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.
In addition to the above:
Liaises with internal and external customers to meet project specific goals including participation in sponsor and project related meetings
Acts as a liaison with clinical supply/service vendors and other functional area team members to meet project team goals.
Identifies, monitors, documents, and tracks out-of-scope activities.
Supports Clinical Team Manager (CTM)/Start Up Lead (SUL) and Clinical Research Associate (CRA) in the management of investigational sites to ensure compliance with study timelines, the trial protocol, ICH/GCP and applicable regulations.
Assists with Investigational Product accountability, subject screening/enrollment, Case Report form retrieval and query distribution to/from investigational sites.
Proficient in the development and review of Informed Consent Form templates.
May serve as an Independent Essential Document Reviewer and/or perform second review of Essential Documents .
Assists in the creation and maintenance of clinical project documents including, but not limited to Clinical Management Plans, monitoring Guidelines, Site Operations Manuals, Monitoring Visit Letter templates and Project Start-up Plans under the guidance of the SUL/CTM.
Supports the CTM/SUL/CRA to resolve internal and external clinical issues for client research projects managed by PRA.
Interacts with site, clients, vendors and PRA functional areas as secondary project contact for site issues and questions.
Supports CTM/SUL/CRA in the management of clinical budget and evaluation of study processes.
Evaluates metric data to identify process improvements.
Assists with managing and training staff.
Manages time and project requirements based on study contract.
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.
Experience with CONEP, coordinator/remaining ECs in Brazil
Experience with start-up process in other Latin America is desired
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.