Clinical Project Coordinator/Clinical Trial Assistant

CTI Clinical Trial and Consulting Services; Sydney; Hybride; AUD 70 000 - 110 000; Plein temps

Avantages offerts par ce poste

Hybrid work from home schedule

Tuition assistance

Career progression opportunities

Résumé du poste

CTI Clinical Trial and Consulting Services seeks a capable professional to assist Clinical Project Managers/Directors across all project phases. You will provide back-up management, help prepare data reports for sites and CRA management, and support site operations in line with CTI SOPs.

You’ll contribute to start-up activities, enrollment tracking, and internal/external communications with sites, vendors, sponsors, and team members in a hybrid work environment.

Qualifications

• Bachelor's degree in allied health fields such as nursing, pharmacy, or health / natural science or an equivalent combination of education and relevant work experience
• Minimum of 1 to 3 years of experience in clinical research related field

Responsabilités

• Support Clinical Project Manager / Director in completing management activities; supports activities through all phases of a clinical project; provide back-up management as needed
• Update Clinical Project Manager / Director on progress, outstanding items, and issues as they arise; support Clinical Project Manager / Director with issue resolution
• Assist Clinical Project Manager / Director with preparing data reports for site and Clinical Research Associate (CRA) management; provide support for site management activities
• Develop initial drafts of clinical project plans, manuals, presentations, and other clinical project documents; assist in reviewing and maintaining these presentations and documents as required per CTI Standard Operating Procedures (SOPs)

Description du poste

• Support Clinical Project Manager / Director in completing management activities; supports activities through all phases of a clinical project; provide back-up management as needed
• Update Clinical Project Manager / Director on progress, outstanding items, and issues as they arise; support Clinical Project Manager / Director with issue resolution
• Assist Clinical Project Manager / Director with preparing data reports for site and Clinical Research Associate (CRA) management; provide support for site management activities
• Develop initial drafts of clinical project plans, manuals, presentations, and other clinical project documents; assist in reviewing and maintaining these presentations and documents as required per CTI Standard Operating Procedures (SOPs)
• Prepare initial drafts, including templates and content, of internal reports, external reports, newsletters, and other clinical project communications; distribute reports and communications to sites, vendors, Sponsors, and internal team members
• Assist with tracking project scope and internal financial reporting
• Prepare initial drafts of detailed meeting agendas and minutes; assist in initial review of meeting documents prepared by others; attend routine internal and external team meetings
• Monitor and maintain tracking tools, clinical systems and shared document repositories utilized for clinical project management
• Support the review and tracking of site pre-screening, screening, and enrollment activities as well as subject status information; follow up with internal clinical project team and/or sites as necessary regarding any identified issues
• Support tracking of action items and internal team follow-up
• Support and prepare / maintain tracking of clinical project start-up activities and milestones, including site selection and site start-up activities
• Assist the clinical project team with developing feasibility surveys and survey content; participate in feasibility calls; assist with any site follow-up needed throughout start-up
• Assist Clinical Project Manager / Director with documenting clinical project and Standard Operating Procedure (SOP)-related deviations
• Support and maintain clinical project documents in paper and/or electronic Trial Master Files and support Clinical Project Manager / Director with TMF reconciliation and period review follow-up
• Participate in preparing and following-up from internal and external audits; participate in audits as needed
• Assist with the management of all clinical project-related supplies and drug management
• Assist other departments as needed throughout all phases of clinical projects (e.g., Regulatory Affairs Study Start-up, Data Management, Safety, etc.)
• Provide support in developing new Clinical Project Coordinators, Clinical Project Assistants, and Research Associates (RAs) in clinical projects
• Assist with orientating new Clinical staff
• Provide third party vendor support
• Represent CTI in professional manner and foster collaboration with all clinical project teams / functional departments; assist in promoting interdepartmental cohesiveness

What You'll Do

• Support Clinical Project Manager / Director in completing management activities; supports activities through all phases of a clinical project; provide back-up management as needed
• Update Clinical Project Manager / Director on progress, outstanding items, and issues as they arise; support Clinical Project Manager / Director with issue resolution
• Assist Clinical Project Manager / Director with preparing data reports for site and Clinical Research Associate (CRA) management; provide support for site management activities
• Develop initial drafts of clinical project plans, manuals, presentations, and other clinical project documents; assist in reviewing and maintaining these presentations and documents as required per CTI Standard Operating Procedures (SOPs)
• Prepare initial drafts, including templates and content, of internal reports, external reports, newsletters, and other clinical project communications; distribute reports and communications to sites, vendors, Sponsors, and internal team members
• Assist with tracking project scope and internal financial reporting
• Prepare initial drafts of detailed meeting agendas and minutes; assist in initial review of meeting documents prepared by others; attend routine internal and external team meetings
• Monitor and maintain tracking tools, clinical systems and shared document repositories utilized for clinical project management
• Support the review and tracking of site pre-screening, screening, and enrollment activities as well as subject status information; follow up with internal clinical project team and/or sites as necessary regarding any identified issues
• Support tracking of action items and internal team follow-up
• Support and prepare / maintain tracking of clinical project start-up activities and milestones, including site selection and site start-up activities
• Assist the clinical project team with developing feasibility surveys and survey content; participate in feasibility calls; assist with any site follow-up needed throughout start-up
• Assist Clinical Project Manager / Director with documenting clinical project and Standard Operating Procedure (SOP)-related deviations
• Support and maintain clinical project documents in paper and/or electronic Trial Master Files and support Clinical Project Manager / Director with TMF reconciliation and period review follow-up
• Participate in preparing and following-up from internal and external audits; participate in audits as needed
• Assist with the management of all clinical project-related supplies and drug management
• Assist other departments as needed throughout all phases of clinical projects (e.g., Regulatory Affairs Study Start-up, Data Management, Safety, etc.)
• Provide support in developing new Clinical Project Coordinators, Clinical Project Assistants, and Research Associates (RAs) in clinical projects
• Assist with orientating new Clinical staff
• Provide third party vendor support
• Represent CTI in professional manner and foster collaboration with all clinical project teams / functional departments; assist in promoting interdepartmental cohesiveness

What You'll Bring

• Bachelor's degree in allied health fields such as nursing, pharmacy, or health / natural science or an equivalent combination of education and relevant work experience
• Minimum of 1 to 3 years of experience in clinical research related field

Why CTI?

• We support career progression - We believe in promoting from within and we have a structured mentoring program and program for recent graduates to provide the support employees need to move forward
• We value education and training - We provide tuition assistance, partner with universities and colleges to create programs in our field, and have a dedicated training department
• We value our people - We guaranteed full pay for our employees during the COVID-19 shut-down regardless of the number of hours worked. We support a work-life balance and the importance of time with family by offering generous vacation time and a hybrid work from home schedule
• Our culture is unparalleled - We've received multiple awards recognizing CTI as one of the best places to work in the greater Cincinnati area, as well as one of the top CROs in the industry
• We think globally and act locally - With employees across 60 countries, we have global reach but maintain culture and connections to the local communities in which we work. Our CTI Cares Committees are dedicated to ensuring the CTI culture and values translate around the world.
• We are looking toward the future - We have had a consistent double-digit growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average annual retention rate of 95%, which is much higher than many other CROs
• Our work makes a difference - We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-changing therapies to market