Clinical Research Associate

TRIO - Translational Research in Oncology; Dallas (TX); Remote; USD 100,000 - 115,000; Full time

Benefits offered by this job

Competitive salary

3 weeks vacation

Paid personal/sick time

100% health benefits

Flexible working hours

Monthly internet allowance

401(k) with 5% salary contribution

Home office allowance

Luggage allowance

Job summary

TRIO - Translational Research in Oncology is seeking an experienced Clinical Research Associate (CRA) to join our Monitoring Resources team. This full-time remote position supports sites across the Central and Western United States with travel up to 60%.

The ideal candidate has 3+ years oncology CRA/CRC/Research Nurse experience, strong ICH-GCP knowledge, and a science-related Bachelor’s degree. Fluent English and ability to travel are required.

Qualifications

• At least 3 years of oncology CRA/CRC/Research Nurse experience.
• Minimum 1 year monitoring on an early phase trial.
• Phase I monitoring experience is valued.
• Solid tumor trial experience preferred (breast, lung, gastric, ovarian, pancreatic).
• Fluent in English.
• Bachelor’s degree in science-related field.
• Strong knowledge of ICH-GCPs.
• Experience with clinical trial information systems.
• Ability to travel up to 60% on average.
• US work authorization required.

Responsibilities

• Perform data verification of source documents.
• Conduct site visits (pre-study, initiation, monitoring, termination).
• Ensure adherence to FDA, ICH-GCP, and local regulations.
• Ensure implementation of FDA and ICH-GCP guidelines.
• Participate in budget negotiation and follow-up.
• Assist with data validation and query resolution.
• Mentor junior team members as required.
• Ensure collection of regulatory documents.

Skills

Oncology CRA experience

Clinical monitoring

ICH-GCP knowledge

FDA/regulatory knowledge

Travel readiness

Communication skills

Education

Science-related Bachelor's degree

Tools

Clinical trial information systems

Job description

If you are an experienced CRA who is passionate about oncology research and looking to join a highly skilled and knowledgeable team, TRIO could be the place for you!

Translational Research in Oncology (TRIO) is a global academic clinical research organization dedicated to advancing translational cancer research in the clinical trial setting. Our passionate team is committed to providing cancer treatments of the future to the world of today.

TRIO is looking for a Clinical Research Associate (CRA) to join our Monitoring Resources team. This is a full-time, remote position for candidates based in the Central and Western United States and will require travel to clinical trial sites.

Responsibilities

• Performing data verification of source documents;
• Conducting site visits, including pre-study, initiation, monitoring, and termination;
• Confirmingadherence to all FDA, ICH-GCP, and local regulations;
• Ensuring implementation and compliance with FDA, and ICH-GCP guidelines
• Participating in budget negotiation and follow-up where applicable
• Assisting with data validation and query resolution
• Mentoring junior team members as required
• Ensuring the completion and collection of regulatory documents

Qualifications

• A minimum of 3 years of oncology experience as a CRA, Clinical Research Coordinator, and/or Research Nurse;
• Minimum of 1 year monitoring experience on an early phase trial
• Experience monitoring phase I trialswill be valued.
• Experience in solid tumor trials, including breast, lung, gastric, ovarian, and/or pancreatic cancer, is preferred;
• Fluent in English
• Completion of a science-related Bachelor’s degree
• Excellent knowledge of medical terminology and clinical monitoring process
• Strong ICH-GCPs knowledge
• Experience with clinical trial information systems
• Ability to travel up to 60% on average
• Must be legally authorized to work in the United States.

What TRIO Can Offer You

• Competitive salary;
• 3 weeks of vacation plus paid Christmas closure;
• 2 weeks of paid personal/sick time;
• 100% health benefits for you and your family paid by TRIO;
• Flexible working hours;
• Monthly internet allowance;
• 401(k) program with 5% salary contribution;
• Home office allowance;
• Luggage allowance.

If you are ready to take the next step in your oncology clinical research career and contribute to meaningful cancer research, we would love to hear from you!

Pay Range: $100,000 - $115,000.Salary to be influenced (or determined) by the education, experience, location, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data.