Clinical Research Associate

POSITION SUMMARY

*** Ideal candidate would be located in South San Francisco or on the West Coast. Industry experience (Sponsor Company) strongly preferred. ***

Sanofi is seeking an experienced Clinical Research Associate who will provide support to the Clinical Operations team in the management and execution of a clinical research study or multiple clinical studies. 

ESSENTIAL FUNCTIONS

• Work collaboratively with the clinical operations group and cross functional team to ensure successful implementation of clinical trials

• Liaise with the Contract Research Organization (CRO) and other third-party vendors to ensure quality deliverables are completed within established timelines

• Develop study plans with the CRO and ancillary vendors to ensure study requirements and adherence to plans are achieved

• Participate in site qualification, initiation, interim monitoring, and close-out visits as needed; Ensure monitoring is performed in accordance with the monitoring plan and ICH GCP - Good Clinical Practice ICH E6(R2) and applicable SOPs and regulations

• Perform sponsor oversight activities of CRO clinical monitoring activities including review of reports, protocol deviations, KPIs, etc

• Assist in creation and review of Informed Consent Form templates, provide input to clinical sections of protocol, IB and other trial related documents

• Develop and maintain study tools and enrollment/status trackers for clinical studies

• Help in facilitation and coordination of internal and external meetings with vendors and investigators

• Prepare internal meeting minutes and compile metrics to study team

• Attend/participate in the preparation and presentation at investigator meetings

• Assist in creation of newsletters and correspondence to sites and vendors.

• Review site regulatory documentation for investigator drug product release and site activation

• Conduct periodic review and QC of the trial master file; oversee management of TMF is in accordance with the TMF plan

• Provide necessary updates on site information for clinical trial disclosure

EDUCATION / EXPERIENCE, KNOWLEDGE, SKILLS REQUIRED

• BA or BS preferably in sciences

• 2-4 years of pharmaceutical industry experience, in either biotech or CRO

• Oncology therapeutic experience and clinical monitoring or clinical study management is required

• Knowledge of Good Clinical Practices

• Proven clinical trial management skills and study leadership ability

• Ability to coordinate and collaborate across teams and to work across a variety of projects and tasks

• Excellent interpersonal, written, and verbal communication skills

• Strong organizational/analytical and computer skills

• Experience with EDC, IRT database platforms and clinical trial management systems

• Ability to travel up to 20%

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

The salary range for this position is $68,145.00 - 90,860.00 to $113,575.00. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the link, www.benefits.sanofiusallwell.com

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.