Clinical Research Associate (Entry Level)

Celebrating 40 years!

Theradex Oncology is a full-service CRO, conducting early and late-phase oncology trials in the U.S, Europe and Asia. Theradex Oncology was founded in 1982, when we were awarded the Clinical Trials Monitoring Contract for the National Cancer Institute (NCI). Our ongoing association with NCI continues to be a strong basis for our operations. Our focus is cancer. We fully understand the science behind each potential cancer therapy and the challenges that come with moving therapies from mice to man. 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.

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 simultaneously
• must prioritize appropriately to meet business needs to ensure on-time, quality deliverables.
• Perform other duties as assigned by management.

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.
• Proficient knowledge of 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

• 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 3^rd party contractual obligation requirements.
• Fluent in English

What We Offer

We offer a supportive culture that puts people first. We provide a competitive compensation 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.