Primary Responsibilities

Develops and enhances quality processes to promote, facilitate and ensure compliance with all regulatory and company standards by

• Reviewing, approving and analyzing both internal and external compliance related issues and reports, corrective and preventive actions (CAPA), deviations and notes to file (NTF).
• Ensuring all compliance issues are tracked and trended as well as closed in a timely manner
• Performing all functions of both internal and external quality assurance (QA) audits including audit initiation, conducting the audit, issuing an audit report with pertinent observations/findings, and ensuring corrective and preventive actions resulting from the internal audit are appropriately tracked/trended and resolved accordingly
• Tracking and reporting data errors detected during review processes
• Communicating effectively, verbally and in writing, with all internal and external clients
• Escalating quality concerns and problems to the Manager, Quality and Regulatory Affairs or designee(s)
• Performing QA review of source documents, case report forms (CRFs), offsite shipments and other reports for accuracy as needed

Designs, develops, implements, and assists in management of all quality assurance programs by

• Assisting the Manager, Quality and Regulatory Affairs with identifying and implementing process enhancements to BioClinica’s quality systems and processes through appropriate stakeholders
• Conducting external (vendor/supplier) quality audits and hosts Sponsor audits as needed
• Developing applicable BioClinica training guidelines and SOPs with other stakeholders as needed
• Training peers on all functions of the internal/external audits and compliance reporting programs as needed

Performs supervisory functions by

• Communicating job expectations
• Planning, monitoring and appraising job results
• Coaching, counseling and disciplining staff
• Initiating, coordinating and enforcing systems, policies and procedures

• Approving direct reports time sheets, requests for time off and/or overtime
• Performing timely performance evaluations of direct reports
• Coordinating and conducting new hire interviews; facilitating hiring decision
• Training new hires on departmental processes and responsibilities

Maintains Quality Service and Departmental Standards by

• Reading, understanding and adhering to organizational Standard Operating Procedures (“SOP”)

• Assisting in establishing and enforcing departmental standards

Secondary Responsibilities

Contributes to team effort by

• Working with internal staff to resolve issues
• Exploring new opportunities to add value to organization and departmental processes
• Helping others to achieve results
• Performing other duties as assigned

Maintains Technical and Industry Knowledge by

• Attending and participating in applicable company-sponsored training
• Attending educational workshops and reviewing professional publications
• Keeping informed of changes in the regulatory environment and/or regulatory requirements

Qualifications:

Education:

• Bachelor’s degree in science or related field required
• Quality Auditor certification, or equivalent, is preferred

Experience:

• 5+ years relevant experience in areas of Quality Assurance, Inspection, or Auditing
• Possesses a strong working knowledge of Good Clinical Practices (GCP), Quality/Regulatory Guidelines, and is competent with quality control procedures including acceptance criteria
• Computer literate and familiar with most common software applications (i.e., Word, Excel etc.)
• Understanding of medical and/or clinical trial terminology is desirable

Additional skill set:

• Ability to work in group setting and independently; ability to adjust to changing priorities
• Excellent attention to detail and orientation toward meticulous work
• Strong interpersonal and communication skills, both verbal and written
• Strong documentation and organizational skills
• Ability to project and maintain a professional and positive attitude

Working conditions:

Travel:  0-15%

Lifting:  0-20 lbs.

Other:  Computer work for long periods of time

EEO Statement

Bioclinica is an equal opportunity employer.  Bioclinica evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.