Clinical Investigator

The Clinical Investigator, CRS oversees the clinical research of consumer products involving healthy paid volunteers. Develops research studies and creates standards and guidelines for clinical research services and programs. Ensures adherence to standard operating procedures, good clinical practice and FDA regulations.JOB FUNCTIONSOversees the clinical research of consumer products involving healthy paid volunteers.Reviews protocols, collects and reviews data, prepares progress reports, analyzes results, writes summaries and conclusions and reviews reports.Trains on and performs clinical grading to assess subjects skin conditions.Conducts and / or supervises studies in accordance with the protocol and SOP’s.Protects the rights, safety and welfare of subjects.​​​​Interfaces with the Sponsor, staff, contractors, professional societies, Institutional / Investigational Review Board (IRB), subjects, government agents / agencies and other business units. Obtains appropriate information, documentation and signatures.Notifies the Sponsor and / or IRB of any changes to or deviations from the protocol and document changes and deviations.Delegates duties, as appropriate. Ensures that all individuals working on the study have necessary credentials, are adequately trained, understand their obligations and are properly supervised. Ensures that the Informed Consent (IC) is clear and accurate so that subjects can understand the IC. Provides the opportunity for subjects to ask questions about the IC. Ensures that subjects have signed the IC.Maintains appropriate accurate and complete records of test materials, including amount received, amount dispensed and disposition, both current and historical. Assures confidentiality of records.Maintains a safe and hygienic facility.Handles any unanticipated occurrences on a case-by-case basis.Notifies the Sponsor and the IRB about Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Reactions (ARs).  Follows events and reactions to resolution.Maintains Quality Assurance (QA). Ensures that QA Department is fulfilling all job duties.Provides reasonable medical care for any medical problems that are related to the research.Instructs employees on the confidentiality aspects of analytical reports and information.Possesses knowledge and complies with applicable FDA / Governmental / International regulations.Adheres to internal standards, policies and procedures.Performs other duties as assigned.