Clinical Trial Coordinator I

🔥 14 hours ago

🇲🇽 Mexico – 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 by ensuring files are reviewed according to the organization's SOP and department guidance. • Provide administrative support for site activation activities and aid in developing the site activation critical path. • Develop and review site lists for feasibility activities and provide local input into site tiering. • Coordinate, oversee, and complete assigned trial activities according to the task matrix. • Perform department, internal, country, investigator, and eTMF file reviews and document findings. • 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 databases current. • Process documents to the Client eTMF, perform eTMF reviews, distribute communications, and provide documents and reports. • Analyze and reconcile study metrics and findings reports; assist with resolution of site documentation findings. • Coordinate and distribute Investigator Site File and Pharmacy binder materials and non-clinical study supplies. • Support study-specific translation materials and translation quality control. • Conduct on-site feasibility visits where applicable in Asia Pacific. • Support client/internal meeting scheduling and local regulatory document tracking. • Support RBM activities and study documentation/system maintenance. • Transmit documents to clients and centralized IRB/IEC. • Maintain vendor trackers. • Support regulatory submissions and site start-up activities. • Work with sites to obtain site-selection documents and complete regulatory compliance review packages. • Document site contacts, 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 site contact and follow-up plans are implemented and escalate concerns or non-compliance. • Provide local expertise 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 feasibility processes and best practices. • Train new personnel in processes and systems. • Utilize local knowledge to identify and develop new sites. • May act as a buddy during onboarding.

🎯 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. • Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout. • 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 ability to obtain knowledge and master all clinical trial database systems. • Ability to successfully complete the organizations 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. • Occasional drives to site locations and potential occasional travel required.