Sr 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

 

Senior Clinical Research Associate (Sr CRA)

We are expanding our team and are looking to hire an experienced Sr CRA with proven onsite monitoring of phase l-lll oncology studies.  

 

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

• Act as the routine liaison between study site and the project team for study related issues.
• Ensures protection of subjects, subjects' rights, and the integrity of data through monitoring of 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
  • Reviews consent process for each subject (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/outcomes
  • Conducts and documents onsite visits/contacts, including:
    • Pre-study visits
    • Initiation visits
    • Routine visits
    • Study completion visits/ Close-out visits
    • Telephone contact
  • Site visit report preparation within study specific timeframe
  • Responsible for all aspects of site management as described in the study plans
• Proactively identify and resolve issues and potential site and study issues.
• Assist with regulatory and study start-up activities including contract and budget negotiations, as required.
• Ensure clinical data integrity and meet study timelines.
• Provide ongoing updates and support to project management.
• Mentor junior members of the team.
• Prepare and deliver staff training sessions.
• Clinical Review of individual patient listings
• Initial clinical review of comprehensive patient data listings
• Initial review of study start-up materials: SOPs, draft CRFs, completion manual, compliance forms, study prompters/calendars
• 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 current knowledge related to cancer therapy, clinical trial design and conduct, and good clinical practice through literature reviews and other educational opportunities.
• 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 science-related field or equivalent experience

 

Prior Experience

• At least 4 years’ experience as a Clinical Research Associate with a sound track record in managing clinical trial sites
• Experience in monitoring oncology phase I-III studies

 

Skills and Competencies

• Thorough knowledge of ICH Guidelines and GCP including an understanding of regulatory requirements.
• Demonstrable multitasking and execu