Senior Clinical Research Associate

Tango Therapeutics•Boston, MA

21d•Onsite

About The Position

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.

Requirements

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

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 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