Clinical Study Coordinator NEEDED!

To assist the Lead Clinical Study Coordinator with the on-site day-to-day responsibilities of the clinical protocol.
Requirements:
•Comprehensive, in-depth understanding of scientific research processes and study coordination
•Study coordination experience•Directly report to the Clinical Lead Study coordinator
•Organization and coordination of set up of study staff offices (in beginning of study)
•Organization and coordination of set up of all study-related equipment. (study supplies, etc.)
•Assist Senior Program Manager in the collection of regulatory documents (1572s, CVs, medical licenses, etc.)
•Directly enter subject information into the source documents and maintain accurate case files for each subject (maintenance of subject source documents)
•Transcribe data from source documents into the Case Report Forms (CRFs)
•Perform study site tracking for the internal database, ARD cases, enrollment/visit days, CRA visits, etc.)
•Act as shipment coordinator for serum blood samples (Inventory control, packing, storage)
•Perform inventory and accountability for study drug
•Administer study drug on vaccination day
•Administer informed consent•Perform blood draws as needed
•Assist Lead coordinator with staff training as necessary
•Perform ARD surveillance in different locations of the military base•Identify and address enrollment and site management issues as required and work with the Lead coordinator on reconciling the issues
•Appropriate documentation, processing, review, and tracking of Serious Adverse Event reports
•As required, support the Lead Study Coordinator to insure successful completion of the study•BA/BS in a scientific discipline,
Registered Nurse,•CCRC (Certified Clinical Research Coordinator) preferred
•Minimum of 1 years clinical research experience
•Must be a permanent US resident
•Thorough familiarity with GCPs and Code of Federal Regulations
•Possess excellent time management, organizational, and assessment skills
•Computer literacy (MS Office)
•Competent in Phlebotomy
•Effective verbal and written communication skills
•Ability to communicate effectively with physicians, nurses, study coordinators, CRAs, data management personnel, and vendors
Responsible for ensuring that this clinical program is conducted accordingly.Position Reports to the Lead Study coordinator of the study.