Clinical Research Associate

Highly Competitive Salary
  1. Permanent
  2. Clinical Research Associate (CRA), CRA Manager, Project/Study Manager (CSM/CPM)
  3. United States
Troy, USA
Posting date: 21 Oct 2020
CR.SR.33750

Proclinical is currently recruiting for a REMOTE Clinical Research Associate with a pharmaceutical company.

Job Responsibilities:

  • Compliance with applicable Corporate and Divisional policies and procedures, guidelines, standards and regulations.
  • Serving as primary contact for investigative site communication for each assigned site.
  • Collaborating with investigative sites to ensure completion and appropriate submission of all required clinical trial documents prior to site initiation.
  • Coordinating Institutional Review Board/ Ethics Committee (IRB/EC) approvals, as appropriate.
  • Training investigative site personnel to ensure compliance with study requirements and GCP, including, but not limited to the protocol, IRB/EC instructions, industry guidelines, international standards and local and national regulations.
  • Evaluating actual enrollment against assigned targets and working with assigned sites to meet, and whenever feasible, exceed enrollment targets.
  • Assessing case report forms (CRFs) for trends in safety, effectiveness, and adherence to protocol.
  • Performing on-site monitoring activities for assigned investigative sites in compliance with the approved monitoring plan and SOPs, with specific tasks to include:
    • Ensuring that final CRFs are accurate and complete by verifying against source documentation, as assigned.
    • Ensuring that all clinical trial documentation is properly reviewed, approved and filed within the Trial Master File and is accessible to investigative site personnel.
    • Ensuring investigational product and, as applicable clinical supplies accountability, handling and documentation are sufficient to continue, accurate, updated and appropriately delegated.
  • Preparing, submitting and filing of quality monitoring visit reports and associated follow-up letters in a timely manner.
  • Providing regular updates to the Investigator of assigned investigative sites, Study Manager and/or Lead CRA with respect to study conduct and compliance
  • Monitoring overall progress of clinical trials by regularly attending project and/or clinical trial team meetings, reviewing team communications and sharing pertinent information with assigned investigative sites, Study Managers, Lead CRAs, CRAs and other clinical trial team members.
  • Maintaining audit/inspection readiness at assigned sites throughout the conduct and upon closure of clinical trials at assigned investigative sites.
  • Supporting study payment activities or accruals, as assigned.
  • Ensuring all equipment/supplies provided to investigative sites is appropriately reported to Study Manager and/or Lead CRA.

Skills and Requirements:

  • 5+ years of independent field monitoring experience for clinical trials.
  • Risk Based and Remote Monitoring experience required.
  • Ophthalmic medical device industry experience required (e.g. intraocular lens (IOL) - Must have refractive surgical trial monitoring experience

If you are having difficulty in applying or if you have any questions, please contact Samantha Reader at 267-983-0134.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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