[Remote] Assistant Clinical Research Manager - Breast Oncology Clinical Trials

Note: The job is a remote job and is open to candidates in USA. Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. The Assistant Clinical Research Manager position will assist in managing the Breast Oncology clinical research program, ensuring compliance with regulatory standards and overseeing clinical trial operations.ResponsibilitiesAssistant Clinical Research Managers (ACRM) will be responsible for assisting the Clinical Research Manager with the oversight of their disease group’s clinical trial portfolio and all related regulatory and compliance requirementsThe ACRM will assist the CRM will all aspects of study start up, active and close out activities for the group’s portfolio. They will be responsible for the required tracking of all protocol development, submission, review and approval milestonesThe ACRM will assist with the oversight of subject enrollment, protocol treatment and follow-up care processes for protocol patientsAssist with the oversight of registration of protocol patients, study group registrar and pharmaceutical company as outlined in protocolAssists in the responsibility for essential document compliance for entire portfolio. Implements systems to monitor and ensure regulatory document collection and maintenance complianceAssists in the responsibilities for all clinical trial reporting requirements; safety event, annual approval, deviations etc. May implement systems to monitor portfolio complianceAssists the study team to be maintain an “audit ready” research environmentAssists CRM with responsibility for data management and compliance for entire portfolio. Maintains schedules and procedures necessary for timely and complete data collectionRegularly reports data compliance status to key stakeholders; i.e. DFCI PI, study Sponsor, DFCI CTO. Helps to implement corrective action to maintain data compliance when necessarySubmits required “progress / tracking “reports to key stakeholders, when applicableWill assist the CRM with the recruitment and oversight of coordinator staff as well as ensures that staff have completed mandatory training in a timely mannerWill help implement program specific on-boarding and orientation process and may participate in annual performance evaluations and competency assessments of research staff as neededSkillsBachelor's Degree requiredMust be able to perform day-to-day responsibilities independently with minimal supervision from managersHas the ability to identify regulatory scenarios that require consultationHas a good understanding of clinical trials start-up, active and close out phasesHas a good understanding of clinical research, local policy and federal regulationKnowledge of cancer as a disease process, cancer treatment modalities, and the clinical trial processHas experience in protocol development, data compilation and analysisThe ACRM will have a good understanding of the various tracking systems used to ensure timely data management by the clinical research staffThey will also understand Federal and State regulations as they relate to researchStrong interpersonal, organizational and communication skills are requiredMust have computer skills including the use of Microsoft OfficeMust have the ability to function independently, think critically and with good professional judgmentMinimum of 3 plus years of related experience preferredBenefitsRemote: 100% off siteCompany OverviewDana-Farber Cancer Institute is a cancer research and treatment organization that provides specialized care for cancer patients. It was founded in 1947, and is headquartered in Boston, Massachusetts, USA, with a workforce of 1001-5000 employees. Its website is http://www.dana-farber.org.Company H1B SponsorshipDana-Farber Cancer Institute has a track record of offering H1B sponsorships, with 49 in 2026, 191 in 2025, 145 in 2024, 155 in 2023, 139 in 2022, 105 in 2021, 113 in 2020. Please note that this does not guarantee sponsorship for this specific role.