Job Locations - | US-NC-Raleigh
Posted Date 1 month ago(6/20/2018 4:09 PM)
Who are we?
We Are PRA.
We are 15,000+ employees strong, operating in more than 85 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?
Whether you work at a research site, with a sponsor or at another CRO, you are known to friends and colleagues alike as the “go-to” person. You have excellent communication & follow-up skills. With your commitment to executing projects in accordance with the highest standards, you hold a certain reverence for the regulatory processes, SOPs and document trails that map out a pathway to compliance. But most of all, you are someone with tremendous potential who wants to apply your many talents in a role that will expand your fundamental knowledge of clinical research and provide you with the options and training to continue to grow in your career.
What will you be doing?
As an IHCRA, you are the primary point of contact/liaison for the sites, Sponsor and internal stakeholders during the study life cycle. You will perform investigative site recruitment/feasibility, essential document collection and review, maintenance and close-out in-house site management activities in accordance with the Sponsor and/or PRA protocol, standard operating procedures (SOPs), ICH/GCP guidelines and all applicable regulatory requirements. Senior-level IHCRAs will manage all activities listed above, ensure that they meet Sponsor & PRA expectations, and deliver them in accordance with the contract, trial protocol, ICH/GCP and applicable SOPs.
What do you need to have?
Bachelors degree or, an equivalent combination of education and experience sufficient to successfully perform the key responsibilities of the job.
Experience using computerized information systems and standard application software (Windows, MS Office)
Excellent written and oral communication skills
Knowledge of ICH and local regulatory authority drug research and development regulations preferred
Clinical trials support or pharmaceutical industry experience strongly preferred
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.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans, and individuals with disabilities.
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