Remote Clinical Trial Associate

As a Clinical Trial Associate (CTA) you would be primarily responsible for developing and supporting the infrastructure of the clinical trial throughout the project lifecycle.  The CTA works directly with the Site Activation Manager (SAM), Project Manager (PM), Clients, vendors, and other internal functional teams to ensure quality deliverables on-time and on-budget. Our mission is for our Catalyst staff to operate seamlessly with our customer teams using the Catalyst site centric model to enhance employee satisfaction while giving the sites and customers the reassurance that they have a strong, experienced team in all functional areas.

Position Responsibilities/Accountabilities:

• Participates in the hand over meeting from feasibility team member.
• Maintenance and coordination of the logistical aspects of clinical trials according to GCP and ICH relevant SOP’s.
• Act as a primary contact for the clinical trial team supporting the PM.
• Ability to execute the technical aspects of all sites regulatory documentation and compliance during the conduct of clinical research studies as needed.
• Participation as an active member of the project team.
• Assists PM with project related meetings including agendas, decision logs and action item tracking, as needed.
• Assess and put in place action plans to ensure project deliverables are met according to agreed timelines and milestones and quality expectations.
• Supports implementation of technology enabled processes and identifies new technology solutions to improve overall efficiency within the Clinical Operations group
• Responsible for oversight of the filing and quality control of the Trial Master File by all functional areas throughout the lifecycle of the project
• Develops effective and productive partnerships with strategic business partners as well as client team members to ensure clarity of role, deliverables and achievement of project goals and objectives.
• Self-directed in task execution to ensure project deliverables are met.
• Proactive problem solver who either solves issues on their own or raised them to the appropriate level of management to facilitate a solution.
• Works closely with Sponsors under the direction of the PM in support of project services being delivered.
• Maintains quality control and quality assurance process for project support, liaising with sponsors as necessary to obtain and investigate feedback on quality and turnaround times.
• Address any issues in a timely and responsible manner and put control measures in place to prevent recurrences.
• Responsible for maintaining CTMS for assigned projects, tracking all information and production of status reports for project team and sponsors, as needed.
• Supports the PM in the forecasting and ordering all clinical trial supplies.
• Responsible for ensuring all study documents are archived based on the appropriate guidelines/policy.
• Responsible for understanding the CSS budget on each project and the actions required to maintain it.
• Contribute to development and improvement of quality processes.
• Assist with the compilation of the Clinical Study Report appendices
• Mentor, train and oversee other CTAs to ensure adherence to processes and study deliverables.
• Participate in or manage non-study related projects or initiatives.
• Participate in authoring/reviewing job aids, manuals, guidance documents and training materials.
• Manage and oversee process implementation and collect feedback.
• Responsible for managing all activities associated with the TMF services for which Catalyst is contracted, developing best practice guidelines, and overseeing project team compliance.
• Act as a Subject Matter Expert (SME) or Super User for Catalyst systems or client systems, as needed.

Position Qualifications/Requirements:

Education:  Associates degree (or equivalent) or comparable industry experience.

Experience:  2 years of experience working as a CTA at a CRO

Required Skills:

• Strong organizational skills
• Technical capabilities in computers, software packages (PowerPoint, Excel, Access, Project, Publisher, Visio), Clinical Trial Management Systems (CTMS) and Trial Master Files (TMF)
• Excellent written and verbal capabilities that facilitate internal and external communications.
• Ability to multi-task across a broad set of tasks without direct supervision on a daily basis.
• Self-motivation and direction in alignment with the overall company goals and objectives.
• Exercises sound judgment and problem solving in situations where there is limited information directing the solution to the problem.

Physical Demands: Sedentary work that primarily involves sitting/standing

Employee may be office or remote based.