Clinical Research Associate

Who We Are

Celebrating 40+ years!

Theradex Oncology is a full-service CRO specializing in oncology. The company manages global oncology trials and programs. The company was founded in 1982 working with the National Cancer Institute, which led to its expansion to working with industry sponsors developing cancer therapeutics. As a service-based company we support both domestic and international sponsors in the conduct of both early and late phase trials.

What You'll Do

As part of Theradex Oncology, you will have the opportunity to work with one of the largest professional teams focused solely on the development of cancer therapies. Cancer research continues to evolve as new therapies and therapeutic approaches are discovered, as part of the team you will the work to support our sponsors in the development of these therapies. Theradex Oncology is an environment for highly motivated individuals who want to make a difference.

Opportunity

Clinical Research Associate (Entry-Level)

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

• Complete all company-specific trainings within assigned timelines.
• Successful completion of provided CRA Trainee course within 6 months of employment start.
• Provide administrative support to project managers, clinical research associates, and functional area leads during the CRA Trainee period.
• Support day-to-day operations of assigned projects.
• Assist in the preparation of project specific materials e.g., status reports, newsletters, templates, etc.
• Complete project administration tasks such as preparing binders, start-up packs, and other necessary materials.
• Maintain an awareness of the literature on cancer therapy, clinical trial design and conduct, and good clinical practice.

Collaboration & Regulatory Readiness

• Work in collaboration with on-site CRAs to meet Sponsor, Protocol and Theradex objectives of Regulatory Readiness including contract and budget negotiations, as required.
• Communicate regularly with study sites by providing updates and support, and inform the project team of site-related issues.
• Ensure site communications are documented and archived as per project requirements and Theradex Oncology SOPs.

File Preparation & Maintenance

• 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).

Essential Regulatory Documentation Management

• 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.
• Verify Site Essential Documentation before uploading to the eTMF.
• Performs quarterly QC of each study in the eTMF according to Theradex Oncology SOP.
• Track study progress using the CTMS, investigator site file tracker, and sponsor systems to ensure study files remain 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.

Site Visit Activities

• Conducts pre-qualification, initiation, routine monitoring, remote monitoring, and close-out visits including source document review, CRF validation, investigator file maintenance, safety event handling, and study compliance assessments.
• Assist with site visit report preparation within study specific timeframe.
• Assist with all aspects of site management as described in the study plans.
• Identify and resolve site and study issues proactively.
• Escalate data quality issues to maintain clinical data integrity.
• Provide support to project management via ongoing project reports and updates.
• Support multiple studies simultaneously and prioritize appropriately to meet business needs to ensure on-time, quality deliverables.
• Perform other duties as assigned by management.

What You Need

Level of Education

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

Prior Experience

• Previous experience with Clinical Research Site Coordination or related fields (i.e. Regulatory Specialist) preferred.

Or

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

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).
• 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 (for EU/UK) preferably at least one other European language, as applicable.

What We Offer

At Theradex we offer a supportive culture that puts people first. Our employees are eligible to participate in our comprehensive benefits package which includes medical, dental and vision coverage; life insurance, disability insurance (STD/LTD), company matched 401(k), very competitive tuition reimbursement, generous vacation/sick plans, flexible work schedules, employee discounts and other company provided benefits. The annual base salary for this position ranges from $75,000 - $90,000. The actual salary offer will be based on a number of factors, including but not limited to the candidate’s qualifications, experience, skills, and competencies for the role.

This position is not eligible for company provided sponsorship or relocation.

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

Theradex is an Equal Opportunity Employer.