Clinical Trial DirectorProtocol review, implementation, assessment, evaluation for 5 practice locations. Establish the detailed financial goals and projections for the Clinical Research Department, which outline the expected performance/profitability of each individual trial. Define the scope of the project and the nature of the trials to be performed in a manner that applies minimal risk to the subjects. Market the Research Department in a professional and ethical manner. Investigate and present all research opportunities for approval to the Principal Investigator prior to entertaining an agreement. Complete and coordinate feasibility responses, pre-study visits, initial start-up activities, budget and contract negotiation, and execution. Direct the daily operation of the project in a manner that brings it recognition and respect in the general and medical community. Ensure the program meets recruitment and budgeted targets. Ensure the principal focus of each trial is patient outcomes. Ensure any issue of potential risk is promptly reported to the Principal Investigator. Implement all hiring of coordinators, and education and training of all research personnel in ICH/GCP guidelines. Responsible for Quality Assurance auditing of all projects on a constant basis.

Responsible for the rights and safety of clinical research subjects. Review and oversight of new protocols. Ongoing review of all active trials within the BayCare network. Member of SAE committee within the BayCare IRB structure. Monthly meeting commitment to ensure appropriate oversight. Communication and consultation with peer members from diverse backgrounds.

Director of Clinical ResearchOversight of all research staff. Ensure quality and integrity of clinical data. Promote clinical research and professional growth within the Arthritis Center. Become recognized and respected in local community and medical community. Investigate and present research opportunities. Construct successful recruitment and negotiations of study projects. Stimulate media relations. Assure adequate protection of the rights, welfare and safety of all research subjects. Foster respect and interchange between sponsor companies and the Arthritis Center. Follow Good Clinical Practice guidelines. Implement education and training of all research personnel. Ensure ongoing communication from initiation of study projects through completion and evaluation of projects.

Responsible for the coordination, planning, implementation and enrollment of subjects for the purpose of clinical research studies. Organization, tracking and maintenance of all contracts, budgets, and patients. Direct involvement in all phases of study from initial preparations to informed consent, to completion of study procedures. Communicate clearly and effectively with sponsor and CRA with special attention to subject’s respect, privacy, and confidentiality as well as consideration to confidentiality of the protocol. Management of regulatory and sponsor correspondence utilizing Windows 97.