Note: The job is a remote job and is open to candidates in USA. Sumitomo Pharma America, Inc. is a global pharmaceutical company focused on developing therapies across oncology, urology, women's health, rare diseases, cell and gene therapies, and central nervous system conditions. The Clinical Trial Associate, Study Start-Up supports site start-up activities from site identification through activation, including regulatory submissions, essential document collection, contract tracking, site activation planning, and progress reporting.
Responsibilities
- The SSU CTA supports the collaboration with CPMs, CRAs, Clinical Business Operations, Medical Affairs, study sites, study team and CRO, if applicable, to ensure that site activation is achieved in a timely and efficient manner based on timelines set by the study team and in consideration of local activation process requirements
- Perform general administrative tasks to support team members with clinical trial execution, e.g., development and formatting of documents, review and reconciliation of study- specific information, etc
- Ability to work with timelines and complete tasks according to deadline. Problem solving study-related issues; demonstrating resourcefulness and independence; escalation of issues as needed
- Assists the SSU Manager in generating and updating the study site activation plan across countries and sites based on the study priorities detailing country and site-specific requirements and planned dates
- Supports review of and modifications to the study start-up processes to ensure quality and efficiency
- Assists the SSU Manager in their applicable functions and CROs as applicable with regulatory interactions related to submissions and approval processes across multiple countries
- Collects and maintains essential documentation in compliance with ICH-GCP and ensures filing in TMF
- Tracks budget and contract negotiations/executions in collaboration with CPM, CBO and other relevant stakeholders (i.e., Legal, ClinOps, etc.)
- Assists the SSU Associate Director in producing and collecting site-specific contracts, ICFs and CDAs from country and/or master template
- Supports the SSU Associate Director in communicating site prioritization regarding Study Site Contract completion/execution to meet Study Activation Plan
- Tracks and reports metrics of study site progress towards activation at relevant meetings
- Proactively identifies delays in start-up activities, the risks to the activation plan and supports the SSU Associate Director in developing collaborative mitigation strategies for the study team to implement
- Perform other duties as assigned
Skills
- · Bachelor's degree (scientific or healthcare discipline preferred) or equivalent industry experience
- · Strong Computer skills in Office, Word Excel, Project, Smartsheet, and other applicable applications
- · Ability to work in a fast-paced environment with demonstrated ability to manage multiple competing tasks and demands
- · Excellent communication and interpersonal skills are essential as the CTA interacts with many people of varying levels of responsibility for clinical trial programs
- · Able to collaborate effectively with internal and external study management teams to meet project timelines
- · Excellent writing skills to assist with creation of file notes, team communications, and other documents as assigned
- Primarily remote role with periodic on-site meetings in office. Must be able to travel domestically and internationally as needed
- Fast-paced environment handling multiple demands is involved. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time
- · A minimum of 1 year of related experience is preferred
- · Knowledge and experience with Trial Master Files (TMF) and experience with electronic TMF systems (i.e., Veeva) is preferred
- · Knowledge of Site Start-up activities in clinical research is preferred
Benefits
- Opportunity for merit-based salary increases
- Short incentive plan participation
- Eligibility for the company's 401(k) plan
- Medical, dental, vision, life and disability insurances
- Leaves provided in line with your work state
- Flexible paid time off
- 11 paid holidays
- Additional time off for a shut-down period during the last week of December
- 80 hours of paid sick time upon hire and each year thereafter
- Primarily remote role with periodic on-site meetings in office
Company Overview