We are a dedicated group of scientists, physicians, and businesspeople working together toward one goal: to discover and develop therapies that can unleash the power of the body’s immune system to treat and potentially cure cancer. We are passionate about the work we do every day at Agenus to deliver on the promise of immuno-oncology. If you’re looking for an inspired environment, passionate colleagues, and a culture that nurtures learning, innovation and team success, we invite you to join us.
The Role:
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The Clinical Trial Associate, has a hands-on responsibility for the day-to-day coordination of activities within the clinical trial team. Supports the trial team with the planning, start up, execution and close out of trial activities and deliverables.Support and coordinate activities of clinical teams and programs (all phases) in the field of Immuno-oncology and other therapeutic areas as appropriate. Support the trial teams in the management, planning, and execution of clinical trials, including administrative aspects in the execution and management of clinical trials creating and overseeing tools for tracking of trial status, documentation, etc.
In the Role you will:
- Conducts all tasks in accordance with applicable Company Policies, Guidelines, Quality Documents, Standard Operating Procedures (SOPs), Working Instructions (WIs), and other Guidance and Standards, as well as current Good Clinical Practice (ICH-GCP) and applicable national regulations
- Participates in study start-up, conduct, and closeout activities.
- Drafts and/or assists with the preparation of trial-related documents, tools and templates (start-up forms, ICFs, screening scripts, source documents, study logs).
- Supports trial management activities including taking meeting minutes/providing agendas to the clinical team, tracking screening/enrollment across all sites, and maintaining study status trackers.
- Assembles and/or reviews regulatory packages for trial-related submissions to IRB/IECs.
- Liaises with key members of the trial and project team, both internal and external, including study site investigators and coordinators, monitors/clinical research associates and data managers and Clinical Research Organization (CRO) staff.
- Develop and maintain positive relationships both internal and external to project, including site personnel, CROs, vendors, etc
- Participate in clinical study team meetings, and record, issue and file minutes of study-specific meetings.
- Support the CTL/CTM in collection of pertinent Regulatory documents from initial trial start-up through trial close out.
- Ensure central and site file documentation is appropriately tracked and filed, e.g. TMF. Support the CTL/CTM in ensuring that documentation complies with ICH/GCP and project specific requirements.
- Support the CTL/CTM and liaise with Legal and Finance in the development, execution and maintenance of clinical study contracts and budgets. Report relevant status updates/metrics to the study team as per study-specific requirements.
- Support the CTL/CTM in initiating and tracking IRB/EC submissions, approvals and renewals.
- Work with CMC and Logistical Supply Chain to initiate study drug shipments to and returns from approved sites as approved by CTLs.
- Ensure training (including trial specific) is completed per the required timelines and trial needs.
- Proficient in using financial tools and systems and related functions to create accurate financial documents, as well as troubleshooting as required
- Ensure all financial documentation and back-up is audit ready for inspection at all times
- Responsible for calculation, submission and management of accruals each month
Qualifications, About You:
- Bachelor’s degree preferred in a relevant discipline: scientific, healthcare, etc. or equivalent.
- 0-6 years pharmaceutical or related industry experience a plus; experience not mandatory
- Strong verbal and written communication skills
Agenus is Delighted to Provide you With a Comprehensive Benefits Plan, Including Some of the Following:
- Highly competitive and inclusive medical, dental and vision coverage options
- Flexible Spending Accounts for medical expenses and dependent care expenses
- Flexible Vacation Plan-In a time when we move at the speed of light, what matters most is what we achieve, not how many hours we clock or accrue. We want people to take breaks when they need them most and own their time. Our philosophy at Agenus is that freedom to take this time will lead to clarity, creativity and innovation through rested and refreshed eyes. With our Flexible Vacation Plan, Agenus will not limit the amount of vacation you can take. It will allow you to take the vacation time as you need, while fulfilling your job responsibilities and making meaningful contributions to our mission
- Care.com Memberships
- Education Assistance Program
- 401k match and Financial Planning tools
- Employee Stock Purchase Plans
- Employee Assistance Program
- Catered Lunch
- Free Parking
Our core values
The way we work sets Agenus apart.
We put the patient first
We aspire to change the world, improving the experience and options available for every single cancer patient. The answers are out there, and patients are waiting.
We are bold, and we are one
We believe that the only way to deliver on our goals is to aim high and work as one global team. We look for opportunities to challenge, collaborate with, and support one another. We aim to break conventional standards and perform at extraordinary levels.
We work with integrity, respect and honesty
These three building blocks serve as pillars for how we behave, operate, and execute our mission.
We are a culture of ownership and accountability
We hold ourselves accountable not only for exceptional results, but how we get our results.
We are obsessively curious and deeply committed to learning
We live in a fast-paced environment that requires us to learn at or above the speed of change. We believe that curiosity fuels the desire to create, and learning provides the tools to progress.
We perform at our best every day
Every day counts. We confront insurmountable obstacles, problems and choices with intellect, perseverance and hard work.
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