FSP Clinical Trial Coordinator II

🔥 15 minutes ago

🇦🇷 Argentina – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

✨ Clinical Trial Coordinator

🚫👨‍🎓 No degree required

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Coordinate, oversee, and complete assigned trial activities according to the task matrix • Perform department, internal, country, and investigator file reviews and document findings • Complete allocated tasks on time, within budget, and to a high-quality standard; communicate risks to project leads and line manager • Process client (e)TMF documents, perform (e)TMF reviews, distribute mailings and communications, and provide documents and reports • Review and track local regulatory documents • Analyze and reconcile study metrics and findings reports; assist with resolving site-documentation findings • Maintain vendor trackers and study status information in databases • Coordinate, compile, and distribute Investigator Site File and Pharmacy binder materials and non-clinical study supplies • Support study-specific translation materials and translation quality control • Provide technical and administrative project support in collaboration with internal departments and team members • Maintain knowledge of SOPs, client directives, and current regulatory guidelines • Maintain client local-affiliate relationships where applicable • Train new personnel and support departmental process improvements • Maintain study documentation, team lists, training requirements, system access, activity plans, and (e)TMF records • Provide system support for Activate and eTMF and may support RBM activities • Transmit documents to clients and centralized IRB/IEC • Attend kick-off meetings, take notes, and support meeting scheduling and minutes • Coordinate with internal departments to align site start-up activities with the site activation critical path • Prepare regulatory compliance review packages and support regulatory submissions • Obtain site-selection documents and develop site lists from internal and external sources • Maintain investigator/site staff contact details and complete Site Interest Plans in CTMS • Review survey data and ensure effective site contact and follow-up plans • Collaborate with teammates and clinical personnel on site issues, risks, deadlines, and escalations • Act as a local expert on site capacity and experience; support site tiering and recommend additional sites • Conduct phone interviews with physicians and site personnel regarding standard of care and protocol input • Liaise with Global Investigator Services and contribute to global feasibility processes and best practices

🎯 Requirements

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification • Bachelor's degree preferred • At least 2 years of previous experience providing relevant knowledge, skills, and abilities • Equivalency may be considered through a combination of appropriate education, training and/or directly related experience • Ability to work independently or in a team environment • Strong organizational skills and attention to detail; ability to manage multiple tasks efficiently • Ability to analyze project-specific data/systems for accuracy and efficiency • Strong customer focus, flexibility, adaptability, and reprioritization skills • Working knowledge of applicable country regulations, ICH Good Clinical Practices, organization/client SOPs and WPDs • Excellent English language and grammar skills and proficient local language skills as needed • Good presentation, negotiation, interpersonal, oral and written communication skills • Proficiency in MS Office (Word, Excel, and PowerPoint) and ability to learn clinical trial database systems and appropriate software • Ability to complete the organization's clinical training program • Basic medical/therapeutic area and medical terminology knowledge • Basic organizational, planning, and local health systems knowledge • Ability to attain and maintain knowledge of GCP and applicable SOPs • Ability to work in a matrix environment, manage risk, and perform risk escalation appropriately • Fluency in the local language and good command of English • Potential occasional travel and occasional drives to site locations

🏖️ Benefits

• Fully Remote work arrangement • Full-time employment • Standard Monday–Friday work schedule