Clinical Research Associate
South San Francisco, California
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Comprehensive coverage including medical, dental, vision, and health and wellness programs.
Sanofi wants to ensure employees are equipped for financial health, Sanofi provides a competitive 401K Match program and Financial Wel-Being Tools and Programs.
At Sanofi, we demonstrate our commitment to inclusion and diversity through Culture groups and programs. There are many ways to make a difference and connect with other Sanofi employees: including ERG groups and 2 PAID days off to Volunteer.
Sanofi provides significant Work/Life benefits to help you excel beyond the workday. Including Workplace Flexibility through part‑time, remote work, flex‑time and job share options.
"At Sanofi, We are guided by a deep appreciation and understanding of what it means to live with a rare blood disorder, and we learn by listening to the community – patients, caregivers physicians, and other healthcare professionals."
"Patients are at the center of all that we do at Sanofi. Our teams are focused on advancing transformational therapies that can address serious unmet needs for people living with rare blood disorders, and expanding global patient access to our medicines."
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.
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.
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.