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Job Description
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.
J OB FUNCTIONS
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.
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.
Qualifications
EDUCATION AND EXPERIENCE
Must possess a PhD, M.D., D.O., or similar post-graduate degree in Science, Medicine, or Engineering AND Required
7+ years of experience in a related field Required
Dermatology background, sunscreen and cosmetic testing experience a plus Preferred
10+ years of experience in a related field Preferred
KNOWLEDGE / SKILLS / ABILITIES
Language Skills: English - Advanced level
Mathematical Skills: Intermediate at a minimum.
Reasoning Skills/Abilities: Advanced level
Ability to maintain confidentiality
Effective communication, written and verbal skills
Strong attention to detail
Well organized with a sense of responsibility for project and time management
Ability to work in a fast-paced environment
Strong ability to balance multiple priorities and produce results
Excellent communication skills (verbal, written and presentation)
ADDITIONAL KSAS
Microsoft Office (Word, Excel and PowerPoint) - Intermediate user proficiency
EQUIPMENT
Ability to use specialized database and specialized software systems.
Additional Information
SGS is an Equal Opportunity Employer, and as such we recruit, hire, train, and promote persons in all job classifications without regard to race, color, religion, sex, national origin, disability, age, marital status, sexual orientation, gender identity or expression, genetics, status as a protected veteran, or any other characteristics protected by law.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge, skills, and/or abilities required.
This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job. Nothing contained herein restricts the company's rights to assign or reassign duties and responsibilities to this job at any time.
If you are applying for a position within the United States and you have difficulty completing the on-line employment application because of a disability, please call 201-508-3149 for assistance and leave a message. You will receive a call back. Please note, this phone number is not for general employment information, but is only for individuals who are experiencing difficulty applying for a position due to a disability.
