This position assists in the coordination of clinical research projects starting with the evaluation of feasibility and safety of the study. The position will participate actively in the research projects of a diverse group of researchers in the EVMS community.  We partner with NIH, CDC, independent  granting agencies, pharmaceutical and device companies to gain funding and support for clinical research.  This position provides support for ongoing reporting, recruitment and retention of study subjects.  T

he position involves consenting subjects, collecting data, entering data, performing clinical testing, collection of specimens, processing of specimens, preparing specimens for shipment to laboratory facilities. The position involves collaborating with other faculty, residents and medical students to execute protocols.  

This position requires adherence to FDA, GCP and ICH guidelines. Development of documents for aligning activities with the protocol requirements and verification of required activities, tests and results. Ensure that documentation is Attributable, Legible, Contemporaneous, Original, Accurate, complete, Consistent, Enduring and available.  

This position requires strong communication and organizational skills.  Maintenance of study materials and supplies to ensure they have not expired.  Maintenance of study logs and documents to support training and active staff members/PI/subI's. This position requires identification and reporting of adverse events under the guidance and direction of the clinical team. 

Key duties include:

• Training requirements for each protocol (this could include travel and attendance at a centrallized meeting or virtual learning)
• Development of documentation tools to support the collection of data for the research 
• Screening and recruitment of subjects to support the research 
• Collection of data, execution of tasks, testing and entering data 
• Maintenance of study logs, supplies and ongoing education 

Required: General keyboard, Word processing, basic excel skills.  Strong and effective communication skills. 

Preferred: College degree in health or science related field, Phlebotomy, Prior clinical research experience .