Senior Clinical Investigator
SGS Posted on 2022-11-18
| Salary | Not mentioned |
|---|---|
| Location | Richardson, TX 75081 |
| Type | Full-time |
Job 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.
Summary
- The Associate Director of Science and Innovation oversees the clinical research of consumer products involving healthy paid volunteers. The scope of the role includes the development of research studies and the creation of standards and guidelines for clinical research services and programs, while ensuring adherence to standard operating procedures, good clinical practice and FDA regulations.
Job Functions
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential 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).
- 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.
- 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, 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.
- 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.
- Provides reasonable medical care for any medical problems that are related to the research.
- Provides general direction, motivates and manages subordinate staff in the day-to-day job performance.
- May have full supervisory responsibility of direct and indirect reports (hiring: interviewing, selection; planning work, scheduling, performance evaluations, performance management and termination)
- 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.
Education and Experience
Required:
- 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
- 5+ years of managerial experience
- Dermatology background, sunscreen and cosmetic testing experience a plus
Licenses / Certifications
- N/A
Knowledge / Skills / Abilities
- Language Skills: English Basic level of knowledge required; other languages are a PLUS
- Mathematical Skills: Intermediate skill level preferred with familiarity with statistics
- Reasoning Skills/Abilities: Advanced level required
- Computer Skills: MS Office Suite – Basic user proficiency preferred
- Ability to work in team environment and maintain professional behavior
- Excellent communication skills
- Attention to detail
- Ability to work in a fast-paced environment
- Strong ability to balance multiple priorities and produce results
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.
Company description:
You know those little stickers that say « Inspected by 2438 »? Meet 2438. SGS North America, a division of global testing and verification giant SGS, offers technical services such as product testing, conformity assessment, quality inspection, product safety inspections, design reviews, statutory certification, quality assurance, environmental impact, and consultancy. SGS North America tests everything under the sun, and targets such industries as power generation and transmission, oil and gas refineries and pipelines, metals and minerals, agriculture, transportation, construction, aerospace, pharmaceuticals, and industrial manufacturing. Whether or not goods are being imported to the US or exported from it, SGS North America »s Trade Assurance Services division helps governments with customs classification and import verification services to comply with international trade and environmental regulations. SGS North America »s biggest moneymaker is its Oil, Gas & Chemicals division that tests petrochemicals, packages and ships samples, and provides measurement and calibration services. It handles inspection services for such oil companies as Chevron, Exxon Mobil, Marathon Oil, and Valero. The company »s Environmental Services division has laboratories and drilling offices located throughout the US. SGS North America inspects for thousands of other customers such as Subaru, Honeywell, Shell Chemical, and Kaiser Aluminum.
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