Clinical Research Physician/Investigator
3 weeks ago
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 trialsProvide medical monitoring for clinical studiesResponsible for the safety and well-being of the volunteer subjectsActs as part of a multidisciplinary team to provide continuity of care to patients throughout various stages of treatment on protocol and follow-upPrepare clinical development plans and institute properly approved clinical protocolsContribute and support department/clinical initiatives to improve the quality and content of all clinical programsProvide medical expertise to Clinical Operations activities for safety amendmentsResponsible for the performance, quality and oversight in clinical trialsAssist in preparation of abstracts, manuscripts and presentation for meetingsConduct and assess clinical safety and efficacy data and write clinical study reportsCoordinate and provide medical training including indication training, protocol training, safety presentations for clinical staff, project teams, or during meetingsProvide input for weekly status reportsReview and approve protocols, case report forms, informed consent forms, and other study documentationReview and approve final study reports or other clinical documentsEnsure optimal study conductAssist in organization, coordination, and execution, as required, of internal and external meetingsActively contribute to developing and reviewing Standard Operating Procedures and Working Instructions in the role of process owner and subject matter expertActively contribute to the validation and implementation of new systems, instruments methods and assessmentsLead and actively participate in the training and coaching of on-call staff and new and less experienced colleaguesSupport medical affairs activities involving product evaluation, labeling and surveillanceProfessional
Demonstrates initiative and responsibilityAble to perform repetitive tasks without loss of focusAdheres to ethical principlesTime ManagementAdapts to changeAttends all team meetings and mandatory in-service training/educationCommunication
Recognizes and respects cultural diversityAdapts communication to individual s ability to understandUses professional, pleasant telephone etiquetteUses medical terminology appropriatelyTreats all patients and co-workers with compassion, empathy, and mutual respectProjects a professional manner and imageConsistent attendance and punctualityAdherence to time clock proceduresLegal
Maintains confidentiality and documents accuratelyUses appropriate guidelines for releasing patient informationPractices within the scope of education, training, and personal capabilitiesConducts self in accordance with Suncoast s Employee Handbook.Maintains awareness of federal and state health care legislation and regulations; OSHA, HIPAA, and CLIAPhysical Demands
Prolonged sitting/standing/walkingMultitasking positionRepetitive head, neck, hands wrists and arm motion/rotationExtensive reading, writing, typing required. Typing speed 45wpm +Lifting to 25lbsFrequent use of office administrative, computer, and phone equipmentQualifications and Education Requirements:
Medical Degree and broad-based post-graduate experienceMedical board certification preferredA minimum of 3 or more years of experience in a clinical research positionGood Clinical Practice (GCP) certificateAbility and willingness to travel as requiredExcellent Communication SkillsExcellent presentation skills-
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