Clinical Study Associate

Edison, NJ

Contract

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OVERVIEW

We are currently searching for a skilled professional to join a well-known client’s team as Clinical Study Associate in Edison, New Jersey.  Clinical Study Associate role will assist in planning and execution of clinical studies, under the close supervision of a Senior Manager (or above) 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 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 client Quality Oversight measures. 

RESPONSIBILITIES

  • Support and assist the transmittal of trial and site level document to the client 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
  • 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 client Regulatory Operations to post trial information on required public forums 
  • Works with Insurance Brokers to obtain study site Insurance
  • Under the guidance of the supervisor, analyze site metrics reports to identify potential areas of concern and bring to supervisors attention
  • 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)

EXPERIENCE

  • Experience considered relevant includes clinical or basic research in a Pharmaceutical company, a Medical device/Diagnostic company, Academic Research Organization (ARO), and Contract Research Organization (CRO)
  • Time spent directly in a medical environment (e.g. as a Study Site Coordinator) is also considered relevant
  • Develops basic working knowledge of processes related to clinical studies, regulatory issues, assigned CRO operations, and compliance practices
  • Builds ability to interact appropriately with internal and external stakeholders (e.g., CROs and other team members)
  • Builds foundational knowledge and application of compliance practices
  • Builds understanding in how to assist in managing information, data, related analyses, forms and reports
  • Develops ability to support and effectively multi-tasks different assignments and responsibilities
  • Builds ability to identify and resolve problems
  • Working skills in computer applications, such as Microsoft Word, Excel, PowerPoint, and Outlook
  • Basic oral and written communication skills

EDUCATION

An Associate Degree or Associate Nursing Degree/Diploma with relevant clinical development experience is acceptable
Bachelor’s degree or higher preferred

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.

Regarding Your Application

Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

847-267-1176