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Title: CEC Clinical Trial Coordinator

Schedule: Monday through Friday (local hybrid)

Duration: contract to hire

Education:

Bachelor’s degree

Requirements:

Proficiency in MS Office products (Outlook, Word, Excel, and PowerPoint) and familiarity with databases

Possess strong interpersonal skills to effectively communicate with cross functional teams including staff at all levels of the organization

Ability to successfully negotiate and collaborate with others of different skill sets, backgrounds and levels within and external to the organization

Strong problem solving and negotiation skills

Requires minimal direction from leadership and possesses the ability to learn quickly

Responsibilities

Review source documents submitted by investigative sites for potential endpoint events to ensure documents were uploaded to the correct event in the electronic adjudication system (EAS).

Provide a hyperlink to client's secure file transfer protocol (sFTP) to investigative site personnel for source document transfer if the EAS is unavailable, not being used for the trial, or site personnel do not have access.

Enter and track events and event statuses for trials not utilizing electronic adjudication into an Excel database.

Submit documents to the designated translation vendor for translation into English and enter the submission into the translation tracker as directed.

Perform a quality review of translated documents to ensure PII has been completely redacted by the vendor. Notify the CEC Lead Coordinator or Sr. Project Manager of redaction oversights. Track, and redact the information following trial-specific conventions. Review translated source documents for potential treatment unblinding information and redact information if identified. Track any findings following trial-specific conventions. Compile the event dossier consisting of submitted source documents and the patient profile report downloaded from the designated location provided by the pharmaceutical sponsor/sponsor vendor.

Advance events through the adjudication workflow following trial-specific procedures.

Submit events to the assigned Medical Reviewer (MR) and process any queries to the investigative sites following trial-specific procedures. Submit MR-approved events for adjudication at the scheduled CEC meeting. Process adjudicator queries for additional information following trial-specific conventions.

Utilize the adjudication system’s audit trails to identify changes made to events before and after adjudication.

Participate in system validation by performing user acceptance testing (UAT) pre-system go-live and for system changes for the trial’s duration.

May assist in the training and orientation of new staff/trial-team members.

Assist in the scheduling of CEC meetings using MS Teams

#m3

Ref: #558-Scientific

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services 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 full-time 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.