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Job Title: Clinical Study Associate I

Type: Contract - 1 year

Contractor Work Model: Hybrid - must be able to go onsite 1-4 times/week

Are you a detail-oriented professional looking to make a significant impact within the life sciences industry? Joule is currently seeking a Clinical Study Associate to join an industry-leading client in Bridgewater. This is a high-visibility role where your expertise in Trial Master File (TMF) integrity will directly support the success of critical clinical trials.

As a Clinical Study Associate, you will serve as a key pillar of the clinical operations team. You won't just be managing documents; you will be ensuring the "health" of the trial through meticulous reconciliation and quality oversight.

+ Assist in planning and execution of clinical studies, under the close supervision of a Senior Manager (or above) within Clinical Operations.

+ Key focus is on providing clinical administrative support to study teams and on interacting with the Contract Research Organizations (CROs) and other vendors conducting the study to help monitor compliance with Quality Oversight measures.

+ Support and assist the transmittal of trial and site level document to the Document Control Center (DCC) in support of the Trial master File (TMF).

+ Reconcile the TMF document trackers generated by the CRO with the document archive. Bring issues with the reconciliation to the attention of the supervisor.

+ Track study metrics such as site start-up, Investigator/site performance, recruitment, regulatory documents, TMF filing and QC activities and elevate areas of concern to the supervisor. Create/maintain spreadsheets to track other items as needed, (e.g. Vendor invoices).

Skills:

+ Minimum of 1-year relevant experience is required.

+ Veeva experience is a plus.

+ Oncology experience is a plus.

+ Working skills in computer applications, such as Microsoft Word, Excel, PowerPoint, and Outlook. Basic oral and written communication skills.

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System One, and its subsidiaries including Joulé, ALTA IT Services, 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.

#LI- EL1

Ref: #568-Clinical

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.