Sr. Clinical Trial Associate at Kiniksa Pharmaceuticals
Lexington, MA 02420
About the Job
Reporting to the Associate Director, Clinical Operations, the Senior Clinical Trial Associate (Sr CTA) will be responsible for the daily administrative parts of clinical trials, at all stages of the process along with implementation of clinical operational plans, study specific reports and vendor management activities in accordance with regulatory guidelines and ICH/GCP standards.This role will be based in our Lexington office
Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote.Responsibilities (including, but not limited to):Manage study-related vendors and serving as a point of contact for contracted CROs, study staff and contract labs; identifying potential risks and proactively resolving issues with CROs; establishing vendor management plans and reviewing quality metricsReview monitoring reports, protocol deviations and data listings for studiesCoordinate cross-functional project-related activities (e.g., Clinical Data Review meetings)Coordinate with CROs on site selection, IRB submissions, site initiation and close-out planningLead the development of reports for communicating study progress and key metrics to Senior Management and program teamPerform initial review of invoices against contracted services Assist with budget managementPrepare and provide input to study timelinesDevelop and manage study trackers and provide metrics as neededPerform and/or oversee site monitoring visits for clinical trials as neededEnsure inspection readiness and provide support to sites to prepare for clinical audits/inspectionsEnsure documentation is completed in accordance with GCP regulatory requirements and is consistent with the study protocolsOrganize and prepare study files related to study tracking and reporting and submit to the Trial Master File within established guidelinesQualifications: Requires a Bachelor’s degree with at least 3 years of relevant work experience in a pharmaceutical, academic or CRO environmentWorking knowledge of ICH/GCP regulationsWorking knowledge of clinical protocolsAbility to accommodate a flexible work schedule according to clinical trial(s) priorities, as neededAbility to work independently with minimal direction/oversight and within a team structureAbility to independently problem-solve or propose innovative solutionsSuperior listening and communication skillsExperienced with leading small group meetings and/or managing vendor relationshipsPositive and “can do” approachProficient in the use of Microsoft Office, advanced skills in Excel highly desirableSalary is commensurate with experienceKiniksa Benefits Summary - USAKiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment
Please contact us to request accommodation.
Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote.Responsibilities (including, but not limited to):Manage study-related vendors and serving as a point of contact for contracted CROs, study staff and contract labs; identifying potential risks and proactively resolving issues with CROs; establishing vendor management plans and reviewing quality metricsReview monitoring reports, protocol deviations and data listings for studiesCoordinate cross-functional project-related activities (e.g., Clinical Data Review meetings)Coordinate with CROs on site selection, IRB submissions, site initiation and close-out planningLead the development of reports for communicating study progress and key metrics to Senior Management and program teamPerform initial review of invoices against contracted services Assist with budget managementPrepare and provide input to study timelinesDevelop and manage study trackers and provide metrics as neededPerform and/or oversee site monitoring visits for clinical trials as neededEnsure inspection readiness and provide support to sites to prepare for clinical audits/inspectionsEnsure documentation is completed in accordance with GCP regulatory requirements and is consistent with the study protocolsOrganize and prepare study files related to study tracking and reporting and submit to the Trial Master File within established guidelinesQualifications: Requires a Bachelor’s degree with at least 3 years of relevant work experience in a pharmaceutical, academic or CRO environmentWorking knowledge of ICH/GCP regulationsWorking knowledge of clinical protocolsAbility to accommodate a flexible work schedule according to clinical trial(s) priorities, as neededAbility to work independently with minimal direction/oversight and within a team structureAbility to independently problem-solve or propose innovative solutionsSuperior listening and communication skillsExperienced with leading small group meetings and/or managing vendor relationshipsPositive and “can do” approachProficient in the use of Microsoft Office, advanced skills in Excel highly desirableSalary is commensurate with experienceKiniksa Benefits Summary - USAKiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment
Please contact us to request accommodation.
