Clinical Research Associate 2/3 - Southeast - Cystic Fibrosis

PRA Health Sciences - Remote

Full-time
Job Locations (All) | US-Remote
Posted Date 1 week ago(9/9/2019 1:56 PM)
ID
2019-57620
Overview
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.

Responsibilities
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
Qualifications
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

Skills:
Read, write and speak fluent English; fluent in host country language required.
2+ 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

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