Senior Clinical Research Associate

TRIO - Translational Research in Oncology; Dallas (TX); Remote; USD 110,000 - 132,000; Full time

Benefits offered by this job

Health benefits for you and family (TR

Vacation time

Personal/sick time

401(k) with employer matching

Home office allowance

Internet allowance

Luggage allowance

Flexible working hours

Job summary

TRIO - Translational Research in Oncology is seeking a Senior 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 include site visits, ensuring FDA/ICH-GCP compliance, managing regulatory documents, data verification, and mentoring junior CRAs.

Qualifications

• Minimum 5 years oncology experience as CRA/CRC/Research Nurse.
• Minimum 2 years monitoring on early phase trials.
• Phase I trial monitoring experience preferred.
• Experience in solid tumor trials (breast, lung, gastric, ovarian, pancreatic).
• Fluent in English; science-related Bachelor's degree.
• Strong ICH-GCP knowledge and trial processes.
• Experience with clinical trial information systems.

Responsibilities

• Conduct site visits (pre-study to termination).
• Ensure FDA/ICH-GCP compliance and regulatory document completion.
• Perform data verification of source documents.
• Ensure FDA/ICH-GCP guideline adherence.
• Assist with budget negotiations and follow-up where applicable.
• Mentor junior CRAs on-site.

Skills

Oncology CRA experience

Monitoring experience

Phase I monitoring

Solid tumor trials

Fluent English

Bachelor's degree

ICH-GCP knowledge

Clinical trial systems

Travel readiness

Mentoring

Education

Science-related Bachelor's degree

Tools

CTMS

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 Senior 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

• Conducting site visits, including pre-study, initiation, monitoring, and termination;
• Confirmingadherence to all FDA, ICH-GCP and local regulations;
• Ensuring the completion and collection of regulatory documents;
• Performing data verification of source documents;
• Ensuring implementation and compliance with FDA, 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.

Qualifications

• A minimum of 5years of oncology experience as a CRA, Clinical Research Coordinator, and/or Research Nurse;
• Minimum of 2year 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
• Ability to mentor and train new/junior CRAs on-site in a positive and effective manner
• 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.

Pay Range: $110,000 - $132,000. 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.