Work Schedule

Environmental Conditions

Job Description

Conduct and/or lead complex internal (database, clinical study report, study file, process) and external (clinical investigator site and vendor) GCP 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. May perform technical document review and other GCP activities in support of clinical development programs. Provide audit reports to management. Plan and deliver quality services including contracted quality assurance, GCP audits for clients and clinical trial projects. 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.

Qualifications:

Education and Experience:

Bachelor's degree strongly preferred; equivalent will be considered.

Previous QA and GCP auditing experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years) or equivalent combination of education, training, & experience.

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.

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

Knowledge, Skills and Abilities:

• Thorough knowledge of GCP and appropriate regional regulations. Other GxP knowledge is a plus.

• Extensive knowledge of the clinical trial process

• Demonstrated proficiency and led a range of GCP study-specific audits (site, eTMF, database, and Clinical Study Report) and/or other GxP audits, including process and vendor audits

• Solid experience in root cause analysis and CAPA development

• Thorough knowledge of procedural documents

• 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 skills, risk assessment and impact analysis abilities

• Above average negotiation and conflict management skills

• Strong organizational and time management skills including ability to multitask and prioritize competing demands/workload

• Proven flexibility and adaptability

• 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 is a plus:

• Experience hosting client audits and/or regulatory inspections.

• Experience delivering training.