Lead Clinical Research Associate 3 - Vaccines - Home Based - East Coast at Pharmaceutical Research Associates, Inc. in Raleigh, North Carolina

Posted in Health Care 5 days ago.

Job Description:

Pharmaceutical Research Associates, Inc.

Lead Clinical Research Associate 3 - Vaccines - Home Based - East Coast


Job ID: 2021-73605
Type: US-Northeast
# of Openings: 1
Category: Clinical Monitoring

Sanofi Pasteur


Do you want to watch clinical development change, or do you want to be the one to shape it?

Because we’re hoping you’re here for the latter.

Who are we?

We Are PRA.

We are 16,000+ employees strong, operating in more than 90+ countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We help get life-saving drugs into the hands of those who need them most.

Who are you?

You are a forward thinker. You are an innovator that refuses to settle. You want to push the boundaries and change not just what it means to be a Clinical Research Associate, you want to change the future. You want to learn from the best, grow your knowledge and your skill set, and you want to build your career here. You want to use the latest technology and tools in the industry to push the momentum of an already growing company forward. You want to find a balance that still lets you be, well, you. Most of all, you want to do it in a place where you’re more than an employee number. A place you love working.

Still here? Good. Because if this is you, we’d really like to meet you.


  • What will you be doing?

    As a Clinical Research Associate, you will monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.

    • Applies knowledge of PRA’s policies and procedures
    • Demonstrates excellent written and oral communication
    • Demonstrates excellent knowledge of ICH/GCP
    • Displays ability to manage investigative sites to facilitate trial deliverables
    • Demonstrates ability to escalate issues appropriately
    • Conducts monitoring to confirm subject safety and data ntegrity
    • Describes and demonstrates the principals of IP accountability
    • Identifies scientific misconduct at the site level
    • Demonstrates working knowledge of Microsoft Office applications, Clinical Trial Management Systems, IVRS/IWRS and Electronic Data Capture platforms
    • Mentors CRAs new to the position or company
    • Serves as an observation visit leader
    • Conducts monitoring evaluation visits
    • Assists team lead in the development of trial tools or documents


  • What do you need to have?

    Education: Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required


    • Read, write and speak fluent English; fluent in host country language required.
    • 5 years of clinical monitoring experience required
    • Knowledge of ICH and local regulatory authority regulations regarding drug
    • Clinical research experience
    • Knowledge of ICH and local regulatory authority regulations regarding drug
    • An advanced degree (e.g., M.S., M.B.A., PharmD, etc)
    • Experience in monitoring all trial components (PSSV to COV)
    • Experience in coaching/mentoring other CRAs

    PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

    To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status