Senior Clinical Trial Associate/Clinical Trial Associate

Senior Clinical Trial Associate/Clinical Trial AssociateLocation: RemotePosition Type: ContractSummary of PositionWe are seeking talented and highly motivated Clinical Trial Associates (CTA) to join our client's team, a leading biopharmaceutical company, on a contract basis, with the potential to convert to a permanent position. This role involves managing multiple administrative aspects of clinical trials across all project stages, including study start-up, enrollment, study conduct, and close-out. The successful candidate will be a hands-on clinical trial associate capable of performing quality control of clinical trial documents and assisting with study start-up, conduct, and close-out activities. This individual will be accountable for managing the collection, review, completeness, and quality of the assigned Trial Master File (TMF).Key Responsibilities• Serve as the central contact for the clinical operations team for designated project communications, correspondence, and associated documentation.• Set up and maintain study-specific paper and electronic TMFs.• Perform and oversee Quality Control (QC) reviews of essential study documents and TMF to ensure ongoing inspection readiness and compliance with applicable regulations and Good Clinical Practices.• Track and report the ability to maintain TMF health metrics on an ongoing basis.• Process essential documents and ensure they are correctly filed in the appropriate TMF.• Track and report study metrics, inclusive of start-up, data management, and contracting as needed.• Participate in GxP audits and related clinical operations compliance and inspection readiness activities.• Prepare and track study documents (e.g., contracts, budgets, IRB documentation).• Assist with information gathering, literature searches, and creation of presentations, as needed.• Maintain and oversee tasks performed by CRO related to databases/spreadsheets, as necessary, to facilitate tracking/documentation of departmental activities.• Administer user access and change control within electronic systems.• Assist in User Acceptance Testing (UAT) for all Electronic Data Capture (EDC) needs in regard to Data Management and all Clinical Systems.• Ensure all Systems, including but not limited to EDC, TMF, CTMS, Payments, etc., are best utilized per Quality standards.• Assist with vendor management and associated logistics, as assigned.• Contribute to the creation of presentations for project, departmental, sponsor, and/or business development presentations.• Collaborate with Associate Director, Clinical Operations, Clinical Supply Unit, and QA to manage activities related to Clinical Supplies.• Manage study-related payment procedures.• Provide input for budget development and check monthly costs invoiced based on planned study activities vs actual.• Participate in the completion and review of Request for Proposals (RFPs) in collaboration with Clinical Operations Management.• Organize and/or participate in meetings with CROs and ensure appropriate meeting minutes are prepared and filed in TMF.• Assist CRAs with the preparation, handling, and distribution of Clinical Trial Supplies and maintenance of tracking information.• Assist in creating and implementing departmental SOPs and procedures.Requirements• BS/BA in Life Sciences or equivalent• 3+ years of experience in similar positions in Biotech, Pharmaceutical, or clinical research organization environment• Extensive experience managing paper and electronic TMF, including set-up, maintenance, QC/QR, and query management.• Familiarity with the DIA reference model• Knowledge of ICH/GCP and applicable regulations• Demonstrated proficiency in written, verbal, and face-to-face communication to effectively present information and influence decision-making• Ability to manage multiple tasks and resources concurrently while maintaining attention to detail and responding to rapidly changing priorities• Proficient in MS Office (Word, Excel, Project), Adobe, and ISI Toolbox• Strong critical thinking, organizational, and time-management skills• Ability and willingness to travel (up to 10% of the time)Your Path to Unique OpportunitiesIf you’re looking to push the envelope and join an innovative company where technology meets therapeutic discovery and development and you’re enthusiastic, creative, with a passion for cutting-edge research, you should join our client's team! We are looking for highly motivated, passionate employees to help us drive technology solutions for discovering breakthrough treatments for our portfolio of rare disease and neuroscience programs.