatient facing materialsvendor qualificationsystem access managementsite staff traininglogistics coordinationsupply managementessential documentscentralized monitoringsite paymentsreconciliationCRFquery managementdeviationsSAEssafety reports

Questions & Answers

Common questions about this position

What skills are required for the FSP Assistant CRA role?

Required skills include basic medical/therapeutic area knowledge, understanding of medical terminology, effective communication, interpersonal and customer service skills, organizational and time management skills, flexibility, critical thinking, proficient computer skills with MS Office, and excellent English language skills.

Is this a remote position or does it require office work?

The role is based in an office environment with a standard Monday-Friday work schedule.

What is the salary or compensation for this position?

This information is not specified in the job description.

What kind of work environment or team setup is there?

The role involves working in a team or independently as required, in an office setting focused on clinical research support for Roche studies.

What makes a strong candidate for this Assistant CRA position?

Strong candidates demonstrate proven flexibility, adaptability, critical thinking for root cause analysis, ability to handle multiple tasks efficiently, and proficiency in extracting information from study documents and systems.

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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