Program Administrator - Nonclinical Operations

Job Description

Job Description

We are the leading oncology CRO, developing novel treatments for patients that need them most. Our team is fully dedicated to oncology – it is all we do – combining innovation and expertise to quickly move medicines from preclinical development into clinical trials. Adaptive and forward-thinking – we guide our client's therapy through the most critical development milestones from the lab to planning their regulatory and clinical strategy. Our ultimate goal? To help patients.

Position Summary :

The Program Administrator - Nonclinical Operations is a cross-functional position primarily providing support to TD2 IACUC and Nonclinical Operations management teams. The IACUC and Program Administrator acts as IACUC Secretary, aiding IACUC Chair in ensuring all studies conducted agree with regulatory guidance for animal welfare, all proper documentation and processes are followed, and communications with IACUC members. Additionally, this position leads departmental SOP / controlled documentation review process, training compliance tracking, and liaison for QMS system. Other day-to-day activities include scheduling and planning meetings, onboarding support, report review and archiving, data update compilation and formatting, and supporting department management as needed.

Essential Functions :

• Act as IACUC Secretary, including responsibility for all Committee communications, scheduling, agenda and minutes for IACUC meetings, participation in semi-annual program review and facilities inspection, review and maintenance of documentation records, drafting reports and letters to Principal Investigators, OLAW, and IO.
• Support on-site visits and audits from clients and regulatory agencies including, but not limited to, OLAW and AAALAC.
• Prepare, distribute, track, file and archive departmental Controlled Documents in accordance with Company-wide policies and act as departmental expert using company Quality Management Software.
• Lead efforts to ensure onboarding personnel training completion in the required timeframe for all department personnel.
• Work independently with study data on formatting, compiling, graphing, analysis and review of client data and laboratory documentation as needed.
• Support Project Managers on coordination of projects, including preparing study folders, tracking sample management software, and providing additional support as requested.
• Formatting, proofreading, tracking and archiving technical final reports as requested.
• Track internal departmental metrics and assist with the development and implementation of streamlined tracking processes.
• Independently schedule and plan departmental-wide meetings.
• Perform administrative tasks to support Department Management and other team members.
• Perform other duties as assigned.

Job Requirements :

Required Specialized / Technical Skills :

TD2 is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, creed, disability, veteran’s status, gender, sexual orientation, gender identity, or gender expression.

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