Job Title:  Executive Director – Clinical Research and Regenerative Medicine

 

Job Duties:

Perform tissue culturing on wounds or abscess to identify the microorganisms causing infection. Perform stem cell clinical research using molecular biology and cryobiology techniques for required clinical trials. Prepare study protocol for hospital (local) and Central Institutional Review Board (IRB); coordinate study with hospital directors and clinic physicians. Retrieve, create and view SOPs. Isolate cells from human tissue samples; prepare specimens for molecular analysis. Transport tissue samples to laboratories using sterile techniques and monitor regularly. Maintain accurate, detailed and up to date records regarding procedures performed and results obtained. Remain in direct contact with laboratory and microbiology department and hospital/clinic pharmacies for dispensing study drug during patient’s hospital stay. Assist physicians in the preparation of Platelet Rich Plasma (PRP) procedures in wound healing process. Provide complex scientific and technical leadership in determining research priorities, design and execution of research projects. Ensure validity of research results through timely, accurate and complete data submission, subject query resolutions and reporting of deviations. Manage day-to- day activities of clinical research team, working closely with cross functional study team, including external partners to ensure proper execution of ongoing clinical studies and initiation of new clinical trials to meet key milestones. Coordinate and participate in budgetary negotiations with industry sponsor and Investigator-Initiated studies. Accountable for financial management within areas of responsibilities.  Assist and contribute to preparation and review of clinical protocols, clinical documents, regulatory documents, CRF, medical monitoring and safety management plans, informed consent, statistical analysis plan, publications, IB, DSUR, TLFs, CSRs and relevant clinical documents for investigator-initiated and Sponsor studies. Support development of clinical trial staff, trial processes and enhancement of trial execution and organizational advancement. Participate in the development and implementation of the operational plans for each clinical project that are compliance with ICH-GCP and FDA regulations. Maintain accurate and complete records related to Institutional Review Board (IRB) communication, source documentation, CRFs, and study related communication. Coordinate all aspects of the study including recruitment, consent, screening, scheduling, tracking and providing study updates to study participants throughout the conduct of the study. Lead research staff in preparing, organize and participate in internal audits, Pharmaceutical companies  audits, monitoring visits and FDA auditing visits.  Act as the liaison between the sponsor, CRO, investigative site staff, laboratory, pharmacy, Ancillary departments, Satellite research sites and other internal and external personnel as the study requires. Ensure study team is in compliance with Study Protocol adherence, ICH-GCP, IATA, HIPAA and FDA appropriate regulations, policies and procedures from studies start up to closeout. Assist PI and Sub-I in developing statistical methods and models to analyze and report data based upon study requirements. Perform site observation visits for applicable staff and develop performance improvement plans; oversee clinical monitoring metrics.

 

 

Work Location: 505 Jenkins Street, LaGrange, Georgia 30240

 

Minimum Requirements:

 

Education: Master – Biotechnology (will accept foreign education equivalent)

 

Experience: One (1) year