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CTC

79% Flex

EXTRA HOLIDAYS - EXTRA PARENTAL LEAVE

Remote:

Full Remote

Contract:

Full time

Work from:

Argentina

Offer summary

Qualifications:

High/Secondary diploma or higher, Bachelor's degree preferred.

Key responsabilities:

Coordinate trial functions
Review regulatory compliance

Thermo Fisher Scientific Biotech: Biology + Technology Large https://www.thermofisher.com/

10001 Employees

HQ: Waltham

See more Thermo Fisher Scientific offers

Job description

Your missions

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Purpose:

Thermo Fisher Scientific Inc. is seeking a Clinical Trial Coordinator (CTC) to join our team. You will have the opportunity to work on world-class research projects and collaborate with experts in a fast-paced environment to ensure flawless execution and efficient site activations.

Essential Functions:

Coordinate, oversee, and successfully implement functions on assigned trials.
Perform meticulous department, internal, country, and investigator file reviews, documenting findings.
Ensure tasks are completed on time, within budget, and to a high-quality standard; proactively communicate risks.
Provide system support and maintain current, accurate databases.
Complete various administrative tasks, such as processing documents in a timely manner, conducting eTMF reviews, and distributing communications.
Analyze and reconcile study metrics, aiding in resolution of site documentation findings.
Coordinate and distribute Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies.
Assist in study-specific translation materials and quality control.
Maintain knowledge of SOPs, client directives, and regulatory guidelines.
Conduct on-site feasibility visits as required.
Support scheduling of client/internal meetings and track regulatory documents.
Provide system support, including Activate & eTMF, and support RBM activities.
Maintain study-specific documentation and systems.
Transmit documents to clients and centralized IRB/IEC.
Maintain vendor trackers and support start-up team in regulatory submissions.
Work with sites to obtain documents related to site selection.
Assist in preparation of regulatory compliance review packages.
Coordinate with internal departments to align site start-up activities.
Document real-time communication and follow-up with site contacts.
Review survey data for logical, complete responses.
Collaborate with teammates to meet project deadlines and communicate site issues.
Implement and ensure compliance with site contact plans, advancing concerns as needed.
Serve as local expert on site capacity and experience, recommending additional sites.
Liaise with Global Investigator Services to resolve queries and maintain contact information.
Contribute to global strategic feasibility processes and development of standard methodologies.
Train new personnel in processes and systems.
Apply local knowledge to identify and develop new sites.

Education and Experience:

High/Secondary school diploma or equivalent. Bachelor’s degree or equivalent experience preferred.

Knowledge, Skills, and Abilities:

Team-oriented with the ability to work independently.
Exceptional organizational skills and attention to detail.
Proven ability to manage multiple tasks efficiently.
Strong customer focus and flexibility to adapt to changing project timelines.
Proficient in MS Office and clinical trial database systems.
Positive attitude, self-motivated, and strong interpersonal skills.
Effective communication and negotiation skills.
Skilled problem solver with excellent judgment and decision-making abilities.
Skill in effectively managing risks and advancing them as needed.

Working Conditions and Environment:

Work is performed in various environments, including office, laboratory, clinical, and home office settings.
Occasional travel required.
This position is remote.