Job Title:            Sr. Clinical Trial Associate (CTA)
Remote
Pay rate:  $40/hr + depending upon degree and education

Description:  Clinical Trial Associate, Clinical Operations will be responsible to perform tracking, develop spreadsheets, file documentation (Box / eTMF), and provide support for the Clinical Team.

Responsibilities: Supporting the Study Lead, Project Manager, Clinical Research Associates and Team in the management of clinical trial projects Preparation and maintenance of the Trial Master Files (eTMF) and Investigator Site Files Develop processes to track and optimize clinical activities for Abeona clinical studies Management of shipment/retrieval of study materials Assist the Clinical Study Leads by providing support to Investigator and Team meetings Site assistance with regulatory and IRB document preparation and tracking Assists in the communication / logistics between internal and external team members to ensure current program status and priorities are on track Recognizes potential challenges and supports the Team in problem solving to assist in the resolution or escalation as appropriate Cooperate with different departments to improve business operations Qualifications: University/College Degree (BS/BA) Minimum 6 years relevant experience in Clinical Research for a Sponsor or CRO Demonstrated experience managing projects Progression of clinical trial experience in the pharmaceutical field Experience and Skills:  Ability to manage multiple projects and shifting priorities.  Previous exposure to drug/biological/therapeutic research, particularly in gene therapy is a plus.  Good working knowledge in Good Clinical Practice and ICH Guidelines.  Effective communication (written and verbal), strong interpersonal, and organizational skills.  Must have the ability to function independently, multitask, be flexible, detail oriented, and work effectively on a team with a high degree of professionalism.  Must have experience in effectively troubleshooting and resolving clinical issues.  Computer skills (MS Office, MS Project, EDC, eTMF, etc.).

System One, and its subsidiaries including Joulé, ALTA IT Services, TeamPeople, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.