Sr. Clinical Research Associate

SERVIER MONDE•United States, CA

3d•$131,000 - $150,000•Remote

About The Position

The Sr Clinical Research Associate (Sr CRA) ensures the effective management and monitoring of clinical studies in the site(s) assigned by the Clinical Operations Project Manager (COPM), while respecting the protocol and in accordance with the standards of local regulatory authorities, the rules of Good Clinical Practice (ICH / GCP) and Servier Standard Operating Procedures (SOPs). This position could act as the leading CRA for the CRA team, and will assist COPM in all projects set up and management aspects and require a proven record of hands-on experience in processes such as study feasibility and site qualification, TMF and ISF set up, creation of monitoring plans and preparation of IRB submission packages among other duties.

Requirements

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

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