[Remote] Sr. Clinical Research Associate

Note: The job is a remote job and is open to candidates in USA. Servier Pharmaceuticals is a Boston-based biopharmaceutical company focused on advancing science and addressing therapeutic needs. The Sr Clinical Research Associate (Sr CRA) will manage and monitor clinical studies, ensuring compliance with protocols and regulatory standards, while also leading CRA teams and assisting in project management tasks.ResponsibilitiesImplement and monitor site(s) in assigned study(ies)Contribute to the site’s identification and selection process, conduct the site’s selection and qualification visits under the supervision of COPMTake an active role in the creation of the study monitoring plan, reference documents for sites; review other study related manuals and supportive documents if neededEnsure the preparation of the site before the initiation visit and carry out the initiation visit and related follow up actions including initiation visit report and follow-up letterParticipate in the development of the sites recruitment plan and closely monitor the progress of recruitment of site(s)Assist in the creation of the Investigator Site File (ISF)When applicable, lead the CRA team of a specific study to organize and carry out trainings to all site’s research teams on the study protocol and related tasksPerform monitoring activities according to the study specific protocol and monitoring planAt study level, monitor the progress of clinical trials and ensure the quality, reliability and authenticity of data collected according to protocol, Servier SOPs, regulatory requirements and GCPs of all sites with the supervision of COPMCheck the validity and consistency of the data collected in the e-CRF; manage correction requests if necessary and supervise correctionsIdentify and manage deviations with the personnel concerned at the site(s)Ensure the detection and careful monitoring of adverse events (AE) and serious adverse events (SAE) representing pharmacovigilance cases and ensure the transmission of information to the departments concernedManage the logistics of the investigative site(s) including investigational products, clinical materials and biological samplesServe as technical support to the investigators and be the first point of contact with the site’s staff regarding the monitoring and resolution of problems encounteredReport all monitoring activities (update data in the various clinical data management systems), write visit reports and follow-up letters to investigatorsPerform site(s) closure visitAssist the COPM in organizing investigators meetingsTrain newcomers in the team including CRA(s), VIE, CTAAssist in the preparation of ISF bindersActively involved with regulatory submission including the site’s ICF review and validation, under COPM’s supervisionAssist COPM for budget and contract negotiationParticipate to UAT for the systems used for assigned study(ies)Participate in Data Review along with COPM for the assigned study(ies)Collaborate actively with the other members of the project team (Medical Monitor, Clinical Medial Scientist, other CRAs, CTA, Data Management, PV, CLL, CSU and etc) when neededInvolve in the preparation of study(ies) audits / inspections, assist other CRA(s) in the preparation of site(s) audits/inspectionsRespond to observations from audits/inspections and ensure the implementation of the corrective and preventive actionsAt Hub level, actively involved in processes improvement and tools developmentFunction as SME for CRA or CRA referent for the Americas HubSkillsBachelor's degree or equivalent education/experience preferred in Scientific/health care field5+ years of Clinical Operations experience (including Clinical Research Associate roles) within a pharmaceutical company or CROKnowledgeable of current FDA and IRBs regulatory requirements and guidelines governing clinical researchAbility to oversee, manage and communicate effectively with clinical sitesStrong attention to detail, establish priorities and meet deadlinesAbility to work independently and take initiativeStrong knowledge of applicable computer software applicationsStrong interpersonal skill set necessary to create and maintain internal and external collaborator relationshipsBenefitsShort-Term and Long-Term incentive programsMedicalDentalVisionFlexible time off (Servier provides unlimited sick time and flex time, and does not accrue time off)401(k)Life and disability insuranceRecognition programsCompany OverviewServier Pharmaceuticals is a pharmaceutical company dedicated to therapeutic progress to serve patient needs. It was founded in 2018, and is headquartered in Boston, Massachusetts, USA, with a workforce of 201-500 employees. Its website is https://www.servier.us/.Company H1B SponsorshipServier Pharmaceuticals has a track record of offering H1B sponsorships, with 1 in 2026, 2 in 2025, 4 in 2024, 4 in 2023, 3 in 2022, 15 in 2021, 2 in 2020. Please note that this does not guarantee sponsorship for this specific role.