Clinical Research Associate (Maryland / Pennsylvania)


Category: CRA
Job #: 10608
Location: Maryland / Pennsylvania
Job Type: 1099
Rate / Salary Range: $75-90/hour

One of our Sponsor Partners is looking for a contract CRA with a medical background and 3-5 years experience as a Sr CRA.  This monitor should have at least 1-year Ophthalmology experience, and at least 25% utilization to monitor an Ophthalmology study. This device study will be for the treatment of patients with dry AMD.  Qualified candidates will need to be located in the MD/PA area and willing to travel when sites open.

Job Responsibilities:
  • Act as the "Site Manager" ensuring relationship with site(s) are positive, issues are resolved quickly, and communications are strong across all verticals.
  • Assist with the development of study manuals, CRFs, monitoring standards, site study tools and other study materials as required.
  • Develop and implement site recruitment, selection and initiation plan.
  • Manage and drive patient recruitment and enrollment tracking.
  • Provide training to sites on the study protocol, study conduct, CRF completion and data management expectations.
  • Ensure essential document collection for completeness per regulatory requirements.
  • Serve as a liaison with Investigators, Institutions and sites to provide support during the conduct of the clinical trial and serve as a resource for protocol and procedures.
  • Demonstrate knowledge of on-site monitoring to ensure compliance with GCPs, study protocols, and SOPs.
    Manage one or multiple studies.
  • Monitor product supplies/accountability including proper storage, dispensation, and disposal.
  • Manage study completion activities including CRF collection, query resolution, record archiving and site closeout activities.
  • Review in-house data and study tables.
  • Mentor, coach and provide guidance to clinical staff as appropriate.
  • Supervise and train other employees as appropriate.
Job Qualifications:
  • Must have at least 1 year's experience monitoring Ophthalmology studies
  • Must have at least 25% availability
  • Must be willing to travel when sites are opened (currently remote monitoring due to Covid-19
  • Must be located in the MD/PA area
  • A medical background is a huge plus
  • Dry AMD experience is a plus
  • A bachelor's degree is strongly preferred

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