**Clinical Research Quality Control Specialist **


**Job Description: Job Title: Associate Director, Clinical Quality Assurance**


**Location: REMOTE - 50% travel including global travel**

**HQ is based out of New York, NY**

**Reporting to: Director of Clinical Quality Assurance Position**


**Job Description:**


Actively seeking a highly qualified Associate Director, Clinical Quality Assurance that will lead the compliance of Clinical Development operations within the clients quality policy and ensuring all applicable regulations, industry standards, and requirements are met. The successful candidate will facilitate the Clinical Development teams participation in the organizations quality management system where appropriate processes, procedures, and controls are established to ensure that clinical research is conducted accordingly.


**Key Responsibilities:**


+ Support Project Teams with the development of Quality Management Plans relevant to the specific projects.

+ Prepare and assist Project Teams for regulatory inspections and external Sponsor audits.

+ Act as liaison between clients electronic QMS and Clinical Trial Systems development and implementation.

+ Develop and implement QMS compliance assessments for the GCP component of the QMS.

+ Develop and implement an eTMF inspection readiness assessment plan for all IND studies.

+ Participate in executing the audit plan as delegated.

+ Provide training to GCP Operations on best practices and trends as indicated.

+ Oversee implementation of GCP CAPAs and conduct the required effectiveness checks.

+ Perform other tasks as assigned by the manager.


**Education and Work Experience:**


+ Masters or equivalent in Clinical Research and/or Public Health field is required.

+ Minimum 8 years of experience in clinical research, of which at least 3 have been in Quality Assurance, is required.

+ Certification as GCP Auditor and/or Post Graduate Qualification in Quality Management is highly desirable.

+ Qualifications and Skills: Knowledge and understanding of industry standards and research operations as pertinent to vaccine development is required.

+ 2 Experience working with electronic data and records in CFR21Part11 compliant environments is required.

+ Knowledge and understanding of quality management systems is required.

+ Self-motivation, detail-orientation, and ability to handle significant responsibility as well as shift priorities, exercising discretion, and taking initiative to resolve problems is required.

+ Ability to work well with all levels of staff both within an organization, across functions, and across cultures with demonstrated ability to work effectively in cultures and environments other than ones own is required.

+ Excellent written, verbal, and presentations skills are required. Experience as auditor of public health trials is highly desirable.

+ Experience working in remote-, virtual-, global-, teams, is highly desirable.


**Organizational Overview:**


A nonprofit scientific research organization dedicated to addressing urgent, unmet global health challenges including HIV and tuberculosis. Our mission is to translate scientific discoveries into affordable, globally accessible public health solutions. Through scientific and clinical research in Africa, India, Europe, and the U.S., organization is pioneering the development of biomedical innovations designed for broad global access. This organization develops vaccines and antibodies in and for the developing world and seeks to accelerate their introduction in low-income countries. This organizations programs and partnerships are grounded in the regions of the world where the disease burden is the greatest, and their approach emphasizes sustainability. This organizations network of clinical research center partners in Africa and India helps strengthen in-country research capacity and supports the training and education of the next generation of scientists.


\#2


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **Science & Clinical?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.