Clinical Research Associate II, Hamilton Township

Who We Are:
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.

What You'll Do:
CRAII - Homebased

 

Our team is growing! 

 

At Theradex, you aren’t just a number. You are part of a highly engaged team of exceptional and supportive people who pride themselves on quality monitoring, continuous learning, challenge themselves and who reap the rewards of providing first in class monitoring to 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.

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 2 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 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 travel as needed to meet study requirements. Ability to travel up to 50% may involve overnight stays. 

Valid Driver’s License required 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 (written and verbal)

 

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 $90,000-$120,000 with bonus potential. 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 an Equal Opportunity Employer.