Clinical Trial Coordinator II

🔥 0 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🚫👨‍🎓 No degree required

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 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 project risks to project leads and line manager • Process documents sent to the client eTMF, perform eTMF reviews, distribute mass mailings, and provide documents and reports to internal team members • Review and track local regulatory documents • Analyze and reconcile study metrics and findings reports • Assist with clarification and resolution of site documentation findings • Maintain vendor trackers • 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 applicable regulatory guidelines • Maintain accurate and current trial status information in databases • Develop and maintain relationships with client local affiliates where applicable • Champion inclusion of Strategic Collaboration sites • Conduct on-site feasibility visits where applicable for Asia Pacific roles • Train new personnel in processes and systems • Maintain study documentation, team lists, training requirements, system access, and project activity plans • Provide support for Activate, eTMF, and risk-based monitoring activities • Transmit documents to clients and centralized IRB/IEC • Attend kick-off meetings and take notes when required • Schedule and organize client/internal meetings and prepare meeting minutes • Coordinate with internal departments to align site start-up activities with the site activation critical path • Assist with regulatory compliance review packages and regulatory submissions • Obtain site-selection documents directly from sites when needed • Develop site lists and maintain investigator/site staff contact details • Complete Site Interest Plans in CTMS and document site communications and survey responses • Review survey data for logical, complete, and relevant responses • Collaborate with teammates to meet project deadlines and address site issues and risks • Ensure effective site contact and follow-up plans and escalate non-compliance • Serve as a local expert on site capacity and experience and support local site tiering • Conduct phone interviews with physicians and site personnel to obtain protocol-level input • Liaise with Global Investigator Services to resolve investigator queries and maintain account/contact information • Contribute to global strategic feasibility processes and best practices

🎯 Requirements

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification • Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to at least 2 years • Equivalency through a combination of appropriate education, training and/or directly related experience may be considered • Ability to work independently or in a team environment • Strong organizational skills and attention to detail • Ability to manage multiple tasks efficiently and effectively • Ability to analyze project-specific data/systems for accuracy and efficiency • Strong customer focus • Flexibility and adaptability to changing project timelines • 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 skills • Proficiency in MS Office (Word, Excel, PowerPoint) • Ability to learn and master clinical trial database systems and appropriate software • Ability to successfully complete the organization's clinical training program • Effective oral and written communication skills, including communication with medical personnel • Good negotiation skills • Basic medical/therapeutic area and medical terminology knowledge • Basic organizational and planning skills • Basic knowledge of local health systems • Working knowledge of GCP and applicable SOPs • Ability to work in a matrix environment • Relationship-building ability • Independent thinking • Ability to manage risk and perform appropriate risk escalation • Occasional drives to site locations; potential occasional travel

🏖️ Benefits

• Fully remote work arrangement • Standard Monday–Friday work schedule