[Remote] Assistant CRA FSP at Thermo Fisher Scientific

Argentina

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Clinical Trials, HealthcareIndustries

Requirements

Bachelor's degree in a life science or related field, or Registered Nursing certification, or equivalent relevant formal academic/vocational qualification
Previous experience providing knowledge, skills, and abilities to perform the job (comparable to 0-2 years); equivalency of appropriate education, training, and/or directly related experience may be considered
Basic medical/therapeutic area knowledge and understanding of medical terminology
Ability to attain and maintain a solid understanding of ICH GCP, applicable regulations, and company procedural documents
Effective oral and written communication skills
Excellent interpersonal and customer service skills
Good interpersonal and time management skills, strong attention to detail, with ability to balance multiple tasks efficiently
Shown flexibility and adaptability
Ability to work in a team or independently as needed
Well-developed critical thinking skills, including critical attitude, in-depth investigation for root cause analysis, and problem solving
Proficient digital literacy with good knowledge of MS Office, ability to learn and use appropriate software, and leverage modern technology

Responsibilities

Performs remote activities on assigned projects in liaison with the CRA and study Clinical Lead, providing support for site preparedness, logistical support to monitoring, and assigned tasks for site management and remote monitoring per SOPs and regulatory guidelines
May perform limited site contact activities during study start-up, site management, recruitment, and close-out phases
Completes study and site management activities as defined in task matrix
Completes and details study-specific training; orients and trains on study-specific systems
Provides in-house support during pre-study assessments and with pre-study assessment waivers
Supports customization of Site ICF with site contact details as needed
Performs remote review of EMR/EHR checklist and supports collection as applicable
Verifies document collection and RCR submission status; updates site EDL and verifies site information
Reviews patient-facing materials and translations as advised
Supports site staff with vendor-related qualification process where applicable
Ensures system access is requested/granted and revoked for relevant site staff during pre-activation and study course
Follows up on site staff training as applicable
Coordinates logistics for IM attendance as advised
Supports maintenance of vendor trackers as advised
Coordinates study/site supply management during pre-activation and study course
Supports crucial document collection, review, and updating in systems as applicable
Follows up on missing study vendor data (e.g., ECGs, lab samples, e-diaries) as advised
Supports ongoing remote review of centralized monitoring tools as advised
Supports site payments processes by coordinating with functional departments and sites, including system updates, reconciliations, and follow-up on invoices
Performs reconciliation tasks on assigned trials (e.g., CRF and query status, deviations, SAEs, safety reports) as applicable
Verifies document collection status in company systems and drives action for missing/incomplete/expired documents and open findings as directed

Skills

Clinical Research

Site Management

Remote Monitoring

SOP Compliance

Regulatory Guidelines

EMR/EHR

ICF Customization

Vendor Management

Study Supply Management

Document Collection

Patient Materials Review

Centralized Monitoring

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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