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Actalent Clinical Trials Specialist in Tarrytown, New York

Description:

Clinical Study Specialist (CSS) provides technical and administrative support to the clinical study team(s) responsible for clinical trial execution. Assigned to support the execution of one or more studies across a program. Support internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs).

Responsibilities

  • Organizes and delivers reports and metrics

  • 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 re-portable changes, financial disclosure form)

  • Contributes to line listings review for Blind Data Review Meeting (BDRM)

  • Tracks and monitors close out activities – study close-out documents (1572s, Investigational Product reconciliation, Financial Disclosures, etc.) and CRA close-out visits

Additional Skills & Qualifications:

  • 3+ Years of Clinical Trial Experience (Pharma/Biotech or CRO only)

  • 2+ years of managing Trial Master File

  • 2+ Experience supporting CTMs on CRO management

  • 2+ years of Taking Meeting Minutes

  • Associate/Bachelors Degree minimum

    About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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