FSP Clinical Trial Coordinator II

at  Thermo Fisher Scientific

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.
Our global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.

QUALIFICATIONS: EDUCATION AND EXPERIENCE:

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 at least 2 years).

• Requirement: SSU/Regulatory Process.

May support the maintenance of study specific documentation and global support with specific systems, tools and trackers, including, but not limited to, study team lists, tracking of project specific training requirements, system access management for organization/vendor/clients and tracking of project level activity plans in appropriate system. Ensures (e)TMF is up to date by following file review schedules and documenting findings in appropriate system(s).

• May provide system support (i.e., Activate & eTMF).
• May support RBM activities.
• May transmit documents to client and centralized IRB/IEC.
• May attend Kick off Meeting and take notes when required.
• May support scheduling of client and/or internal meetings
• May support scheduling and organization of client and/or internal meetings with completion of related meeting minutes.
• Provides support as needed to coordinate with internal departments and ensure site start-up activities within the site activation critical path are aligned.
• Assists the project team with the preparation of regulatory compliance review packages.
• May support start-up team in Regulatory submissions.
• Occasionally works directly with site(s) to obtain documents related to site selection.
• May develop site list, including research from internal and external sources to ensure the site list is reflective of the defined site profile. Ensure current investigator and site staff contact details are appropriately maintained in company systems.
• May complete the ‘Site Interest Plan’ in CTMS and collection and delivery of associated documents from investigators and site personnel. Document in real time all communication, attempts and follow up associated with site contact and survey responses.
• Supports the review of survey data to ensure responses are logical, complete and reflective of the question asked.
• 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 escalates 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. Harnesses this knowledge base when performing local tiering of sites.
• May conduct phone interviews, scripted or non-scripted, with physicians and other site personnel to discuss standard of care and obtain protocol-level input to support trial optimization projects.
• Liaises with Global Investigator Services to resolve investigator queries in real time and maintain ‘accounts and contact’ information.
• Contributes to the development and roll-out of global strategic feasibility processes and best practices

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

• Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system(s).
• Ensures allocated tasks are performed on time, within budget and to a highquality standard. Proactively communicates any risks to project leads and line manager as appropriate.
• 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.
• Reviews and tracks local regulatory documents.
• Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.
• Maintains vendor trackers.
• 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.
• Assists with technical and administrative support for projects in collaboration with internal departments and team members.
• Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided.
• Ensures that trial status information relating to activities is accurately maintained in the database and current at all times.
• Where applicable, develops and maintains relationship with client local affiliates.
• Champions the inclusion of Strategic Collaboration sites into the process.
• Where applicable, conducts on-site feasibility visits (Asia Pac only).
• Trains new personnel in processes and systems.

May support the maintenance of study specific documentation and global support with specific systems, tools and trackers, including, but not limited to, study team lists, tracking of project specific training requirements, system access management for organization/vendor/clients and tracking of project level activity plans in appropriate system. Ensures (e)TMF is up to date by following file review schedules and documenting findings in appropriate system(s).

• May provide system support (i.e., Activate & eTMF).
• May support RBM activities.
• May transmit documents to client and centralized IRB/IEC.
• May attend Kick off Meeting and take notes when required.
• May support scheduling of client and/or internal meetings
• May support scheduling and organization of client and/or internal meetings with completion of related meeting minutes.
• Provides support as needed to coordinate with internal departments and ensure site start-up activities within the site activation critical path are aligned.
• Assists the project team with the preparation of regulatory compliance review packages.
• May support start-up team in Regulatory submissions.
• Occasionally works directly with site(s) to obtain documents related to site selection.
• May develop site list, including research from internal and external sources to ensure the site list is reflective of the defined site profile. Ensure current investigator and site staff contact details are appropriately maintained in company systems.
• May complete the ‘Site Interest Plan’ in CTMS and collection and delivery of associated documents from investigators and site personnel. Document in real time all communication, attempts and follow up associated with site contact and survey responses.
• Supports the review of survey data to ensure responses are logical, complete and reflective of the question asked.
• 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 escalates 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. Harnesses this knowledge base when performing local tiering of sites.
• May conduct phone interviews, scripted or non-scripted, with physicians and other site personnel to discuss standard of care and obtain protocol-level input to support trial optimization projects.
• Liaises with Global Investigator Services to resolve investigator queries in real time and maintain ‘accounts and contact’ information.
• Contributes to the development and roll-out of global strategic feasibility processes and best practices.