IDRx
Clinical Trial Associate
IDRx, Cambridge, Massachusetts, us, 02140
IDRX is a clinical-stage biopharmaceutical company dedicated to transforming cancer care with intelligently designed precision therapies. IDRX aims to address the limitations of today's precision cancer medicines with highly potent and selective targeted therapies to stop key tumor escape mechanisms and prolong response to therapy. IDRX's lead program is IDRX-42, designed to inhibit key genetic drivers and drug-resistant mutations of KIT in gastrointestinal stromal tumor (GIST). Founded in 2021, IDRX's leadership team has extensive experience in drug development and collectively has been involved in the discovery, development, and commercialization of more than 10 approved drugs.
About the
role:
This is a multi-faceted position with exposure to all aspects of running a clinical trial. There will be an opportunity for continual interactions with other functional departments and external vendors. The CTA will work in a dynamic environment with the opportunity to learn the day-to-day activities required to coordinate and manage a clinical trial. The CTA will work with Global Clinical Project Manager and Clinical Trial Manager to assure the time-sensitive and successful operation of a clinical study. There is opportunity for growth and to assume new responsibilities commensurate with the individual's abilities.
The broader IDRx team works primarily remotely and meets in-person in Cambridge, MA once monthly. Opportunities for more frequent in-person collaboration and engagement are possible and are driven by individual interest and availability.Responsibilities:
Administer, maintain, and coordinate the logistical aspects of clinical trials and participate in a variety of clinical activities to support and facilitate the efficient conduct of IDRx's clinical research programsAdhere to intended timelines and achievement of study goals while ensuring quality in accordance with FDA, EMA, GCP, and ICH guidelinesAssist in the coordination and tracking of clinical supply shipments, equipment, and study-specific laboratory samplesAssist the Clinical Trial Manager (CTM) and Global Clinical Project Manager in preparing Protocols, Informed Consent Forms, Investigator Brochures and other study documents, and track revisions and versioningSupport the CTMs in the set up and maintenance of study electronic filing systems (eTMF) compliant with regulations and in audit ready state, as well as general study filingEnsure that tracking tools are developed and maintained throughout the trials for the Clinical Operations teamsDay-to-day contact with counterpart at CRO; daily review and identification of potential issues or problems with the sites and communicate/escalate to CTM or senior Clinical Operations staffProvide oversight of activities related to safety reporting complianceReview and maintain SOP and study-level training documentationReview study-specific essential regulatory document packets prior to site activationsPost, update, and maintain information on clinicaltrials.gov registry(ies) and other registries as appropriateAct as Functional TMF Document Specialist for Clinical Operations, to include submission of documents to and maintenance of the Trial Master File (TMF); review TMF documents as part of the Quality Review ProcessAct as primary liaison with the CRO to collect trial documents and coordinate review of the electronic TMF to ensure inspection readiness at all timesManage insurance certificate requirementsObtain and disseminate schedules and calendars; prepare and distribute agenda and minutes for project team meetings and client meetings, and assist with tracking of action itemsRequirements:Bachelor's degree in scientific, biological, life sciences, or related field and 1+ year experience in relevant field (e.g.clinical site, CRO, sponsor or clinical trial vendor).Familiarity with ICG, GCP, and FDA requirements, as applicable, for clinical trial management.Strong skills in collaboration, communication, organization, attention to detail and multi-tasking.Sound analytical and problem-solving skills; ability to act with a consistent sense of urgency.Ability to work effectively in a fast-paced, cross-functional environment and demonstrate ability to manage changing timelines and priorities.Proficiency with Microsoft Office (Excel, Word, Outlook, PowerPoint, SharePoint).Previous experience working in oncology.
About the
role:
This is a multi-faceted position with exposure to all aspects of running a clinical trial. There will be an opportunity for continual interactions with other functional departments and external vendors. The CTA will work in a dynamic environment with the opportunity to learn the day-to-day activities required to coordinate and manage a clinical trial. The CTA will work with Global Clinical Project Manager and Clinical Trial Manager to assure the time-sensitive and successful operation of a clinical study. There is opportunity for growth and to assume new responsibilities commensurate with the individual's abilities.
The broader IDRx team works primarily remotely and meets in-person in Cambridge, MA once monthly. Opportunities for more frequent in-person collaboration and engagement are possible and are driven by individual interest and availability.Responsibilities:
Administer, maintain, and coordinate the logistical aspects of clinical trials and participate in a variety of clinical activities to support and facilitate the efficient conduct of IDRx's clinical research programsAdhere to intended timelines and achievement of study goals while ensuring quality in accordance with FDA, EMA, GCP, and ICH guidelinesAssist in the coordination and tracking of clinical supply shipments, equipment, and study-specific laboratory samplesAssist the Clinical Trial Manager (CTM) and Global Clinical Project Manager in preparing Protocols, Informed Consent Forms, Investigator Brochures and other study documents, and track revisions and versioningSupport the CTMs in the set up and maintenance of study electronic filing systems (eTMF) compliant with regulations and in audit ready state, as well as general study filingEnsure that tracking tools are developed and maintained throughout the trials for the Clinical Operations teamsDay-to-day contact with counterpart at CRO; daily review and identification of potential issues or problems with the sites and communicate/escalate to CTM or senior Clinical Operations staffProvide oversight of activities related to safety reporting complianceReview and maintain SOP and study-level training documentationReview study-specific essential regulatory document packets prior to site activationsPost, update, and maintain information on clinicaltrials.gov registry(ies) and other registries as appropriateAct as Functional TMF Document Specialist for Clinical Operations, to include submission of documents to and maintenance of the Trial Master File (TMF); review TMF documents as part of the Quality Review ProcessAct as primary liaison with the CRO to collect trial documents and coordinate review of the electronic TMF to ensure inspection readiness at all timesManage insurance certificate requirementsObtain and disseminate schedules and calendars; prepare and distribute agenda and minutes for project team meetings and client meetings, and assist with tracking of action itemsRequirements:Bachelor's degree in scientific, biological, life sciences, or related field and 1+ year experience in relevant field (e.g.clinical site, CRO, sponsor or clinical trial vendor).Familiarity with ICG, GCP, and FDA requirements, as applicable, for clinical trial management.Strong skills in collaboration, communication, organization, attention to detail and multi-tasking.Sound analytical and problem-solving skills; ability to act with a consistent sense of urgency.Ability to work effectively in a fast-paced, cross-functional environment and demonstrate ability to manage changing timelines and priorities.Proficiency with Microsoft Office (Excel, Word, Outlook, PowerPoint, SharePoint).Previous experience working in oncology.