Sr. Clinical Research Associate

About Servier

Servier in the U.S. is a Boston-based, commercial-stage biopharmaceutical company launched by Servier Group in 2018. As a privately held organization, Servier is uniquely positioned to advance cutting-edge science, tackle underserved therapeutic areas, and make patients the focus of every strategic decision. 

Role Summary

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.

Primary 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

1. Participate in the development of the sites recruitment plan and closely monitor the progress of recruitment of site(s)
2. 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

1. Check the validity and consistency of the data collected in the e-CRF; manage correction requests if necessary and supervise corrections
2. Identify and manage deviations with the personnel concerned at the site(s)
3. 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; 4. Manage the logistics of the investigative site(s) including investigational products, clinical materials and biological samples
4. 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

Other duties as part of the Clinical Operations team and leading CRA for a team

• 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

Education and Required 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

Travel and Location

• Remote position
• Travel up to 60% of the time

Servier’s Commitment

Servier is committed to modeling diversity, equity, and inclusion within the industry. We are dedicated to fostering an environment that maintains equitable treatment for all and we welcome applicants who are passionate, committed, and innovative individuals. We encourage candidates to apply to our open roles as we are always willing to consider experiences and skills beyond what is listed in the job description.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Salary Range

The salary range for this role is $131,000-$150,000. An employee’s pay position within the salary range will be based on several factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, performance, and business or organizational needs. We may ultimately pay more or less than the posted range, and the range may be modified in the future. Employees in this position are also eligible for Short-Term and Long-Term incentive programs. Servier also offers a competitive and comprehensive benefits package that includes benefits such as 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 among other great benefits (all benefits are subject to eligibility requirements).