[Remote] Clinical Trial Coordinator II at Thermo Fisher Scientific

Argentina

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Not SpecifiedCompensation

Junior (1 to 2 years), Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Clinical ResearchIndustries

Requirements

Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided
Trains new personnel in processes and systems
Where applicable, develops and maintains relationship with client local affiliates
Where applicable, conducts on-site feasibility visits (Asia Pac only)

Responsibilities

Coordinates, oversees and completes functions on assigned trial(s) activities as detailed on the task matrix (Central or Local role)
Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system(s)
Ensures allocated tasks are performed on time, within budget and to a high quality standard; proactively communicates risks to project leads and line manager
Performs administrative tasks on assigned trials including timely processing of documents to Client (e)TMF, (e)TMF reviews, distributing mass mailings and communications, providing documents and reports to internal team members
Reviews and tracks local regulatory documents
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
Assists with technical and administrative support for projects in collaboration with internal departments and team members
Ensures trial status information relating to activities is accurately maintained in the database and current at all times
Champions the inclusion of Strategic Collaboration sites into the process
May support the maintenance of study specific documentation and global support with specific systems, tools and trackers (e.g., study team lists, tracking of project specific training requirements, system access management, tracking of project level activity plans)
Ensures (e)TMF is up to date by following file review schedules and documenting findings in appropriate system(s)
May provide system support (i.e., Activate & eTMF)
May support RBM activities
May transmit documents to client and centralized IRB/IEC
May attend Kick off Meeting and take notes when required
May support scheduling of client and/or internal meetings
May support scheduling and organization of client and/or internal meetings with completion of related meeting minutes
Provides support as needed to coordinate with internal departments and ensure site start-up activities within the site activation critical path are aligned
Assists the project team with the preparation of regulatory compliance review packages
May support start-up team in Regulatory submissions
Occasionally works directly with site(s) to obtain documents related to site selection
May develop site list, including research from internal and external sources to ensure the site list is reflective of the defined site profile; ensures current investigator and site staff contact details are maintained in company systems
May complete the ‘Site Interest Plan’ in CTMS and collection and delivery of associated documents from investigators and site personnel; documents in real time all communication, attempts and follow up associated with site contact and survey responses
Supports the review of survey data to ensure responses are logical, complete and reflective of the question asked
Works in collaboration with teammates to achieve targeted deadlines for assigned projects; communicates with the team and appropriate clinical personnel

Skills

Key technologies and capabilities for this role

Clinical TrialsTMFeTMFRegulatory DocumentsSOPsStudy MetricsISFVendor TrackingFeasibility VisitsProject CoordinationDocument ProcessingQuality ControlAdministrative Support

Questions & Answers

Common questions about this position

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

This is an office-based role with standard Monday-Friday hours.

What are the key responsibilities of the Clinical Trial Coordinator II?

The role involves coordinating trial activities per the task matrix, performing file reviews, ensuring tasks are on time and within budget, handling administrative tasks like document processing and TMF reviews, and tracking regulatory documents and metrics.

What salary or compensation is offered for this position?

This information is not specified in the job description.

What skills or experience make a strong candidate for this role?

Strong candidates will have experience with clinical trial coordination, regulatory document management, TMF systems, SOPs, and regulatory guidelines, along with organizational skills for administrative tasks and proactive risk communication.

Does the role involve training or supporting team members?

Yes, the position includes training new personnel in processes and systems and providing support to internal teams.

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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