[ref. g04244721] Clinical Research Associate I

Who We Are:

Celebrating 40+ Years!

Theradex Oncology has designed and managed more than 250 early and late-phase oncology trials to date. Our mission is to assure that new discoveries in cancer drug development have the very best opportunity to be of benefit to mankind with a vision to improve treatment and make cancer a livable disease.

What You'll Do:

Our team is growing!

At Theradex, you aren’t just a number. You are part of a highly engaged team of exceptional and supportive people who pride themselves on quality monitoring, continuous learning, challenge themselves and who reap the rewards of providing first in class monitoring to our sponsors.

The primary responsibilities of this position include, but are not limited to, the following:

• Provide day-to-day management and execution of projects as assigned.
• Assist in the preparation of project specific materials e.g., status reports, newsletters, training materials, forms/templates, study manuals/binders, visit reports etc.
• Maintain current knowledge related to cancer therapy, clinical trial design and conduct, and good clinical practice through literature reviews and other educational opportunities.
• Collaborate with other members of the project team to meet Sponsor, Theradex and project objectives of site activations (including contract and budget negotiations), regulatory readiness and data quality/cleaning, as required.
• Establish and maintain effective, routine communications with study sites , providing timely study updates and support to sites.
• Ensure site communications are documented and archived as per project requirements and Theradex Oncology SOPs.
• Establish and maintain effective, routine communications with the internal project team, providing timely project team updates on site related issues.
• Responsible for 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-to-date site information (including all contact details and distribution lists for reports and clinical supplies).
• Performs ongoing management of essential regulatory documentation at the outset and across the lifespan of a study
• 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 or routine QC of assigned studies/sites in the eTMF according to Theradex Oncology SOP.
• Performs study tracking via the study’s 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.
• Conducts pre-qualification, initiation, routine monitoring, remote monitoring, and close-out visits in accordance with the relevant SOPs and the specific project scope of work 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 and document protocol compliance and deviations.
• Identification of safety and efficacy issues, with escalation as appropriate, including, but not limited to
• Serious adverse reports
• Adverse event reporting
• Treatment failures/outcomes
• 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 simultaneously.
• Must prioritize appropriately to meet business needs to ensure on-time, quality deliverables.
• Perform other duties as assigned by management.

What You Need:

• At minimum, Bachelor's degree (BSc, BA, or RN equivalent) in biological or human science-related field or equivalent experience.

• At least 1 year of experience as a Clinical Research Associate (6 months if previously a CRA at Theradex Oncology)
• Successful completion of an approved Clinical Research / Monitoring course.
• Previous experience in monitoring oncology studies is preferred.
• Previous experience with Clinical Research Site Coordination or related fields (i.e. Regulatory Specialist) is preferred.

• Previous experience in monitoring (i.e. In-House CRA/CTA/CMA or equivalent experience) preferred.

• Professional attitude with good customer focus.
• Effective 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, Excel and PowerPoint.
• Appropriate level of technical proficiency to effectively work in a remote environment and able to address minor/common 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 understanding of the drug development process and the Theradex organizational structure.

• This position involves travel as needed to meet study requirements. Ability to travel up to 50% may involve overnight stays.
• Valid Driver’s License required and Passport preferable
• Successfully pass background clearance checks which may be run on a periodic basis due to 3^rd party contractual obligation requirements.
• Fluent in English (verbal and written)

What we offer

We offer a supportive culture that puts people first. We provide a competitive compensation, CRA incentive plan and benefits package including medical, dental, vision, life insurance, STD/LTD, company matched 401(k), very competitive tuition reimbursement, generous vacation/sick plans, flexible work schedules, employee discounts and much more.

Theradex is an Equal Opportunity Employer.

Theradex is not accepting assistance from search firms for this employment opportunity.