Clinical Project Lead - Paidion (Remote U.S. and Canada only)

Paidion Research, Inc., a global pediatric clinical research organization, is part of Camargo Pharmaceutical Services. Together, we're impacting healthcare for children through end-to-end pediatric drug development solutions to reach more patients faster.

We are seeking a candidate that can perform operational oversight of assigned clinical operations activities for an investigational trial.  Manage investigative sites according to the Federal Code of Regulations, Good Clinical Practices, ICH Guidelines, local regulations, and SOPs and/or customer SOPs.   Collect, document, update, and report study information according to procedures and timelines. Create new and customize existing templates and processes to meet project needs proactively and with some direction. Follow up, resolve, and report on issues identified  in a proactive manner.   Manage Site Monitors assigned to the trial including review of trip reports, performing quality assessment visits, as well as being assigned sites to monitor and manage.  Prepare metrics and reports regarding monitor performance as requested by the Clinical Project Manager (CPM)

Requirements for this role are:

• Bachelor's degree in nursing, pharmacy or other allied health care discipline, including appropriate certification/licensure. Master's degree or other post-graduate training in a clinical discipline is not required but a plus.
• Minimum of two (2) years' experience with strong clinical knowledge.
• Minimum of one (1) year of previous monitoring experience is required.  
• Current or prior experience at a CRO.
• Pediatric experience is preferred.
• Broad knowledge of the drug development process.
• This role requires proof of a current drivers' license.
• Knowledge of ICH guidelines and GCP, including international regulatory requirements for the conduct of clinical development programs is also a must.
• This role will require some travel.