Translational Research in Oncology Hiring for CRA Line Manager at Remote Full Time

If you are an experienced CRA Lead who is passionate about oncology research and looking to join a highly skilled and knowledgeable team, TRIO is 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 CRA Line Manager to join our Monitoring Resources team. Reporting to the CRA Manager, this position will be home-based in the USA.

Responsibilities:

• Supervise assigned Clinical Research Associates (CRAs) to ensure monitoring activities are performed as per requirements (ICH GCPs, local regulatory requirements, TRIO SOPs, trial protocols, timelines and budget), for multiple trials.
• Oversee all trial-related monitoring activities performed by the CRAs.
• Compile monitoring metrics and key performance indicators for the CRAs.
• Communicate regularly on project status to Senior Managers, Project Management and the Sponsor (if applicable) to ensure project goals are met.
• Proactively identify, escalate or resolve monitoring issues, as appropriate.
• Participate in the selection of internal and external CRAs.
• Coordinate site hand-over process between 2 CRAs as per TRIO or sponsor procedures
• Perform CRA assessment visits, as per TRIO SOP, as required.
• Responsible for ensuring timely site audit report reply (MR part). Responsible for implementation of/ follow-up on corrective actions/preventive actions, when appropriate.
• Ensure timely follow-up on oversight visit findings by the CRAs.
• Prepare and conduct trial-specific calls for Third-Party Organization (TPO) or TRIO CRAs within an assigned country.
• Participate in process improvement initiatives, as required.

Qualifications:

• Bachelor’s Degree in health fields such as Medical, Nursing, Pharmacy, or Health Science – or its international equivalent.
• A minimum of 5 years of experience in the field as a CRA, oncology knowledge is a major asset.
• Experienced in mentoring and training CRAs in a positive and effective manner
• Excellent knowledge of medical terminology and clinical monitoring process
• Strong ICH-GCPs knowledge
• Ability to prioritize multiple tasks and achieve project timelines
• Must work both independently and in a team environment.
• Excellent verbal and written communication skills and attention to details with an ability to work in a multi-cultural environment
• Read, write and speak fluent English
• Ability to travel up to 30% on average

What TRIO Can Offer You:

• 3 weeks of vacation plus paid Christmas Closure
• 2 weeks paid personal/sick time
• Competitive salary
• 100% health benefits for you and your family paid by TRIO
• Flexible working hours
• Monthly internet allowance
• 401K Program 5% Salary Contribution
• Home office allowance

Health & Safety:

TRIO is committed to creating a safe and healthy environment for everyone. As part of this commitment, TRIO has implemented a COVID 19-Vaccination Policy. Employees must be fully vaccinated against COVID-19 and provide proof of vaccination. Employees who cannot be fully vaccinated on the basis of a protected legal ground (e.g. medical) may request an exemption. Please note that this policy applies to all employees, including new hires, and contractors. If your application is successful, you will be asked to provide proof of vaccination or request an exemption.

All interviews are currently being conducted virtually – via phone or video. We thank all candidates for their interest; only those selected for an interview will be contacted.

Integrity • Teamwork • Passion

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