Company: SGS North America
Posted on: September 23, 2022
Company Description -SGS is the global leader and innovator in
inspection, verification, testing and certification services.
Founded in 1878, SGS is recognized as the global benchmark in
quality and integrity. With over 97,000 employees in 130 countries
and operating a network of more than 2,400 offices and
laboratories, we provide services to almost every industry by
assuring quality and safety of products and services.Trusted all
over the world, SGS is a market leader because we put 100% passion,
pride and innovation into everything we do. We encourage new ideas.
We welcome people who challenge the way we do things. And we will
be 100% committed to helping you reach your full potential.Job
- The Clinical Investigator 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 FunctionsReasonable accommodations may be made to
enable individuals with disabilities to perform the essential
- 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
- -Develops, maintains and reviews Standard Operating Procedures
- 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
- Delegates duties, as appropriate. Ensures that all individuals
working on the study have necessary credentials, are adequately
trained, understand their obligations and are properly
- Provides a sufficient number of trained staff members to be
assigned to each study. Maintains training records of staff
- -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
- -Maintains a safe and hygienic facility.
- -Handles any unanticipated occurrences on a case-by-case
- -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
- Must possess a PhD, M.D., D.O., or similar post-graduate degree
in Science, Medicine, or Engineering AND
- 7+ years of experience in a related field -Preferred:
- -Dermatology background, sunscreen and cosmetic testing
experience a plus
- -10+ years of experience in a related fieldLicenses/
- None requiredKnowledge/ Skills/ Abilities
- Language Skills: English - Advanced level required
- -Mathematical Skills: Intermediate at a minimum. Advanced level
- -Reasoning Skills/Abilities: Advanced level required
- -Computer Skills: Microsoft Office (Word, Excel and PowerPoint)
- Intermediate user proficiency required
- -Ability to maintain confidentiality
- -Effective communication, written and verbal skills
- Strong attention to detail
- -Well organized with a sense of responsibility for project and
- -Ability to work in a fast-paced environment
- -Strong ability to balance multiple priorities and produce
- -Excellent communication skills (verbal, written and
presentation)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.
Keywords: SGS North America, Richardson , Clinical Investigator, Other , Richardson, Texas
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