Clinical Quality Assurance Specialist (Remote) - CLINI002928-00001

DESCRIPTION/RESPONSIBILITIES: As a member of the ACR team, you will:    * Perform Good Clinical Practice (GCP) internal audits (study, process, software systems, etc.). Including production of audit plans, reports, collecting responses, and follow-up; * Participate in hosting inspections (e.g., FDA and external audits by sponsor).  Including communication with agency/sponsor, internal audit preparation activities, review of audit report, collection of responses, and follow-up on findings resolution; * Participate in vendor qualification audits as assigned.  Including production of audit plans, reports, collection of responses, and follow-up; * Assist in developing, recommending, and monitoring corrective and preventive actions; * Support the development (writing) and periodic review of standard operating procedures and work instructions for different functional areas; * Assist project teams with developing and maintaining eTMFs for each project; * Conduct Good Clinical Practices (GCP), 21 CFR Part 11, and other internal trainings as required; * Participate in continuously improving and maintaining our quality management system and assist with compliance activities; * Serve as a source of advice and guidance on all quality/GCP and other regulations matters for internal staff.

Qualified candidates will possess the following: * 2+ years of Good Clinical Practices (GCP) related experience required; auditing experience is preferred; * Bachelor's degree required; * Certification as a Quality Auditor or related certificate is a plus; * Thorough knowledge of GCP, and relevant regulations for the conduct of clinical trials including 21 CFR Part 11, 50, 312, 812, 820; * Experience with Electronic Documentation Management System (EDMS) and Electronic Master File system (eTMF); * Exceptional technical writing, review, and analytical abilities; * Excellent communication and interpersonal skills.  Must be assertive, but diplomatic; always striving for win-win situations; * Strong MS Office skills necessary.

If you would like to put your experience to great use in a professional team-oriented environment, please apply online. To learn more about ACR's rewarding employee experience, culture, and benefits, visit: https://www.acr.org/About-ACR/Work-With-Us

ACR is committed to a total rewards compensation philosophy that includes base salary in addition to our full suite of comprehensive benefits (https://www.acr.org/-/media/ACR/NOINDEX/HR/ACR-Benefits-Overview.pdf).  ACR's goal is to pay competitively and equitably.  It is typical for individuals to be hired in the entry to middle of the range for their role, and compensation decisions depend on each case's circumstances.  A reasonable estimate of the range is $60,050--80,050.

ACR offers a rewarding employee experience: innovative culture, professional growth potential, competitive compensation, and an exceptional benefits package, including a defined contribution pension plan, 403(b); generous paid time off package; insurance plans with the leading providers; flexible spending; tuition reimbursement; training opportunities; and wellness reimbursement. 

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation condu ted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)

Equal Opportunity Employer-minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity