[Remote] Senior Clinical Research Associate-Contractor

Note: The job is a remote job and is open to candidates in USA. SystImmune is a leading clinical-stage biopharmaceutical company specializing in innovative cancer therapies. They are seeking an experienced Senior Clinical Research Associate Contractor to support the execution and oversight of clinical trials, ensuring patient safety, protocol compliance, and data integrity.ResponsibilitiesConduct Site Qualification Visits (SQVs), Site Initiation Visits (SIVs), Interim Monitoring Visits (IMVs), and Close-Out Visits (COVs)Support site management activities to ensure compliance with protocol requirements, GCP, applicable regulations, and study timelinesCollaborate with CROs, central laboratories, specialty vendors, and internal stakeholders to support study execution and site readinessVerify that investigator sites have completed all regulatory, contractual, and operational requirements prior to site activation and study drug releaseAssist with development and review of study-related documents, including Monitoring Plans, eCRF Completion Guidelines, Data Management Plans, and Safety Management PlansMonitor site enrollment activities and proactively identify and escalate recruitment challenges and mitigation strategiesPerform remote and on-site monitoring to assess patient safety, protocol compliance, source data verification, and data qualityPartner with site personnel to ensure timely and accurate data entry and prompt resolution of data queriesMaintain study documentation and ensure completeness of site regulatory files and essential documentsIdentify, document, and follow up on Serious Adverse Events (SAEs) in accordance with study and regulatory requirementsSupport database lock activities, data review, patient profile review, and site closeout activities as neededEnsure timely submission and maintenance of essential documents within the Trial Master File (TMF/eTMF)Review investigational product accountability, storage conditions, reconciliation activities, and protocol compliance related to investigational product managementEscalate site issues, risks, and compliance concerns to study leadership in a timely mannerSkillsBachelor's degree in Life Sciences, Health Sciences, Nursing, or a related fieldMinimum of 5 years of independent oncology monitoring experience in industry-sponsored clinical trialsDemonstrated experience conducting both on-site and remote monitoring visitsStrong knowledge of ICH-GCP, FDA regulations, and clinical trial conduct requirementsExperience working with CTMS, EDC, eTMF, and other clinical trial management systemsProven ability to build productive relationships with investigators and site personnelExcellent written, verbal, organizational, and time management skillsAbility to manage multiple priorities in a fast-paced clinical development environmentAbility to travel approximately 50–75% as requiredExperience supporting early-phase oncology studies is highly preferredCompany OverviewSystImmune is a biotechnology company. It was founded in 2014, and is headquartered in Redmond, Washington, USA, with a workforce of 51-200 employees. Its website is https://www.systimmune.com.Company H1B SponsorshipSystImmune has a track record of offering H1B sponsorships, with 2 in 2026, 14 in 2025, 1 in 2023, 2 in 2022, 2 in 2021, 1 in 2020. Please note that this does not guarantee sponsorship for this specific role.