Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Conduct complex internal and external Clinical Research Site audits to ensure compliance with established quality assurance processes, standards, global regulatory guidelines, and client contractual obligations. Identify issues impacting the quality and/or integrity of clinical research programs, determine root cause of non-conformance and develops strategies to address issues. Perform technical document review and other GCP practice activities in support of clinical development programs. Provide audit reports to management. Plan and deliver quality services including contracted quality assurance audits, internal site audits, laboratory and file audits for clients and projects. Lead process/quality improvement initiatives. Mentor peers. Develop tools and other materials for tracking of compliance management activities and analyze trends. Upon request, support regulatory inspections and/or client audit hosting.
Qualifications:
Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous Clinical Site Auditing experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years) or equivalent combination of education, training, & experience.
- Must have GCP and auditing experience for clinical trials, in order to qualify for this role! ***
Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.
Knowledge, Skills and Abilities:
- Thorough knowledge of applicable GCP and appropriate regional regulations. Other GCP knowledge is a plus.
- Strong knowledge of the clinical trial process
- Experience with study-specific (investigator site) audits or other GP audits, could also include process and vendor audits
- Experience in root cause analysis and CAPA development
- Well-rounded knowledge of SOPs and WIs
- 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
- Strong problem-solving skills, risk assessment and impact analysis abilities
- Above average negotiation and conflict management skills
- Flexible and able to multitask and prioritize competing demands/workload
- Strong computer skills; ability to learn and become proficient with appropriate software
- Valid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel
The following experience is a plus:
- Hosting client audits and/or regulatory inspections.
- Auditing database, eTMF, and Clinical Study Report
- Training/mentoring of peers
Management Role:
No management responsibility
Working Conditions and Environment:
- Work is performed in an office/laboratory/clinical environment.
- Exposure to electrical office equipment.
- May require use of personal protective equipment required such as protective eyewear, garments, and gloves.
- Occasional drives to site/office locations with up to 50% travel both domestic and international.
Physical Requirements:
- Frequently stationary 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, 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.
- Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration.
- 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.
