The In House Clinical Research Associate (IHCRA) performs investigative site recruitment/feasibility, essential document collection and review, clinical status tracking, and 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. At the Senior level, the IHCRA will manage and lead all activities listed above and will ensure that all activities meet Sponsor and PRA expectations and are delivered in accordance with the contract, trial protocol, ICH/GCP and applicable SOPs.
Demonstrates good working knowledge of PRA systems and work environment
Demonstrates thorough knowledge of clinical research industry standards, practices, and regulations.
Exhibits good decision making skills utilizing all available resources for determining positive outcomes.
Successfully interacts with both internal and external customers, representing the organization on specific projects.
In addition to above:
Minimum of 2 years of related experience
Experience with PC-Windows, word processing, and electronic spreadsheets required.
Knowledge of ICH and local regulatory authority drug research and development regulations required.
Clinical trials support or pharmaceutical industry experience required.
Same as above
Experience leading a team in a clinical research environment preferred.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.