Clinical Trial Coordinator I

🔥 12 hours ago

🇵🇱 Poland – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

✨ Clinical Trial Coordinator

👻 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

• Provide administrative and technical support to the Project Team. • Support audit readiness through scheduled department, internal, country, and investigator file reviews, documenting findings in appropriate systems. • Coordinate, oversee, and complete assigned trial activities according to the task matrix. • Ensure allocated tasks are completed on time, within budget, and to a high-quality standard; communicate risks to project leads. • Provide system support for Activate and eTMF and keep system databases current. • Process documents for the Client eTMF, perform eTMF reviews, distribute mass mailings and communications, and provide documents and reports to internal team members. • Analyze and reconcile study metrics and findings reports; assist with resolving site-documentation findings. • Coordinate, compile, and distribute Investigator Site File and Pharmacy binder materials and non-clinical study supplies to sites. • Support study-specific translation materials and translation quality control. • Maintain knowledge of SOPs, client directives, and regulatory guidelines. • Conduct on-site feasibility visits where applicable (Asia Pac only); occasional travel may be required. • Support client/internal meeting scheduling and tracking of local regulatory documents. • Support RBM activities and study documentation, training requirements, system access, and project activity plans. • Transmit documents to the client and centralized IRB/IEC. • Maintain vendor trackers. • Support the start-up team with regulatory submissions. • Work directly with sites to obtain site-selection documents. • Assist with regulatory compliance review packages and coordinate internal departments to align site start-up activities with the site-activation critical path. • Complete Site Interest Plans in CTMS where applicable and collect associated investigator/site documents. • Document site communications, follow-ups, and survey responses in real time; review survey data for completeness and logic. • Collaborate with teammates and clinical personnel to meet deadlines and address site issues and risks. • Ensure effective site-contact and follow-up plans, escalating concerns or non-compliance to management. • Act as a local expert on site capacity and experience, recommend additional sites, and support local site tiering. • Liaise with Global Investigator Services to resolve investigator queries and maintain account/contact information. • Contribute to global strategic feasibility processes and best practices. • Train new personnel in processes and systems. • Use local knowledge to identify and develop new sites.

🎯 Requirements

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification. • Bachelor's degree preferred. • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year). • In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. • Ability to work in a team or independently as required. • Good organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively. • Demonstrated ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency. • Strong customer focus. • Flexibility to reprioritize workload to meet changing project timelines. • Working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs. • Good English language and grammar skills and proficient local language skills as needed. • Good computer skills; proficient in MS Office (Word, Excel, and PowerPoint) and able to learn clinical trial database systems. • Ability to successfully complete the organization's clinical training program. • Self-motivated, positive attitude and good interpersonal skills. • Effective oral and written communication skills. • Essential judgment and decision-making skills. • Capable of accurately following project work instructions. • Good negotiation skills. • Independent thinker. • Ability to manage risk and perform risk escalation appropriately.