As a Clinical Trial Associate you will be primarily responsible for developing and supporting the infrastructure of the clinical trial throughout the project lifecycle. You will work 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:

• Participate as an active member of the project team from the hand over meeting from   feasibility team member to  study transfer or closeout.
• Maintain and coordinate logistical aspects of assigned clinical trials according to GCP and ICH relevant SOPs.
• Provide support to the PM in aspects of trial management not limited to the following:
• Creation and distribution of meeting agendas, minutes, decision logs, action item tracking, and slide deck as requested.
• Develop and maintain internal and external study team and site contact lists.
• Build and maintain the study team training tracker. o Produce debarment checks.
• Set up and maintain CTMS or other centralized system. o Organize and request shipments of non-IP supplies.
• Prepare and distribute Investigator Site File binders to clinical sites.
• Maintain trackers for study systems and assist with granting access to appropriate study members.
• Manage post-activation central IRB tasks. o Assist with creation and distribution of monthly status report and site newsletters.
• Responsible or assist with SUSAR distribution and Ethics Committee (EC) submissions.
• Ability to execute the technical aspects of all sites’ regulatory documentation and  compliance during the  conduct  of clinical research studies as needed.
• Assist cross-functional central site services teams to update feasibility and study start up trackers as well as review essential document packages to meet start up timelines.
• Address any issues in a timely and responsible manner and put control measures in place to prevent recurrences 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.
• 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.
• 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.
• Participate in authoring/reviewing job aids, manuals, guidance documents and training materials.

• Project Oversight and KPIs:
• Track and report on eTMF KPIs
• Responsible for oversight of the filing and quality control of the Trial Master
• File by all functional areas throughout the lifecycle of the project.
• Coordinate the eTMF reconciliation process and eTMF Transfer deliverables for the study team
• Assess and report on eTMF document management status, performance metrics, issues and lessons learned to  appropriate parties.
• Responsible for managing all activities associated with the TMF services for which Catalyst is contracted,  developing best practice guidelines, and overseeing project team compliance.

• Process Development:
• Contribute to SOP and JA updates and development as needed.
• Participate in or manage non-study related projects or initiatives as needed.
• Manage and oversee process implementation and collect feedback as needed.

• QA and Study Audit Responsibilities:
• Responsible for ensuring that project documentation is complete and audit ready.
• Participate in the audits. ·
• Address questions in the audit reports.
• Support study audits and respond to audit reports.

• Additional for South Korea - based employees:
• May Collect, develop and review of the IRB specific package per site and submit to each IRB
• May prepare and submit SUSARs and safety information to each IRB
• May assist IRB queries received within the requested timelines; manage the portal applications.
• May prepare and complete any study related document amendments to each IRB
• May assist study feasibility and site contract negotiation with site staff
• Assist for any Import License and Export License applications, when required, if applicable for the country per  protocol and country requirements.
• Assist development of Ancillary Budget and Contract templates, when needed (e.g., Laboratory, Pharmacy, Radiology) and perform ancillary contracted negotiations with the external/internal facilities and track the  negotiation progress.

Position Qualifications/Requirements:

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

Experience: Prefer basic clinical development and business experience familiar with the clinical and study management operational requirements. Experience with Good Clinical Practices preferred. At least 1 year of  clinical research document management experience.

Required Certifications: N/A

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.
• 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.
• Team player and proactive problem solver.
• Exceptional written and verbal communication skills.
• Ability to read, write and speak fluent English.
• Familiarity with Microsoft Outlook and business email etiquette.
• Good working knowledge of a range of computer applications.
• Proficient in Microsoft office (Word, Excel, PowerPoint, Teams, SharePoint).
• Occasional travel to closest Catalyst or Sponsor office, as needed