Skip to content

Job Openings

Clinical Study Associate II

Basking Ridge, NJ 07920

Posted: 05/30/2024 Employment Type: Contract Job Category: Clinical Development and Operations Job Number: 607784 Is job remote?: No Country: United States

Job Description

Target Pay Rate: 35-55/hr **salary will be commensurate with experience 

Job Description:

  • Assist in planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.
  • Key focus is on providing clinical trial management support to study teams and tracking CRO and other vendor performance against project goals and milestones to monitor and ensure compliance with Clinical Study Oversight Plan (CSOP).
  • Reconcile the TMF document trackers generated by the CRO with the document archive. Bring issues with the reconciliation to the attention of the Study Manager and propose remediation plan.
  • Distribute key study documents to the CRO and vendors as appropriate.
  • Provide clinical administrative support to the study teams. This may include preparing meeting logistics, distributing agendas, and minutes for study team meeting, meetings with Academic Research Organizations (AROs), and meetings with CRO and Investigator Meetings.
  • Collect information and coordinate with DS Regulatory Operations to post trial information on required public forums ( Support Fair Market Value process in evaluating study budgets
  • Under supervision, review and document CRO-generated reports, such as site monitoring trip reports and protocol deviation reports and elevate issues to the attention of the supervisor.
  • Compile and maintain a monitoring review spreadsheet.
  • Ensure the Trial Master Files are inspection ready.
  • 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 your supervisor.
  • Create/maintain spreadsheets to track other items as needed, (e.g. Vendor invoices).
  • Analyze study site metrics reports to identify potential areas of concern and bring to supervisors attention.
  • Demonstrates knowledge of complex processes related to clinical studies, regulatory issues, CRO operations, and compliance practices 
  • Interacts appropriately with internal and external stakeholders (e.g., CROs and other team members).
  • Demonstrates foundational knowledge and application of complex compliance practices
  • Effectively manages information, data, related analyses, forms and reports  
  • Supports and effectively multi-tasks different and complex assignments and responsibilities.
  • Identifies and resolves problems when able to, escalates issues appropriately
  • Familiarity with medical terminology. Working skills in computer applications, such as Microsoft Word, Excel, PowerPoint, and Outlook. Basic oral and written communication skills.
  • A Bachelor’s degree (preferred in Life Sciences) with relevant clinical development experience is acceptable. 
  • Experience considered relevant includes 3 years of clinical or basic research in a Pharmaceutical company, a Medical device/Diagnostic company, Academic Research Organization (ARO) or Contract Research Organization (CRO). CRA experience is preferred. Time spent directly in a medical environment (e.g. as a Study Site Coordinator) is also considered 
Apply Online

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.

About Basking Ridge, NJ

Discover exciting job opportunities in the vibrant area surrounding Basking Ridge, New Jersey! Known for its picturesque landscapes, rich history, and thriving business community, Basking Ridge offers an unparalleled quality of life for professionals seeking growth and success. With easy access to NYC and iconic landmarks like the historic Jacobus Vanderveer House and the stunning Scherman Hoffman Wildlife Sanctuary, this charming region provides a perfect blend of career prospects and leisure pursuits. Indulge in locally sourced cuisine, catch a show at the elegant Ridge Performing Arts Center, or explore the natural beauty of Lord Stirling Park. Embrace the unique culture and endless possibilities that Basking Ridge has to offer as you explore our latest job listings and embark on a fulfilling career journey in this enchanting area.

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.