Clinical Trials Associate

Clinical Trials Associate responsible for ensuring the effective and efficient conduct of clinical research studies. The role involves supporting the Clinical Operations team, maintaining clinical study documentation, and facilitating the collection and review of required study documents.

Requirements

• Support the Clinical Operations teams in the completion of all required tasks to meet trial, departmental and project goals.
• Maintain, share and champion a thorough knowledge ICH GCP, appropriate regulations, relevant SOPs and internal tracking systems.
• Collaborate with Clinical Trials Manager (CTM) and Clinical Research Associates (CRAs) to resolve clinical trial documentation issues.
• Establish, organize and maintain clinical study documentation (e.g. Trial Master File, study level and site level documents, etc.)
• Review clinical trial documents to determine compliance with Good Documentation Practices (GDocP), file and track study documents.
• Determine materials and other resources needed to conduct the clinical trial and manage their acquisition and distribution.
• Audit Investigator/Site invoices for accuracy, and reconcile invoices against the case report forms (CRFs) and budget for payment submission.
• Gather central IRB report information, submit the report to the central IRB portal and track the IRB submissions from beginning through approval.
• Facilitate the collection and review of required study documents during site start-up
• Contact clinical sites for specific requests (e.g., enrollment updates, missing documentation, meeting arrangements, etc.)
• Route study documents to the appropriate personnel for validated digital signatures
• Submit purchase requisitions to Enterprise Resource Planning (ERP) System for Clinical Operations functional groups as needed.
• Request invoice approval from internal supplier designee.
• Participate in clinical operations safety reporting activities; distribute, file and track safety reports and IRB submissions.
• Facilitate clinical operations team meeting coordination, agenda preparation and meeting minutes preparation
• Perform ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities.

Benefits

• Medical, Dental and Vision Plan Options
• Health and Financial Wellness Programs
• Employer Assistance Program (EAP)
• Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability
• Healthcare and Dependent Care Flexible Spending Accounts
• 401(k) Retirement Plan with Company Match
• 529 Education Savings Program
• Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks
• Paid Time Off (PTO) includes: 11 Holidays • Exempt Employees are eligible for Unlimited PTO • Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day