Clinical Research Associate II

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.

We have an opening for a Clinical Research Associate II

What's in it for you?

Highly competitive salary and quarterly incentive plans
• Generous benefits
• Engaged and supportive team members and leaders that treat each other as professionals
• Challenging oncology protocols for some of the top pharmaceutical companies in the US
• A company that values quality over quantity
• Ability to be part of the full life-cycle of a study
• Opportunity to work closely with internal and external key stakeholders

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:
• 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
• Serious adverse event reports
• Adverse event trends
• Treatment failures
• 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

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 2 years' experience as a Clinical Research Associate with a sound track record in managing clinical trial sites
• Experience in monitoring oncology early phase studies is preferred

Skills and Competencies

• Thorough knowledge of ICH Guidelines and GCP including an understanding of regulatory requirements
• Demonstrable multitasking and execution skills
• Good interpersonal skills, including communication, presentation, persuasion, and influence
• Good organizational 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 effective in developing solutions to those problems
• Effective knowledge of the drug development process and the Theradex organizational structure
• Good communication skills: verbal and written
• Proficient knowledge of Outlook, Word, Excel and PowerPoint; able to utilize remote meeting/teleconferencing platforms (such as Teams, Zoom, WebEx, GoToMeeting) effectively

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 and Canada (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

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.