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 basic knowledge of the office environment and related systems.
* Demonstrates limited knowledge of clinical research industry practices and standards.
* Exhibits good communication and interpersonal skills.
* 0 - 2 years of related experience
* Prior experience using computerized information systems.
* Read, write, and speak fluent English; fluent in host country language required
* Undergraduate degree or its international equivalent in clinical, science, or health related field from an accredited institution or a licensed healthcare professional
* Clinical trials support or pharmaceutical industry experience preferred.
* Experience with PC-Windows, word processing, and electronic spreadsheets preferred.
* Office based or clinical employment experience preferred.
* Knowledge of ICH and local regulatory authority drug research and development regulations preferred.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
Associated topics: clinical, clinical development, clinical informatics, clinical trial, coordinator, lab, laboratory, research, research coordinator