Responsible for monitoring clinical research sites in accordance with FDA Regulations, GCP compliance and company SOPs. Provide guidance to clinical sites including training on completion of case report forms. Monitor patient study data for completion, accuracy and compliance with clinical protocol.
- Conduct patient data monitoring for accuracy and protocol compliance
- Conduct site qualification, initiation and site close-out visits and complete all appropriate documentation related to the visits.
- Up to 80% travel required during peak times
- Provide support in site recruitment Support in the compiling and analysis of patient data
- Obtaining/reviewing/processing of regulatory and administrative documents from investigative sites
- Liaise with sites to ensure sufficient study drug is available for clinical activities
- Request sites to return unused study drug and upon arrival review for shipment integrity
- Review documentation of blood samples/specimens and tumor slides submitted by sites
- Maintain inventory of clinical supplies and ship to sites as needed Other duties as assigned
Understand the job specific system and processes as defined by the company’s SOPs and adhere to the requirements listed in those documents. If any of the procedure or process requirements are unclear or ambiguous, it is the responsibility of the employee to notify his/her supervisor or manager. Maintain corporate confidentiality at all times
- BS/BA degree in a relevant field of science or at least four years relevant work experience and a demonstrated working knowledge of the principals involved in clinical research.
- This position requires proficiency in MS Office including Word and Excel.
- One must also possess excellent written/oral communication skills as well as the ability to efficiently multi-task.
- This position requires an individual to organize medical and scientific information in order to provide comprehensive support to both colleagues and participating clinical sites.