• Understands and adheres to Good Clinical Practice (GCP), U.S. Food and Drug Administration (FDA), and Institutional Review Boards (IRB) guidelines

• Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures

• Assist with periodic review of study files for completeness

• Assist CRCs with preparation, handling, and distribution of Clinical Trials Supplies and maintenance of tracking information

• Assist with the tracking and management of Case Report Forms (CRFs), queries, and clinical data flow

• Act as a central contact for the clinical team for designated project communications, correspondence, and associated documentation

• May accompany CRCs to assist with clinical monitoring duties upon completion of required training

• Maintains security and confidentiality of patients and study-specific information per protocols and applicable federal regulations

• Performs other required duties as requested by the Clinical Research Lead, Director, or Principal Investigator

Education/Experience/Certifications

• High School Graduate or equivalent required

• College Graduate preferred

• Current Good Clinical Practice certification required (must be obtained in the first 14 days after hire)

Technical Skills:

• Intermediate computer skills: Microsoft Word, Outlook and Excel preferred

• Intermediate clerical skills: typing, data entry, filing, and record keeping