QA Coordinator I

CenExel is a leading nationwide clinical research site and patient network serving the life sciences industry. Leading in CNS and early phase studies, our 18 science-led Centers of Excellence deliver the right patients, at the right time, in the right place. Recently acquired by BayPine Capital Partners, our research sites provide unparalleled medical and scientific support in the design and execution of clinical trials. Our world-class PIs, advanced patient engagement strategies, premium data analytics, and integrated operations optimize every step of the clinical trial process.

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:

Reporting to the Regional Quality Assurance Director, this role will 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.

This role will ensure that accepted procedures are followed. Quality Assurance establishes and maintains quality metrics and trends for the site in collaboration with site leadership. These include but are not limited to Quality control oversight, deviations, CAPAs, audit findings, management of the internal audit program, training compliance, vendor management, risk management and documentation control.

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.
• Oversees Quality Control activities for the site and overall QC training.
• Responsible for overall completion of the site’s yearly internal audit program in collaboration with site leadership.
• Reviews follow-up monitoring visit reports, protocol deviation logs, and quality findings trackers for trend analysis to ensure any actions derived are completed and documented.
• Manages the site’s external audits in collaboration with site leadership to ensure audit readiness.
• Responsible for managing vendors for the site.
• Provides overall training in alignment to regulations and local process as needed.
• Oversees training complaince for the site to ensure the site maintains training requirments.
• Manages the site’s CAPAs upon identification to ensure due dates are attained.
• Performs quality review of initially created source documentation, including amendments, to ensure all protocol required procedures are present.
• Responsible for hosting FDA inspection for the site in collaboration with site leadership and applicable subject matter experts.
• Ensures documentation and working practices are updated and reviewed cycles as needed.
• Attends staff meetings.
• Responsible for the site’s yearly completion of the Clinical Quality Management Plan and oversee the Business Continuity plan.
• Responsible for the site’s Quality Assurance metrics reporting.
• 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.
• High school graduate or equivalent, Bachelors degree or equivalent preferred.
• Minimum 1-2 years relevant experience in the clinical research industry.
• 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.