Clinical Quality Assurance Specialist (Part time)

Job#: 3040158

Job Description:

Clinical Quality Assurance Specialist (Part time)

Rapidly growing clinical testing company in Phoenix is expanding their team with a part time Clinical Quality Assurance Specialist. This onsite position will work approximately 25 hours per week, Monday - Friday during the day with some schedule flexibility.

We are interested in individuals who excel with attention to detail. Strong interpersonal and communication skills are a must. This role will be up to 90% documentation review and other QA responsibilities including observation of clinical study activities.

Job Summary:

Complete routine QA activities directly related to the performance oversight of Clinical Research Studies to Good Clinical Practices (Google Cloud Platform), including review and approval of protocols, procedures, data, and associated reports. Maintains instrumentation qualification and periodic calibration information to assure continued compliance. Assist Clinical Quality Assurance Management and Quality Assurance Management on special projects.

Duties:

Review and approval of raw data and associated clinical reports for accuracy and compliance to Google Cloud Platform requirements.

Ensure that all Clinical activities are carried out in accordance with SOPs and Good Clinical Practices (Google Cloud Platform), and following the guidance of the Principal Investigator.

Conduct Study Binder review and approval.

Conduct In-Process Auditing.

Act as liaison between Clinical and QA Document Control to manage the administration of controlled Clinical documents including standard operating procedures, protocols, forms, and supporting documents.

Assist Clinical personnel with review and approval of Clinical controlled documents.

Revise procedures relevant to job description and expertise.

Act as Clinical Document Control Administrator for Electronic Quality Management System.

Maintain document revision activity and files of completed Document Change Records (DCRs) and other quality system documentation, as applicable, while proactively managing documents through their lifecycle at Clinical facilities.

Maintain archives of completed Clinical Notebooks, Study Binders, and Master Documents, including interactions with external archival storage facilities, as necessary.

This includes, verification of items for archival, scheduling of archive pick-up and retrievals, and confirmation of destruction activities in compliance with retention policy.

Generate and issue clinical notebooks to enable compliant data recording.

Set-up new employees and ensure appropriate maintenance of training record files for clinical employees, as necessary.

Review and approval of instrument calibration / validation documents.

Ensure applicable monitoring of Study-related environmental conditions, temperature controlled units, and associated investigations, as applicable.

Perform review / approval of Deviations, Corrective / Preventive Action (CAPA) proposals and other quality related requests as assigned.

Perform Clinical Internal Audits, as assigned, and follow up to ensure corrective actions are addressed and evaluated for effectiveness in a timely manner.

Assist with Client Audits of Clinical facilities, as applicable.

Perform all duties following current SOP's and ensure all procedures applicable to Clinical Operations are followed.

Work with QA Management on special projects, as assigned.

Perform other duties as assigned.

Qualifications:

BS degree in an applicable scientific discipline OR comparable GMP industry experience in a quality assurance role is desired.

Two years of relevant experience in a clinical or quality oriented role, preferably within an FDA regulated industry is preferred.

Reliable with a strong commitment to quality.

Multi-tasking and team player.

Organized, detail oriented, competent, and responsible.

Good technical writing and communication skills.

MS Excell and Word skills are needed.

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or .

Everforth Apex is a world-class IT services company that serves thousands of clients across the globe. When you join Everforth Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRateds Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico.

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Everforth Apex Benefits Overview: Everforth Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Everforth Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Everforth Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Everforth Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our 'Welcome Packet' as well, which an Everforth Apex team member can provide.

Everforth Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Everforth Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.

If you require an accommodation under the Americans with Disabilities Act to participate in an interview with a virtual recruiter or to use our website for a search or application, please contact our Benefits Department at or . Please note that this contact information is strictly to be used for medical ADA accommodations and that no other inquiries will be answered.

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