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Noven Pharmaceuticals · 4 weeks ago

Clinical Trial Associate

Jersey City, NJ

Full-time

Hybrid

Mid Level

3+ years exp

Noven Pharmaceuticals is a company focused on clinical research, and they are seeking a Clinical Trial Associate to support the coordination and management of clinical trials. The role involves critical evaluation of scientific documents, regulatory support, and effective communication across teams to ensure compliance with ethical and regulatory standards.

BiotechnologyHealth Care

Hiring Manager

Marilyn Reynaldo

Responsibilities

Works side-by-side with Project Manager(s) and Project Director(s) in providing assistance to efficiently and effectively oversee the clinical trial(s) progression including sponsor’s vendor/CRO oversight, compliance with systems use, ensures accuracy of data quality for subject safety

Liaises with CROs and other clinical vendors as directed to ensure deliverables are met and methods of communication are developed to facilitate efficient workflow

Liaises with Investigators and clinical site staff as appropriate to ensure optimal Sponsor-Site relationships as required

Translates complex scientific information into clear, actionable summaries for administrative and regulatory purposes

Participates in team meetings to discuss study progress, data trends, or emerging safety signals

Cooperates with CROs to ensure all Monitoring Reports represent the on-site quality and action items are followed through, protocol deviations are captured as necessary and classified correctly

Tracks milestones, site activations, and patient recruitment metrics with an understanding of underlying clinical study design

Provides administrative support and meeting coordination for clinical trials in scheduling, preparing presentations, agendas, action logs and minutes. This includes advisory committee meetings and investigator meeting support, and study training

Sets-up, updates and maintains clinical trial-related trackers such as regulatory documents, start-up progress, screening/enrollment, study invoices/payments, project budgets and others as necessary

Assists in site visits such as pre-qualification, initiation, monitoring, close out, audit, etc. and activities for single and/or multi-investigational sites in accordance with designated project assignments

Identifies and mitigates risks, ensures the trial progresses according to timeline and regulatory expectations

Reviews project documents like study protocols and amendments, informed consents, adverse event reporting, and ensures trial documentation is accurately maintained

Assists with the development and review of clinical trial documents (e.g., study related plans like protocols, amendments, ICFs, IRB reports, CSRs, IBs, SAPs, regulatory submissions)

Supports data integrity by cross-checking laboratory reports, pharmacokinetic/pharmacodynamic data, and adverse event summaries

Verifies and reviews collected trial data to confirm validity and scientific reliability, assists in reconciliation

Performs quality reviews of trials master files to ensure completeness and audit-readiness

When on clinical site, reviews investigator’s study file to ensure that all documents are ready for an audit and/or site inspection and discusses pertinent study materials retention and publication policy

Qualification

Clinical trial operationsICH-GCP guidelinesFDA regulatory requirementsClinical research experienceMS Office SuiteAnalytical abilityWritten communicationVerbal communicationTeam collaboration

Required

Bachelor's degree in Science/Health related field (i.e. Nursing, Medical Terminology, Biology, Pharmacy or Biochemistry) or equivalent education, or experience

Three to five years of professional experience in clinical research or the pharmaceutical industry

Good written and verbal communication skills, including public speaking; ability to establish and maintain internal and external working relationships

Ability to work independently with limited supervision and within a team environment

Computer literate at the intermediate level of MS Office Suite application software

Knowledge of clinical trial operations, ICH-GCP guidelines, FDA regulatory requirements (CFRs and GCPs)

Must be able to recognize clinical values and abstract data from source documents and possess analytical ability to identify data or patient safety issues

Must have a thorough understanding of clinical trial protocols, data collection requirements, and methodologies