SGS North America
Principal Investigator / Co-Principal Investigator / Laboratory Manager - Union, NJ
At a glance
Location: US-NJ-Union Map
Posted: 07/07/2019
Closing: 08/06/2019
Degree: Graduate Degree
Type: Full-Time
Experience: Not Specified
SGS North America
Job description

Primary Responsibilities:

• Serve as Principal Investigator and / or Co-Principal Investigator for Clinical Studies (primarily dermal, some ocular) of consumer products involving healthy, paid panelists at the primary laboratory. Assist Senior Principal Investigator, as required.
• Serve as Principal Investigator at satellite laboratory location(s).
• Manage clinical testing laboratories and laboratory staff.

Specific Responsibilities:

• Conduct and / or supervise studies in accordance with the protocol and SOPs.
• Protect the rights, safety and welfare of subjects.
• Write protocols, collect and review data, prepare progress reports, analyze results, write summaries and conclusions and issue reports.
• Maintain and review Standard Operating Procedures (SOPs). Ensure that study personnel have access to SOPs and that SOPs are followed.
• Interface with the Sponsors, staff, contractors, professional societies, Institutional / Investigational Review Board (IRB), subjects, consultants, government agents / agencies and other business units. Obtain appropriate information, documentation and signatures.
• Notify the Sponsor and / or IRB of any changes to or deviations from the protocol and document changes and deviations.
• Delegate duties, as appropriate. Ensure that all individuals working on the study have necessary credentials, are adequately trained, understand their obligations and are properly supervised.
• Provide a sufficient number of trained staff members to be assigned to each study. Maintain training records of staff members.
• Ensure that Informed Consent (IC) documents are clear and accurate so that subjects can understand the IC. Provide the opportunity for subjects to ask questions about the IC. Ensure that subjects have signed the IC.
• Maintain accurate and complete records, both current and historical.
• Assure confidentiality of records.
• Maintain a safe and hygienic facility.
• Handle any unanticipated occurrences on a case-by-case basis.
• Notify the Sponsor and the IRB about Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Reactions (ARs). Follow events and reactions to resolution.
• Maintain appropriate records of test materials, including amount received, amount dispensed and disposition.
• Maintain Quality Assurance (QA).
• Ensure that QA Department is fulfilling all job duties.
• Provide access to reasonable medical care for any medical problems that are related to the research.
• Be familiar with and comply with applicable FDA / Governmental / International regulations.
• Manage clinical testing laboratories and personnel, as assigned.

Job requirements

Required Skills:

• Must possess a Ph.D., M.D., D.O. or similar post-graduate degree and must have sufficient experience in a related field.
• Dermatology background preferred, sunscreen and cosmetic testing experience a plus.
• Will need to maintain a flexible schedule, as needed. (The facility is open Monday – Friday, 8:00 am – 8:00 pm).
• Familiar with Microsoft Office Suite
• Work in team environment and maintain professional behavior
• Effective communication, written and verbal skills
• Strong attention to detail
• Well organized with sense of responsibility for project and time management
• Necessary to have efficient competency to complete assigned projects on time
• Ability to handle multiple competing priorities through effective resource management
• Ability to maintain confidentiality and flexibility
• Must have a sense of urgency

Additional Information:

•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, skill, and/or ability 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.
•SGS is an EOE AA M/F/Vet/Disability employer.
•Qualified applicants will receive consideration for employment without regard to their race, color, religion, national origin, sex, protected veteran status or disability.
•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 be called back shortly. 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.

Principal Investigator / Co-Principal Investigator / Laboratory Manager - Union, NJ