Senior Clinical Research Associate

Company Overview

Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer.

Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer.

This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing.

Tango’s labs and offices are located at 201 Brookline Avenue, in the vibrant Fenway area of Boston, Massachusetts.

Summary

Summary

Tango has an exciting new opportunity to join our growing Clinical team as our first in-house Clinical Research Associate (CRA). In this role you will be responsible for effective partnership with our full service CRO for their management and oversite of assigned clinical studies to ensure data quality and patient safety in accordance with ICH-GCP guidelines and local regulations, as well as applicable SOPs. You will collaborate with the clinical teams in supporting the day-to-day clinical study activities.

Your Role:

• Partner with our full service CRO in their contracted monitoring of our trials, ensuring compliance, data currency and relationship maintenance with sites
• Conduct site visits (i.e. co-monitoring, re-training, IMVs) to determine protocol and regulatory compliance, and prepare and maintain required documentation
• Develop collaborative relationships with sites and study vendors
• Provide support to the clinical study manager, assist with monitoring visit report review and other aspects
• Develop study-specific monitoring tools to be used by the monitoring team to assist with study data review
• Track enrollment status reports to ensure study sites stay on track to meet enrollment goals
• Provide support for study sites with audits/inspections and preparation/responses and quality issues as needed
• Review outstanding data reports to ensure data collection timelines are met
• Perform Serious Adverse Event reconciliation and work with study sites to resolve discrepancies
• Collaborate with others in a mutually supportive and cooperative manner assisting others when possible, to achieve study and project goals
• Additional duties and responsibilities as required

What You Bring:

• Bachelor's degree required with 6 years industry experience in clinical trials
• At least 3 years’ monitoring experience
• At least 2 years’ oncology monitoring experience
• Experience supporting multiple complicated oncology studies simultaneously
• Proven ability to develop relationships with investigator sites and vendors
• Strong written and verbal communication skills and experience conducting presentations and trainings
• Ability to interact both internally and with sites in a collaborative manner with solutions-oriented problem-solving skills
• Excellent working knowledge of ICH/GCP and relevant regulations
• High attention to detail with a focus on quality and compliance in all aspects
• Ability to travel as needed, up to 50%
• Experience with Microsoft Office suite, EDC, CTMS, eTMF and other technologies

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We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.