Jr Clinical Investigator
Jr Clinical Investigator
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Salary Not Disclosed
1 Vacancy
Job Description
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.
JOB 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 SOPs.
- 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 casebycase 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 postgraduate degree in Science Medicine or Engineering AND Required
- 7 years of experience in a related field Preferred
- 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 fastpaced 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.
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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 companys 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 online employment application because of a disability please callfor 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.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
