Real Staffing
Sr. Clinical Trial Associate
Real Staffing - Cambridge, Massachusetts, us, 02140
Work at Real Staffing
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Overview
Sr. Clinical Trial Associate
Purpose of Position:
The primary role of the Sr. Clinical Trial Associate (Sr. CTA) is to support the clinical operations team by managing administrative tasks, thereby ensuring efficient study management and compliance with regulatory standards. Provide comprehensive administrative support to facilitate the management of company-sponsored clinical studies Execute a variety of critical tasks as directed by the Clinical Project Manager (CPM), including study budget forecasting and tracking. Manage the collection, tracking, and reporting of research-related Transfer of Value (TOV) to comply with Transparency reporting requirements in the US and EU Ensure that all study documentation, such as trial master files, contracts, and financial records, are processed and maintained in accordance with ICH-GCP, company policies, and regulatory requirements. This includes managing communications and resolving documentation issues with service providers concerning e-TMF processes. Conduct quality control checks on Trial Master Files (TMFs) to guarantee their completeness and readiness for audits or inspections. Actively participate in initiatives aimed at achieving clinical trial excellence. Responsibilities:
Clinical Trial Master File (TMF) Management:
Oversee the setup, monitoring, verification, and archiving of the Clinical Trial Master File (TMF). Administer both electronic and paper TMF systems, ensuring their integrity and accessibility. Facilitate the creation and setup of clinical study binders for country and site operations, aligning with trial milestones. Customize and prepare TMF oversight plans, management plans, and master indexes in collaboration with CRM/CPM and document owners, tailoring these to the specific needs of the clinical study. Communicate changes in study team composition, such as new members joining or existing members leaving, to maintain an updated roster. Maintain the TMF with up-to-date, essential documents and ensure they are filed correctly. Continuously oversee TMF activities conducted by the CRO/Company, ensuring document consistency and adherence to SOP timelines, and report the oversight status to relevant study team members. Coordinate TMF Quality Checks as per SOP with the CRO/Company to ensure the eTMF is always ready for inspection. Manage the final TMF reconciliation process with the CRM/CPM at the conclusion of the study. Handle the archiving of the TMF upon study completion. Financial Management:
Manage the creation and updating of financial records within the internal K2 system, including Internal Orders, Purchase Orders, goods receipts, and invoices, ensuring accurate financial tracking and reporting. Initiate and monitor clinical study Commitment Requests using the dedicated K2 tool. Develop and maintain specific clinical study budget trackers to provide clear visibility on financial status and allocations. Review and analyze invoices in comparison to CRO/Vendor contracts and study progress, making informed recommendations to the CRM/CPM regarding approval. Required Experience and Qualifications:
The ideal candidate for the Sr. Clinical Trial Associate position should have: A minimum of 3 to 5 years of experience as a CTA, preferably within a CRO or pharmaceutical company environment. Proven expertise in navigating clinical study environments and managing Veeva Vault systems. Familiarity with specialized internal tools, with comprehensive training provided during the on-boarding process. A strong foundation in the administrative organization of clinical studies, with a scientific background considered a significant asset. Background in oncology / large global phase III studies is highly preferred Able to commute at least 2-3 times per week (Hybrid) Education:
Ideal: A 3-year degree in a scientific, clinical, or research field with at least 1 year of relevant work experience in clinical research/study management. Minimum: A 2-year degree in a relevant scientific field with a minimum of 2 years of experience in a clinical research/study management setting. The right candidate should be energetic, curious, proactive, capable of raising pertinent questions, and a self-starter. EOE Statement:
Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. To find out more about Real, please visit
www.realstaffing.com
#J-18808-Ljbffr
Purpose of Position:
The primary role of the Sr. Clinical Trial Associate (Sr. CTA) is to support the clinical operations team by managing administrative tasks, thereby ensuring efficient study management and compliance with regulatory standards. Provide comprehensive administrative support to facilitate the management of company-sponsored clinical studies Execute a variety of critical tasks as directed by the Clinical Project Manager (CPM), including study budget forecasting and tracking. Manage the collection, tracking, and reporting of research-related Transfer of Value (TOV) to comply with Transparency reporting requirements in the US and EU Ensure that all study documentation, such as trial master files, contracts, and financial records, are processed and maintained in accordance with ICH-GCP, company policies, and regulatory requirements. This includes managing communications and resolving documentation issues with service providers concerning e-TMF processes. Conduct quality control checks on Trial Master Files (TMFs) to guarantee their completeness and readiness for audits or inspections. Actively participate in initiatives aimed at achieving clinical trial excellence. Responsibilities:
Clinical Trial Master File (TMF) Management:
Oversee the setup, monitoring, verification, and archiving of the Clinical Trial Master File (TMF). Administer both electronic and paper TMF systems, ensuring their integrity and accessibility. Facilitate the creation and setup of clinical study binders for country and site operations, aligning with trial milestones. Customize and prepare TMF oversight plans, management plans, and master indexes in collaboration with CRM/CPM and document owners, tailoring these to the specific needs of the clinical study. Communicate changes in study team composition, such as new members joining or existing members leaving, to maintain an updated roster. Maintain the TMF with up-to-date, essential documents and ensure they are filed correctly. Continuously oversee TMF activities conducted by the CRO/Company, ensuring document consistency and adherence to SOP timelines, and report the oversight status to relevant study team members. Coordinate TMF Quality Checks as per SOP with the CRO/Company to ensure the eTMF is always ready for inspection. Manage the final TMF reconciliation process with the CRM/CPM at the conclusion of the study. Handle the archiving of the TMF upon study completion. Financial Management:
Manage the creation and updating of financial records within the internal K2 system, including Internal Orders, Purchase Orders, goods receipts, and invoices, ensuring accurate financial tracking and reporting. Initiate and monitor clinical study Commitment Requests using the dedicated K2 tool. Develop and maintain specific clinical study budget trackers to provide clear visibility on financial status and allocations. Review and analyze invoices in comparison to CRO/Vendor contracts and study progress, making informed recommendations to the CRM/CPM regarding approval. Required Experience and Qualifications:
The ideal candidate for the Sr. Clinical Trial Associate position should have: A minimum of 3 to 5 years of experience as a CTA, preferably within a CRO or pharmaceutical company environment. Proven expertise in navigating clinical study environments and managing Veeva Vault systems. Familiarity with specialized internal tools, with comprehensive training provided during the on-boarding process. A strong foundation in the administrative organization of clinical studies, with a scientific background considered a significant asset. Background in oncology / large global phase III studies is highly preferred Able to commute at least 2-3 times per week (Hybrid) Education:
Ideal: A 3-year degree in a scientific, clinical, or research field with at least 1 year of relevant work experience in clinical research/study management. Minimum: A 2-year degree in a relevant scientific field with a minimum of 2 years of experience in a clinical research/study management setting. The right candidate should be energetic, curious, proactive, capable of raising pertinent questions, and a self-starter. EOE Statement:
Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. To find out more about Real, please visit
www.realstaffing.com
#J-18808-Ljbffr