Who We Are:
Theradex Oncology has designed and performed more than 350 early-phase oncology trials to date. As a full service CRO, Theradex Oncology knows how to assist its clients in developing successful strategies and execute studies in cancer treatment. Our mission is to ensure that new opportunities in drug development have the very best chance to be of benefit to mankind, with a vision to make cancer a livable disease. With 42 years of experience focused entirely on oncology, we are passionate specialists. We understand the science behind each potential cancer therapy and the challenges that come with moving therapies from mice to man. Our head office is based in Princeton, NJ, USA, while our European operations are managed from our London office.
What You’ll Do:

LEVEL OF EDUCATION

• At minimum, Bachelor’s degree (BSc, BA, or RN equivalent) in biological or human science-related field or equivalent experience.
• Oncology knowledge / PhD preferred

PRIOR EXPERIENCE

• Previous experience with Clinical Research Site Coordination or related fields (i.e. Regulatory Specialist) preferred.
• Previous experience in monitoring (i.e. In-House CRA/CTA/CMA) or equivalent experience) preferred.
• Study Start up experience is an advantage

SKILLS AND COMPETENCIES

• Professional attitude with good customer focus.
• Strong communication skills: verbal/written/presentation.
• Good interpersonal skills, including persuasion and influence.
• Able to work independently as well as in a group.
• Good time management, multitasking and execution skills.
• Good organizational skills, including efficiency, punctuality, and collaboration in a team environment.
• Demonstrated proficiency in Microsoft Outlook, Word, and Excel.
• Technically proficient enough to work in a remote environment and able to address minor technical challenges without support but will timely escalate to Information
• Technology Support for challenges beyond capabilities.
• Capable of absorbing and applying knowledge gained through internal and external trainings on protocols assigned.
• Knowledge of ICH Guidelines and GCP including an understanding of regulatory requirements.
• Effective knowledge of the drug development process and the Theradex organizational structure

ADDITIONAL REQUIREMENTS

• This position involves international and/or national travel as needed to meet study requirements. Ability to travel domestically and/or internationally and may involve overnight stays. Travel requirements are up to approximately 50% in the US (where remote monitoring is allowed) and up to 70% for all other areas (EU, UK, etc.)
• Valid Driver’s License and Passport preferable.
• Successfully pass background clearance checks which may be run on a periodic basis due to 3rd party contractual obligation requirements.
• Fluent in English and Italian.

• The primary responsibilities of this position include, but are not limited to, the following:
• Complete all company specific trainings timely once assigned.
• Successful completion of provided CRA Trainee course within 6 months of employment start.
• Act as administrative support to PMs, CRAs and functional area leads during CRA Trainee period.
• Assist in the day to day running of projects assigned.
• Assist in the preparation of project specific materials e.g., status reports, newsletters, templates, etc.
• Participate in project administration as required e.g., photocopying, binder preparation, start-up pack preparation etc.
• Maintain an awareness of the literature on cancer therapy, clinical trial design and conduct, and good clinical practice.
• Work in collaboration with on-site CRAs to meet Sponsor, Protocol and Theradex objectives of Regulatory Readiness including contract and budget negotiations, as required.
• Assist on routine communications with study sites, providing study updates and support to sites and providing project team updates on site related issues.Ensure site communications are documented and archived as per project requirements and Theradex Oncology SOPs.
• Responsible for assisting in the preparation of the Investigator and Sponsor files with essential documents for the initiation of sites participating in clinical studies.
• Assist study staff with maintaining the sponsor files during the life of the study.
• Assist in archiving at the end of study in accordance with relevant SOPs, policies and local regulatory.
• Maintain/up-date site information (including all contact details, contracts, and reports).
• Performs ongoing management of essential regulatory documentation at the outset and across the lifespan of a study, such as:
• Essential document collection, review, upload, maintenance, and close-out activities, ensuring that that sponsor and investigator obligations are being met and follow applicable local regulatory requirements and ICH/GCP guidelines.
• Perform Site Essential Documentation verification prior to upload into the eTMF.
• Performs quarterly QC of each study in the eTMF according to Theradex Oncology SOP.
• Performs study tracking via CTMS, investigator site file tracker (if utilized) and/or sponsor designated system to ensure that the study files are current, accurate and complete.
• Ensures protection of subjects, subjects’ rights, and the integrity of data through adherence to Good Clinical Practice, applicable regulatory requirements, Standard Operating Procedures, and protocol compliance.
• Assist in the conduct of pre-qualification, initiation, routine monitoring, remote monitoring, and close-out visits in accordance with the relevant SOPs to include but not limited to:
• Source document review and comparison to CRF data
• CRF review/retrieval and data corrections
• IMP accountability
• Maintenance of on-site investigator files
• IEC/IRB documentation
• Local laboratory documentation
• Maintenance of investigational supplies
• Subject consent and consent process review (Informed Consent Form and source documentation)
• Verify patient eligibility
• Assess protocol compliance and deviations
• Handling of safety and efficacy issues, including, but not limited to:
• Serious adverse event reports
• Adverse event trends
• Treatment failures
• Assist with site visit report preparation within study specific timeframe
• Assist with all aspects of site management as described in the study plans
• Proactively identify and resolve potential site and study issues.
• Identify and escalate data quality issues to ensure clinical data integrity
• Provide support to project management via ongoing project reports and updates.
• May be responsible for supporting multiple studies simultaneousl
• Must prioritize appropriately to meet business needs to ensure on-time, quality deliverables.
• Perform other duties as assigned by management