Clinical Trial Coordinator

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Job description:

Provides administrative and technical support to the Project Team. Supports audit readiness by ensuring files are reviewed according to the schedule detailed in the organization's SOP and department guidance document. Provides administrative support for site activation activities. Aids the development of the critical path for site activation within assigned projects in support of rapid site activations. Represents CRG personnel. May act as a buddy during onboarding phase and provide training to new staff as needed.

· Mainly responsible for IRB submission including but not limited initial, amendment and safety submission.

· According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trial(s) activities as detailed on the task matrix.

· Ensures allocated tasks are performed on time, within budget and to a high quality standard. Proactively communicates any risks to project leads.

· Provides system support (i.e., CTMS & eTMF) and ensures system databases are always current.

· Performs administrative tasks on assigned trials, including, but not limited to, timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, distributing mass mailings and communications as needed, providing documents and reports to internal team members.

· Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.

· Assists with study-specific translation materials and translation QC upon request.

· Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided.

· Where applicable, conducts on-site feasibility visits (Asia Pac only).

· May support scheduling of client and/or internal meetings.

· May provide system support (i.e. eTMF).

· Transmits documents to client and centralized IRB/IEC.

· Maintains vendor trackers.

· Supports start-up team in IRB submissions.

· Works directly with sites to obtain documents related to site activation. Assists the project team with the preparation of regulatory compliance review packages.

· Provides support as needed to coordinate with internal departments, ensuring site start-tup activities within the site activation critical path are aligned..

· Works in collaboration with teammates to achieve targeted deadlines for assigned projects. Communicate with the team and appropriate clinical personnel

regarding site issues and risks.

· Ensures an efficient, effective plan is in place for site contact and follow up.

· Ensure compliance with the plan and escalate concerns/non-compliance to management.

· May act as the local expert regarding site capacity and experience. Work with key local personnel to gather knowledge base and recommend additional sites.

· Trains new personnel in processes and systems.

Requirements:

• Minimum bachelor degree (major in nursing, pharmacy or other science-related background) 
• At least 1 year working experience in the clinical research industry as a CTC or submission specialist in global pharma or CRO.