Tango Therapeutics is seeking to discover novel drug targets and deliver the next generation of precision medicine for the treatment of cancer. The company needs a Clinical Research Associate to manage and oversee clinical studies, ensuring data quality and patient safety.
Requirements
- At least 3 years’ monitoring experience
- At least 2 years’ oncology monitoring experience
- Experience supporting multiple complicated oncology studies simultaneously
- Excellent working knowledge of ICH/GCP and relevant regulations
- Experience with Microsoft Office suite, EDC, CTMS, eTMF and other technologies
Responsibilities
- 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 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
- Review outstanding data reports to ensure data collection timelines are met
- Perform Serious Adverse Event reconciliation and work with study sites to resolve discrepancies
- Provide support for study sites with audits/inspections and preparation/responses and quality issues as needed
Other
- Bachelor's degree required with 6 years industry experience in clinical trials
- 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
- High attention to detail with a focus on quality and compliance in all aspects
- Ability to travel as needed, up to 50%
