Find Careers in Engineering, Finance, IT, Science & More with Kelly Services | Job Description

Sr Clinical Research Associate (CRA)

Sr Clinical Research Associate (CRA) contract to hire



The Sr Clinical Research Associate (CRA) will perform and coordinate key aspects during the conduct and monitoring of clinical trials in accordance with GCP/ICH Guidelines and SOPs.  This includes project planning, budget, and contract Clinical Research Organizations (CRO) management. This position will work closely with the other members of the Clinical Development Team (including Medical Monitor, Project Management , Clinical Pharmacology, Regulatory, Legal, Finance and QA) and will also interact with CROs, Investigator sites, central laboratory vendors and other external vendors.  



  • Participate in all aspects of clinical trials including study start-up activities through close-out. 
  • Develop and track overall study budget. 
  • Provide project planning updates to ensure adherence to timelines
  • Communicate regularly with clinical investigative site personnel, (including study nurses, coordinators, and physicians), contract research organizations (CROs) and internal key personnel to ensure clinical project goals are achieved within the team goals and according to SOPs. 
  • Visit clinical sites and CROs whenever needed.
  • Review and approve CRA staff assignments proposed by CROs.
  • Ensure compliance with protocol and project guidelines as well as GCP/ICH Guidelines, consistency w/ Sponsor and CRO SOPs.
  • Responsible for participating in program specific weekly teleconferences with CROs.  Escalate project issues to the attention of the Clinical Operations Director as well as the Medical Monitor/Project Physician in a timely fashion.
  • Track the day-to-day progress of clinical site activities and updates the appropriate.
  • Participate in editing and review of clinical study protocols and investigator brochures as needed.    
  • Review regulatory documents and/or regulatory checklists to ensure completeness prior to study site initiation and study drug delivery. 
  • Regular review of monitoring reports, EDC screens, data queries, data query resolutions to ensure protocol compliance. Perform ongoing data review to ensure safety and high quality data collection, for accuracy and completeness.
  • Review qualifications of investigators and site staff and make recommendations for their participation in a clinical study.  
  • Review of Trial Master Files prior to archiving.
  • Coordinate the shipment of study supplies to trial sites as needed. 
  • Work with Clinical Ops team to manage vendor and site budgets



  • Support various needs required by regulatory applications and submissions.
  • Update SOPs for Clinical Operations when required
  • Participate in editing and review of documents such as clinical study protocols, clinical study reports, investigator brochures and documents required in regulatory submissions as needed.    
  • Contribute to verifying accurate navigation of hyperlinks within the eCTD format to insure submission readiness.
  • Other tasks or projects as assigned based upon company needs.




  • Undergraduate degree or RN/BS Degree in Biological Sciences, Biomedical Sciences or related field.
  • Must have knowledge of Good Clinical Practices (GCP) and FDA Guidelines and Regulations


Job Experience:

  • 7+ years of Clinical Research experience for Senior level role
  • Prior experience managing CROs and vendors.
  • Proficient report writing (e.g., meeting minutes, monitoring reports, evaluation reports, letters to sites or vendors) and verbal reporting



  • Strong computer skills (Word, Excel, PowerPoint)
  • Must be able to work independently and as part of a team with high degree of professionalism
  • Ability to effectively and professionally communicate (written and verbal) at all levels 
  • Must have keen sense of urgency and time management skills to convey critical issues to supervisor and/or Clinical Development Team


Working Conditions:

  • Some work is performed in a typical office work environment and some work in a clinical environment
  • Occasional travel required

Why Kelly®?

Kelly® Science is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

Kelly complies with the requirements of the Fair Chance Initiative. A conviction record does not automatically bar individuals from employment.

Related jobs you might be interested in...
Small Animal Research Tech...
Coon Rapids MN
Full Time
Environmental Monitoring T...
Santa Ana CA
Full Time
Food Microbiologist - Cars...
Carson CA
Full Time
One moment please...

Create an Account or sign in using one of your social networks by clicking an icon below. You can also Create an Account by uploading your resume

As of Sep 19, 2019 our security requirements for account passwords have been updated and you are required to click the Forgot Password link to create a new password.
Forgot Password        
Verify Email
First Name
Last Name
Verify Password


Choose your resume:
You currently don't have any resumes uploaded. Please upload one to continue.
Resume Title
Upload a Resume
Candidate Experience Site Guest User
Time Zone:
EST (Eastern Standard)
Area(s) of expertise:
Communication Preference:
Thank you for your interest in this job.
Your resume has been successfully submitted.

What would you like to do next?

One moment please...