Qualified candidates must have *dermatologist* experience and *clinical trial investigator *experience.*Role and Responsibilities*Administrative* Serve as Principal Investigator or Sub-Investigator on assigned clinical trials* Provide medical monitoring for clinical studies* Responsible for the safety and well-being of the volunteer subjects* Acts as part of a multidisciplinary team to provide continuity of care to patients throughout various stages of treatment on protocol and follow-up* Prepare clinical development plans and institute properly approved clinical protocols* Contribute and support department / clinical initiatives to improve the quality and content of all clinical programs* Provide medical expertise to Clinical Operations activities for safety amendments* Responsible for the performance, quality and oversight in clinical trials* Assist in preparation of abstracts, manuscripts and presentation for meetings* Conduct and assess clinical safety and efficacy data and write clinical study reports* Coordinate and provide medical training including indication training, protocol training, safety presentations for clinical staff, project teams, or during meetings* Provide input for weekly status reports* Review and approve protocols, case report forms, informed consent forms, and other study documentation* Review and approve final study reports or other clinical documents* Ensure optimal study conduct* Assist in organization, coordination, and execution, as required, of internal and external meetings* Actively contribute to developing and reviewing Standard Operating Procedures and Working Instructions in the role of process owner and subject matter expert* Actively contribute to the validation and implementation of new systems, instruments methods and assessments* Lead and actively participate in the training and coaching of on-call staff and new and less experienced colleagues* Support medical affairs activities involving product evaluation, labeling and surveillance*Professional Demonstrates initiative and responsibility* Able to perform repetitive tasks without loss of focus* Adheres to ethical principles* Time Management* Adapts to change* Attends all team meetings and mandatory in-service training / education*Communication Recognizes and respects cultural diversity* Adapts communication to individual’s ability to understand* Uses professional, pleasant tele etiquette* Uses medical terminology appropriately* Treats all patients and co-workers with compassion, empathy, and mutual respect* Projects a professional manner and image* Consistent attendance and punctuality* Adherence to time clock procedures*Legal Maintains confidentiality and documents accurately* Uses appropriate guidelines for releasing patient information* Practices within the scope of education, training, and personal capabilities* Conducts self in accordance with Suncoast’s Employee Handbook.
Maintains awareness of federal and state health care legislation and regulations; OSHA, HIPAA, and CLIA*Physical Demands Prolonged sitting / standing / walking* Multitasking position* Repetitive head, neck, hands wrists and arm motion / rotation* Extensive reading, writing, typing required.
Typing speed 45wpm +* Lifting to 25lbs* Frequent use of office administrative, computer, and equipment*Qualifications and Education Requirements : Medical Degree and broad-based post-graduate experience* Medical board certification preferred* A minimum of 3 or more years of experience in a clinical research position* Good Clinical Practice (GCP) certificate* Ability and willingness to travel as required* Excellent Communication Skills* Excellent presentation skills