Quality Assurance Coordinator II

CenExel • Marlton, NJ

8d • $30 - $39 • Onsite

About The Position

About Us: 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: Ensure that high standards of data s and subject safety are maintained, as well as study protocols, SOPs/SWPs, ICH/GCP and IRB guidelines, federal regulations are consistently being followed. Compensation : $30-$39/hr depending on experience education and skill set Essential Responsibilities and Duties: Assist the QA Manager in the development, implementation and follow-up of quality assurance programs including necessary or appropriate policies and guidelines Review follow-up monitoring visit reports, protocol deviation logs, and quality findings trackers for trend analysis Perform 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 Perform quality review of initially created source documentation, including amendments, to ensure all protocol required procedures are present Provide training and education on SOPs, GCP, and federal regulations as appropriate Prepare for internal and external audits Attend staff meetings Attend site initiation visits as needed 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. Experience: Minimum 1-2 years relevant 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 Working Conditions Indoor, Office environment. Essential physical requirements include sitting, typing, standing, walking. Lightly active position, occasional lifting of up to 20 pounds. Reporting to work, as scheduled, is essential. 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.

Requirements

• Must be able to effectively communicate verbally and in writing.
• Must have proper experience and demonstrate mastery of Quality Assurance Coordinator I position.
• Minimum 1-2 years relevant experience
• 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

Responsibilities

• Assist the QA Manager in the development, implementation and follow-up of quality assurance programs including necessary or appropriate policies and guidelines
• Review follow-up monitoring visit reports, protocol deviation logs, and quality findings trackers for trend analysis
• Perform 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
• Perform quality review of initially created source documentation, including amendments, to ensure all protocol required procedures are present
• Provide training and education on SOPs, GCP, and federal regulations as appropriate
• Prepare for internal and external audits
• Attend staff meetings
• Attend site initiation visits as needed
• Assumes other duties and responsibilities as assigned.

Benefits

• Health Insurance
• Dental
• Vision
• LTD
• STD
• Life Ins
• 401k

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed