Clinical Study Specialist
Warren, NY
Compensation: $35 - $40 hourly depending on experience 
Term:  1 year contract (can be renewable)

Job Description:
The Clinical Study Specialist (CSS) provides technical and administrative support to the clinical study team(s) responsible for clinical trial execution. The CSS may be assigned to support the execution of one or more studies across a program. The CSS receives assignments from the Clinical Study Lead or Clinical Study Associate Manager. The CSS will support internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs).
This role is an onsite role in one of our office locations and is NOT eligible fully remote.
In this role, a typical day might include the following: Organizes and delivers analyzable reports and metrics to the clinical study lead Schedules and coordinates meetings, prepares agendas, presentation materials and minutes for clinical study team meetings and other study related meetings Collates data for assessments such as feasibility and site selection and reviews site usability database Contributes to review of study documents such as informed consent forms, case report forms and facilitates study document reviews per company standard operating procedures Compiles study manuals including but not limited to study reference binders and manuals and maintains versioning of study reference materials (e.g., regulatory, pharmacy, and laboratory binders Collates materials for training and investigator meetings Tracks site activation, enrollment and monitoring visits to projected plans, and escalate any issues or delays with site activation or deviations from monitoring plan Monitors and updates investigator/site status for the trial, and supports with clinical trial registry postings Performs scheduled reconciliations of study Trial Master File (TMF) with clinical study lead guidance Ensures scheduled reports are received (i.e.,1572 reportable changes, financial disclosure form) Manages and maintains team SharePoint and/or shared drive sites, as needed Communication with sites as directed and maintains site contact information Contributes to line listings review for Blind Data Review Meeting (BDRM) May manage or contribute to oversight of Third-Party Vendors (TPV) Tracks and monitors close out activities – study close-out documents (1572s, Investigational Product reconciliation, Financial Disclosures, etc.) and CRA close-out visits Participates in Standard Operating Procedures (SOPs) revisions or departmental initiatives Proactively recommends process improvement initiatives for the department This role might be for you if: You have a strong attention to details for the ability to track information and deliver on assigned study activities You demonstrate strong communication and interpersonal skills; ability to form relationships internally and externally You are resourceful and to demonstrate problem solving skills You can proactively assess information and investigate impact on clinical trials In order to be considered, a Bachelor’s degree with 2+ years of relevant pharmaceutical industry experience.

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.

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Ref: #568-Clinical
 

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.