Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
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.
Want more jobs like this?
Get jobs that are Remote delivered to your inbox every week.
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.