The Jr. 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.
- Oversees the clinical research of consumer products involving healthy paid volunteers.
- Writes protocols, collects and reviews data, prepares progress reports, analyzes results, writes summaries and conclusions and issues reports.
- Develops, maintains and reviews Standard Operating Procedures (SOPs). Ensures that study personnel have access to SOPs and that SOPs are followed.
- 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.
- Provides a sufficient number of trained staff members to be assigned to each study. Maintains training records of staff members.
- 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.