Clinical Research Monitor

Company OverviewTango 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.The Tango labs and offices are located at 201 Brookline Avenue, in the Fenway area of Boston, MassachusettsSummaryTango has an exciting new opportunity to join our growing Clinical team as our first in-house Clinical Research Monitor (CRM). 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 support the day-to-day clinical study activities.Your Role:You will partner with our full service CRO in their contracted monitoring of our trials, ensuring compliance, data currency and relationship maintenance with sitesYou will conduct site visits to determine protocol and regulatory compliance, and prepare and maintain required documentationDevelop collaborative relationships with sites and study vendorsProvide support to the clinical study manager, assist with monitoring visit report review and other aspectsDevelop study-specific monitoring tools to be used by the monitoring team to assist with study data reviewTrack enrollment status reports to ensure study sites stay on track to meet enrollment goalsProvide support for study sites with auditsinspections and preparationresponses and quality issues as neededReview outstanding data reports to ensure data collection timelines are metPerform Serious Adverse Event reconciliation and work with study sites to resolve discrepanciesCollaborate with others in a mutually supportive and cooperative manner assisting others when possible, to achieve study and project goalsAdditional duties and responsibilities as requiredWhat You Bring:Bachelor's degree required with 6 years industry experience in clinical trialsAt least 3 years' monitoring experienceAt least 2 years' oncology monitoring experienceExperience managing multiple complicated oncology studies simultaneouslyProven ability to develop relationships with investigator sites and vendorsExcellent working knowledge of ICHGCP and relevant regulationsHigh attention to detail with a focus on quality and compliance in all aspectsAbility to travel as needed, up to 50%Experience with Microsoft Office suite, EDC, CTMS, eTMF and other technologiesWe 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.

Created: 2025-02-22