Quality Assurance Coordinator II (Clinical Research)

About Us:

Each of CenExel's research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success.

Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k.

Job Summary:

Ensure that highest standards of data quality and study participant safety are maintained, as well as adherence to study protocols, CenExel SOPs, Site Working Practices (WPs), ICH GCP, Code of Federal Regulations, and IRB Guidelines.

Compensation : $27.15 - $35.50/h depending on education, experience, and skillset.

Essential Responsibilities and Duties:

• Assists the QA Manager in the development, implementation and follow-up of quality assurance programs including necessary or appropriate policies and guidelines
• Reviews follow-up monitoring visit reports, protocol deviation logs, and quality findings trackers for trend analysis.
• Performs ongoing review of a percentage sampling of study inclusion/exclusion, study procedure records, and laboratory reports to ensure that they are conducted according to the protocol, applicable SOPs, ICH/GCP guidelines and federal regulations.
• Performs quality review of initially created source documentation, including amendments, to ensure all protocol required procedures are present.
• Provides training and education on SOPs, GCP, and federal regulations as appropriate.
• Prepares for internal and external audits and FDA inspections.
• Attends staff meetings.
• Attends site initiation visits, as needed.
• Supports and ensures strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site working Practices, protocol, and company guidelines and policies.
• Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.

Education/Experience/Skills:

• Must be able to effectively communicate verbally and in writing.
• Must have proper experience and demonstrate mastery of Quality Assurance Coordinator I position.
• Minimum 2 years quality assurance experience.
• Knowledge/Skills/Abilities: Must be self-directed and able to work with minimal supervision; Must have in depth knowledge of FDA regulations. GCP, and ICH guidelines; Able to take a flexible approach to shifting priorities; Able to manage multiple projects and responsibilities; Motivated to work consistently in a fast paced and rapidly changing environment; Must be detail oriented and have exceptional computer, organizational, and communication skills - both written and oral.
• Must reflect the professional image of the company, upholding the company vision in actions, demeanor, and appearance.
• Must be able to clearly communicate through written and verbal means with sponsors and staff.

Working Conditions

1. Indoor, Office environment.
2. Essential physical requirements include sitting, typing, standing, walking.
3. Lightly active position, occasional lifting of up to 20 pounds.
4. Reporting to work, as scheduled, is essential.
5. On site work arrangement.

CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.

Equal Opportunity Employer
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