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 Sr. Clinical Research Associate (Sr. CRA) will be responsible for performing investigative site management and monitoring activities throughout the clinical trial lifecycle on behalf of our sponsors. 

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
• Conduct pre-qualification, initiation, routine monitoring and close-out visits in accordance with the relevant SOPs.
  • 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
  • Conducts and documents onsite visits/contacts, including:
    • Pre-study visits
    • Initiation visits
    • Routine visits
    • Study completion 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.
• Function as a lead monitor for assigned projects, as required
• Perform Assessment and Training Visits
• 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 an awareness of the literature on cancer therapy, clinical trial design and conduct, and good clinical practice.
• Perform other duties as assigned by management

Requirements

• At minimum, Bachelor's degree (BSc, BA, or RN equivalent) from an accredited institution in biological or science-related field or equivalent 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 early phase studies

Skills and Competencies

• Thorough knowledge of ICH Guidelines and GCP including an understanding of regulatory requirements.
• Highly effective multitasking and execution skills.
• Excellent interpersonal skills, including communication, presentation, persuasion, and influence.
• Excellent organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Knowledgeable in the identification, anticipation, and reporting to appropriate management problems relating to study conduct, and highly effective in developing solutions to those problems
• Effective knowledge of the drug development process and the Theradex organizational structure
• Strong communication skills: verbal/written
• Proficient knowledge of Outlook, Word and Excel

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.

This job does not offer company sponsorship or relocation assistance.

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. 

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