Clinical Auditing Specialist II Vendors and Information System Audits

Work Schedule

Environmental Conditions

Job Description

What Youll Do:
Conduct and/or lead a variety of GxP qualification and routine vendor audits as requested by senior management including but not limited to on-site virtual and remote audits of service providers used in clinical trials with or without technology components
Perform directed vendor audits
May perform clinical investigator site
Provide GxP consultation and support to internal and external clients
Serve as a knowledgeable resource to operational departments on audit or quality assurance subject matter
Prepare and present audit findings and/or other related information at departmental internal operations or client meetings

Education and Experience:
Bachelors degree or equivalent and relevant formal academic / vocational qualification
Previous QA and GxP vendor auditing experience that provides the knowledge skills and abilities to perform the job (comparable to 3 years).

In some cases an equivalency consisting of a combination of appropriate education training and/or directly related experience will be considered sufficient for an individual to meet the requirements of the role.

Knowledge Skills and Abilities:
Solid knowledge of the clinical trial process

Thorough knowledge of GxP and appropriate regional research regulations and guidelines
Demonstrated proficiency and led a range of GxP vendor audits to high standards required by management
Excellent oral and written communication skills (including appropriate use of medical and scientific terminology)

Strong attention to detail

Effectively works independently or in a team environment
Highly developed problem solving risk assessment and impact analysis abilities
Solid experience in root cause analysis and CAPA development
Above average negotiation and conflict management skills
Proven adaptability

Strong organizational and time management skills including flexibility and ability to multi-task and prioritize competing demands/workload
Strong computer skills; ability to learn and become proficient in appropriate systems

Fluent in English

Valid drivers license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel

The following is a plus:

Experience performing other types of QA audits or activities (e.g. investigator site audits database audits clinical study report audits sample results tables process improvement)
Experience hosting client audits and/or regulatory inspections.

Experience delivering training.

Working Conditions and Environment:
Work is performed in an office/ laboratory and/or a clinical environment.
Exposure to biological fluids with potential exposure to infectious organisms.
Exposure to electrical office equipment.
Personal protective equipment may be required such as protective eyewear garments and gloves.

Physical Requirements:
Ability to work in an upright and /or stationary position for 6-8 hours per day.
Repetitive hand movement of both hands with the ability to make fast simple repeated movements of the fingers hands and wrists.
Frequent mobility required.
Occasional crouching stooping with frequent bending and twisting of upper body and neck.
Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
Frequently interacts with others to obtain or relate information to diverse groups.
Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
Regular and consistent attendance