Senior Lead, Clinical Study Coordinator w/ Military Experience

To oversee the on-site day-to-day management of a clinical protocol as well as managing the following study personnel: Clinical research study coordinators, Clinical Research Associates, Clinical Program Assistants, and Laboratory Techs / Phlebotomists.

•Provide oversight and management for up to 10 full-time and between 80-100 part-time staff
•Organize and manage a daily schedule for each staff member
•Assist Senior Program Manager in training study staff
•Maintain accurate tracking record of work completed by ALL study staff
•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.)
•Supervise the collection of field data (source document review & transcription to CRFs)
•Supervise maintenance of an accurate case file for each subject (maintenance of subject source documents)
•Identify and address enrollment and site management issues as required
•Ensure timely processing, review, and tracking of Serious Adverse Event reports
•As required, support the Principal Investigator to ensure successful completion of the study
•As required, assist the Senior Program Manager to ensure successful completion of the study
•Responsible for ensuring that this clinical program is conducted according to SOPs and GCPs.
•Directly report to Principal Investigator (PI); administratively report to Senior Program Manager

We are looking for someone with previous Military Experience, or coming from a Military background.Education Required:
•BA/BS in a scientific discipline, Registered Nurse, or Military experience equivalent to a Navy Corpsman/Airforce Medical Service Specialist/Medical Technician
•CCRC (Certified Clinical Research Coordinator) preferred


•Minimum of 3 years Clinical Research experience - comprehensive, in-depth understanding of scientific research processes and study coordination – MANDATORY
•Significant Military background – MANDATORY
•Experience having worked at Fort Jackson Army Center – STRONG PREFERENCE, but not Required
•Thorough familiarity with Good Clinical Practices (GCPs) and Code of Federal Regulations (CFR)
•Ability to model forecasts of clinical study conduct & performance versus actual results
•Ability to communicate effectively with physicians, nurses, study coordinators, CRAs, data management personnel, and vendors
•Competent in Phlebotomy
•Project and staff coordination experience
•Ability to anticipate staffing needs
•Ability to organize and manage a staffing schedule
•Capable of resolving enrollment and logistical problems as necessary
•Computer literacy with MS Office products (Word, Excel, PowerPoint)
•Strong leadership skills
•Effective verbal and written communication skills
•Possess excellent time management, organizational, and assessment skills
•Must be a permanent US resident or US Citizen
Must be cleared by military personell.

Keywords:
Full Time, Pharmaceutical, Management, Health care, Project Management, Chemical, Research, Development, Trial, Clinical Study Coordinator