[Remote] Clinical Trial Associate, Study Start-Up
Note The job is a remote job and is open to candidates in USA. reputed company. is a global reputed 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 reputed company 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, reputed company, 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 reputed company reputed company (TMF) and experience with electronic TMF systems (i.e., reputed company) 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 reputed company) is a science-based, technology-driven biopharmaceutical company focused on delivering therapeutic and scientific breakthroughs in areas of critical patient need in oncology, urology, women’s health, rare disease, cell and gene therapies and CNS. It was founded in 2023, and is headquartered in Marlborough, Massachusetts, US, with a reputed company of 1001-5000 employees. Its website is . Apply To This Job
