Clinical Research Associate III

Overview

Located on the edge of the beautiful Wasatch Mountains, Sera, Inc. is a women's health diagnostics company dedicated to improving the health of babies and mothers. We are a growing company tasked with becoming a global leader in high value women's health diagnostics, delivering pivotal information that will improve health and improve the economics of healthcare delivery. According to Sera's CEO, employees and affiliates here must possess three qualities to be successful: 1) the individual must be passionate and dedicated to changing the world; 2) they must be smart and work smart; and 3) they must have absolute integrity. If this is you, we urge you to keep reading!

We are seeking a Clinical Research Associate III to support our growing company. As the CRA III, you will assist with oversight of clinical trials to ensure the quality and integrity of data and safety of participants. In coordination with Clinical Operations Leadership and study teams, the CRA III will exercise responsibility for clinical project activities related to monitoring functions and interfaces with the internal clinical research team and external clinical investigators and study site personnel in order to carry out this responsibility.

Location

Remote, limited to the following states: AZ, CA, CO, FL, ME, NC, NY, TX, UT & WA.

Responsibilities

• Contributes to the development of study materials
• Conducts pre-qualification, site initiation, interim, and study close out visits as assigned
• Monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH guidelines
• Provides regular clinical status information to team members and project management
• Ensure the site's compliance with ICH/GCP, HIPAA, and protocol specific guidelines to ensure subject safety and study compliance
• Confirm all subjects' source documents are completed and maintained appropriately
• Perform source data verification per study-specific Study Monitoring Plan
• Issue, manage, and close out data queries
• Communicate and document issues identified during monitoring visits to study personnel and establish expectations and timelines for resolution
• Complete study specific Monitoring Reports and Follow Up letters within the timeframe established in the Monitoring Guidelines
• Responds to requests from investigative sites in a timely fashion
• Escalate issues to the Study Project Manager and/or Director of Clinical Operations as necessary
• Mentors junior level CRAs and serves as a resource for new employees
• Willingness to travel up to 20% as required for site qualification visits, conferences, and investigator meetings
  
  

Required Qualifications

• Must have Bachelor's degree in Life Sciences, Nursing, or other health-related discipline
• Must have a minimum of 7 years related experience in the health care, biotechnology or diagnostics industry
• Industry experience as a CRA with a minimum of 3 years of monitoring experience required
• Must have experience writing study protocols, developing Informed Consent Forms, case report forms, and study materials
• Current knowledge of FDA regulations, ICH GCP, and local regulations
• Experience using computerized information systems, electronic data capture, and Microsoft Office Suite
• Demonstrated ability to work independently, efficiently and effectively during remote monitoring visits, training and site management
• Demonstrated interpersonal skills; ability to work as an effective team member
• Demonstrated verbal and written communication skills in English, including report writing
• Well-organized and demonstrated attention to detail
• Ability to work independently with minimal direction in a relaxed, but fast-paced, small team environment while handling multiple tasks to meet deadlines in a dynamic environment
  
  

Preferred Experience

• Clinical Research Associate Certification (CCRA)
• Experience in Maternal Fetal Medicine or Obstetrics/Gynecology
• Junior CRA mentoring/management experience
• Familiarity with Microsoft Project
  
  

Benefits for Full-Time Employees

• Dependent on experience and qualifications, the salary range for this role is $110,000 - $120,000 with an excellent benefits package featuring an 85% to 95% premium paid healthcare plan, 14 paid holidays, three weeks of paid time off, employee stock options, and more!