Quality Assurance Specialist

Science 37 accelerates clinical research by expanding patient access to trials, leading to faster approvals and better health outcomes for all. Our solutions empower life sciences companies to reach diverse populations beyond traditional means of conducting clinical research

POSITION OVERVIEW

The Quality Assurance Specialist will participate in continuous improvement of the quality system framework at Science 37 by assisting with the creation of and executing quality audit plans, supporting the identification and remediation of identified trends, overseeing the vendor management program, and executing computer system validation activities. This position provides daily, quality oversight of the conduct of clinical trials at Science 37. This position reports to the Director, Clinical Quality Assurance.

DUTIES AND RESPONSIBILITIES

Duties include but are not limited to: Leading and/or participating in client audit preparation, hosting, and follow-up. Supporting the identification and implementation of continuous improvement opportunities and initiatives. Assisting with the development and refinement of SOPs governing clinical and quality operations. Assisting with the creation and execution of the internal clinical quality audit plans. Conduct and participate in internal audits of Science 37 cGXP Departments (e.g., Clinical Operations, Nursing Solutions, Medical Affairs). Owning and executing the Vendor Management and Quality programs. Remain abreast of current regulations and industry best practices in clinical trials. Participate in Quality Organization improvement projects as required.

QUALIFICATIONS & SKILLS

Qualifications Bachelor’s Degree in science or other related field required 2+ years of experience in clinical research or other GxP environment Proven track record of cross functional collaboration Knowledge of cGXP regulations, Quality Management Standards (e.g, ISO 9001). and current industry best practices Excellent written and oral communication skills Ability to meet deadlines in a fast-paced environment Excellent interpersonal skills and savvy – Understands interpersonal and group dynamics and reacts in an effective and tactful manner. Has a range of interpersonal skills and approaches with ability to select a best-fit approach. Strong organizational skills – ability to adapt to a rapidly changing work environment and remain in control of various projects and changing priorities. Strong creative problem-solving skills and the ability to exercise sound judgment and make decisions based on accurate and timely analyses. Ability to provide guidance and structure while encouraging innovation. Experience developing, implementing, and maintaining electronic quality management systems, direct experience with Compliance Quest desired. Capabilities Ability to communicate in English (both verbal and written) **First 6 months of the role will be 5 days a week in our Morrisville Office. Post 6 months you will transition to a hybrid schedule Mon, Wed & Thurs in office and Tues & Fri remote.** Science 37 is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. Science 37 values the well-being of its employees and aims to provide team members with everything they need to succeed. Voluntary Self-Identification For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file. As set forth in Science 37’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law. If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows: A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. #J-18808-Ljbffr Science 37