Theradex Systems, Inc.
Clinical Research Associate (CRA) All levels (I/II/Senior)
Theradex Systems, Inc., Princeton, New Jersey, us, 08543
Theradex Systems, Inc.
Theradex is an Equal Opportunity Employer.
Location: US-NJ-Princeton | US
ID
2025-1409
Category
Clinical Research Associates (Commercial)
Type
Full Time
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.
Clinical Research Associate (CRA) All levels (I/II/Senior) We are expanding our team and are looking to hire CRAs for onsite and remote monitoring of phase l‑lll oncology studies.
Primary responsibilities of this position include, but are not limited to, the following: Conduct Site Monitoring:
Site Qualification visits
Site Initiation visits
Routine Monitoring visits
Close-out visits
All aspects of site management as described in the study plans
Source document verification:
Verify patient eligibility
Reviews consent process for each subject (Informed Consent Form and source documentation)
Assess protocol compliance and deviations
CRF review and data corrections
IMP accountability
Maintenance of on-site investigator files
IEC/IRB documentation
Local laboratory documentation
Maintenance of investigational supplies
Identify and assess safety issues and reporting (SAEs/AEs)
Site Management:
Ensure protection of participants and participants' rights
Proactively identify and resolve actual and potential site and study issues
Ensure clinical data integrity and adherence to study timelines
Clinical Review of individual patient listings
Assist in the preparation of project specific materials e.g., status reports, newsletters, templates, etc.
Act as the routine liaison between study site and the project team for study related issues
Perform other duties as assigned by management
What You Need Level of Education:
At minimum, Bachelor's degree in biological or science-related field (BSc, BA, or RN equivalent) or equivalent experience
Prior Experience:
As a Clinical Research Associate with experience managing clinical trial sites. The number years and type of monitoring experience will determine CRA level.
Experience in monitoring early phase oncology studies is preferred
Skills and Competencies:
Understanding of ICH/GCP Guidelines, and Regulatory requirements
Develop and maintain knowledge related to cancer therapy, clinical trial design and conduct, and drug development process through work experience, literature reviews and other educational opportunities.
Proficient in use of Excel, PowerPoint, Word, and Outlook
Proficient in utilizing remote meeting/teleconferencing platforms effectively
Good organizational skills, including efficiency, punctuality, and collaboration in a team environment.
Good communication skills: verbal and written
Good interpersonal skills including presentation, persuasion, and influence
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 preferred
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 our CRA positions range from $75,000-$145,000 with bonus potential. We will assess the specific title and level of entry during the interview and assessment process since 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 not accepting assistance from search firms for this employment opportunity.
#J-18808-Ljbffr
Theradex is an Equal Opportunity Employer.
Location: US-NJ-Princeton | US
ID
2025-1409
Category
Clinical Research Associates (Commercial)
Type
Full Time
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.
Clinical Research Associate (CRA) All levels (I/II/Senior) We are expanding our team and are looking to hire CRAs for onsite and remote monitoring of phase l‑lll oncology studies.
Primary responsibilities of this position include, but are not limited to, the following: Conduct Site Monitoring:
Site Qualification visits
Site Initiation visits
Routine Monitoring visits
Close-out visits
All aspects of site management as described in the study plans
Source document verification:
Verify patient eligibility
Reviews consent process for each subject (Informed Consent Form and source documentation)
Assess protocol compliance and deviations
CRF review and data corrections
IMP accountability
Maintenance of on-site investigator files
IEC/IRB documentation
Local laboratory documentation
Maintenance of investigational supplies
Identify and assess safety issues and reporting (SAEs/AEs)
Site Management:
Ensure protection of participants and participants' rights
Proactively identify and resolve actual and potential site and study issues
Ensure clinical data integrity and adherence to study timelines
Clinical Review of individual patient listings
Assist in the preparation of project specific materials e.g., status reports, newsletters, templates, etc.
Act as the routine liaison between study site and the project team for study related issues
Perform other duties as assigned by management
What You Need Level of Education:
At minimum, Bachelor's degree in biological or science-related field (BSc, BA, or RN equivalent) or equivalent experience
Prior Experience:
As a Clinical Research Associate with experience managing clinical trial sites. The number years and type of monitoring experience will determine CRA level.
Experience in monitoring early phase oncology studies is preferred
Skills and Competencies:
Understanding of ICH/GCP Guidelines, and Regulatory requirements
Develop and maintain knowledge related to cancer therapy, clinical trial design and conduct, and drug development process through work experience, literature reviews and other educational opportunities.
Proficient in use of Excel, PowerPoint, Word, and Outlook
Proficient in utilizing remote meeting/teleconferencing platforms effectively
Good organizational skills, including efficiency, punctuality, and collaboration in a team environment.
Good communication skills: verbal and written
Good interpersonal skills including presentation, persuasion, and influence
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 preferred
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 our CRA positions range from $75,000-$145,000 with bonus potential. We will assess the specific title and level of entry during the interview and assessment process since 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 not accepting assistance from search firms for this employment opportunity.
#J-18808-Ljbffr