[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.

Responsibilities

• Implement 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 COPM
• Take an active role in the creation of the study monitoring plan, reference documents for sites; review other study related manuals and supportive documents if needed
• Ensure 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 letter
• Participate 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 tasks
• Perform monitoring activities according to the study specific protocol and monitoring plan
• At 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 COPM
• Check the validity and consistency of the data collected in the e-CRF; manage correction requests if necessary and supervise corrections
• Identify 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 concerned
• Manage the logistics of the investigative site(s) including investigational products, clinical materials and biological samples
• Serve 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 encountered
• Report all monitoring activities (update data in the various clinical data management systems), write visit reports and follow-up letters to investigators
• Perform site(s) closure visit
• Assist the COPM in organizing investigators meetings
• Train newcomers in the team including CRA(s), VIE, CTA
• Assist in the preparation of ISF binders
• Actively involved with regulatory submission including the site’s ICF review and validation, under COPM’s supervision
• Assist COPM for budget and contract negotiation
• Participate 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 needed
• Involve in the preparation of study(ies) audits / inspections, assist other CRA(s) in the preparation of site(s) audits/inspections
• Respond to observations from audits/inspections and ensure the implementation of the corrective and preventive actions
• At Hub level, actively involved in processes improvement and tools development
• Function as SME for CRA or CRA referent for the Americas Hub

Skills

• Bachelor's degree or equivalent education/experience preferred in Scientific/health care field
• 5+ years of Clinical Operations experience (including Clinical Research Associate roles) within a pharmaceutical company or CRO
• Knowledgeable of current FDA and IRBs regulatory requirements and guidelines governing clinical research
• Ability to oversee, manage and communicate effectively with clinical sites
• Strong attention to detail, establish priorities and meet deadlines
• Ability to work independently and take initiative
• Strong knowledge of applicable computer software applications
• Strong interpersonal skill set necessary to create and maintain internal and external collaborator relationships

Benefits

• Short-Term and Long-Term incentive programs
• Medical
• Dental
• Vision
• Flexible time off (Servier provides unlimited sick time and flex time, and does not accrue time off)
• 401(k)
• Life and disability insurance
• Recognition programs

Company Overview

Company H1B Sponsorship