Sponsor Ophthalmology Contract CRA in Northeast US (Boston preferred)

Category: CRA
Job #: 10912
Utilization: 40%-60%
Location: Boston, MA
Job Type: 1099
Therapeutics: Ophthalmology

We’re partnering with a wonderful small Sponsor seeking a Contract Clinical Research Associate (CRA) based in the Northeast, who is close to a major airport with direct flights to Boston, Phoenix, and Los Angeles. This role offers the opportunity to work closely with a collaborative team supporting sites in Boston, Los Angeles, and Phoenix. The ideal candidate will bring five years of recent experience as a CRA with a CRO or Sponsor, at least one year of ophthalmology monitoring experience, and the flexibility to support additional project needs within a smaller sponsor environment, including assisting with TMF cleanup and cross-functional study activities.

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:
  • Senior CRAs only - must have at least 5 years' experience as a fully dedicated, home-based, Clinical Research Associate/Site Manager/Field Monitor.
    • This experience must have been gained by working directly for a CRO or Pharma.
    • Only recent monitoring experience will be accepted (i.e., must have monitored within the last 2 years).
  • Must be located in the Northeast US area and close to a major airport with direct flights to monitor sites in Boston, Los Angeles, and Phoenix and have at least 40% utilization available (additional utilization available as they need a CRA with the flexibility to support additional project needs within a smaller sponsor environment, including assisting with TMF cleanup and cross-functional study activities)..
  • At least 1 year experience monitoring Ophthalmology studies.
  • Phase II experience is also required, in any therapeutic.
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