Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Join Us as a Principal Clinical Trial Coordinator – Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
As part of our global team, you’ll have the opportunity to provide administrative and technical support to the Project Team as a study lead, acting as a cross-functional liaison. As a Principal Clinical Trial Coordinator, you'll coordinate and facilitate project activities and oversee administration on assigned projects. You will act as a buddy during the onboarding phase, provide training to new staff, and identify new training requirements. You will support the creation, implementation, and change management for departmental and cross-functional process improvement/enhancement initiatives. Additionally, you will aid in the development of the critical path for site activation within assigned projects to support rapid site activations and serve as a point of escalation for project teams.
What You’ll Do:
• According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trial activities as detailed on the task matrix. Uses critical thinking to ensure tasks are proactively scheduled and fulfilled in line with project team needs.
• 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 high quality standard. Proactively communicates any risks to project leads and line manager as appropriate.
• Supports 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(s). Ensures (e)TMF is up to date by following file review schedules and documents findings in appropriate system(s).
• Supports RBM activities.
• 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.
• Supports scheduling and organization of client and/or internal meetings with completion of related meeting minutes.
• Reviews and tracks local regulatory documents. Supports project team to ensure audit readiness, (i.e. (e)TMF) and contributes to internal, regulatory and client audit responses as needed.
• Transmits documents to client and centralized IRB/IEC.
• 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.
• Provides system support (i.e., Activate & eTMF) and ensures systems databases are always current.
• Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided.
• Liaises locally to ensure local submission activity is planned and delivered in accordance with global project submission strategy.
• Ensures that trial status information relating to activities are accurately maintained in the database and is always current.
• 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 on processes and systems.
• Contributes to discussions with teammates in other regions to support a collaborative network with consistent processes and sharing of best practices.
• Expands therapeutic knowledge and expertise.
• Attends Kick off Meeting and take notes, when required.
• Provides training to other functional team members, Investigators and/or clients as requested.
• Serves as an alliance-level lead, handling client integration and (e)TMF activities.
• Provides technical and administrative support and coordination for projects in collaboration with relevant internal departments and team members to support the achievement of project target cycle times for site activations.
• Assists with the negotiation and finalization of site agreements, budgets, and essential documents with study sites in accordance with local/accepted process.
• Complies with established negotiation parameters, authority approval, contractual process and client expectations as developed and approved.
• Works directly with site(s) to obtain documents related to site selection.
• Assists with the preparation of regulatory compliance review packages, as applicable, which may include working directly with sites.
• Assists in developing country or site-specific documents.
• Provides support as needed to help with the coordination with internal functional departments to ensure site start-up activities within the site activation critical path are aligned.
• Develops 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 PPD systems.
• Completes 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 response goals 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.
• Acts 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.
• Conducts 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.
• Utilizes local knowledge to input into the identification and development of new sites within local market.
• Serves as a subject matter expert on feasibility survey tools and provides input on the development of future systems/releases.
Education and Experience Requirements:
• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification.
o Bachelor's degree preferred.
o Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 6 years).
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
• Ability to work in a team or independently as required
• Excellent organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively
• Excellent ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
• Demonstrated flexibility and adaptability to reprioritize workload and provide efficient support to meet changing project timelines
• Demonstrated ability to attain and maintain a good working knowledge of applicable Country
• Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non clinical/clinical aspects of project implementation, execution, and closeout
• Excellent English language and grammar skills and proficient local language skills as needed
• Effective presentation skills
• Excellent computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems
• Ability to successfully complete the organizations clinical training program
• Self-motivated, positive attitude and strong interpersonal skills
• Ability to use problem-solving techniques applicable to constantly changing environment
• Ability to provide constructive feedback and suggest improvements to department processes
• Effective oral and written communication skills, with the ability to communicate effectively with medical personnel
• Good negotiation skills
• Basic medical/therapeutic area and medical terminology knowledge
• Basic knowledge of local health systems
• Excellent customer focus
• Ability to work in a matrix environment
• A proven relationship builder
• An independent thinker
• Ability to manage risk and perform risk escalation appropriately
Working Conditions and Environment:
• Work is performed in an office/ laboratory/clinical/ and/or home office environment with exposure to electrical office equipment.
• Occasional drives to site locations. Potential Occasional travel required.