Lead Clinical Research Associate (NYC Area)


Category: CRA
Job #: 10619
Location: New York City area
Job Type: Permanent
Rate / Salary Range: $110-$130k

One of our sponsor clients is looking for a Lead CRA in the New York City area. This is a permanent position with a biopharmaceutical company dedicated to creating solutions that treat cancer and diseases. Candidates would be expected to work in a New York City office 3 days per week and travel as needed (estimated to be 25%).

Job Responsibilities:
  • Manage one or multiple studies
  • Monitor product supplies/accountability
  • 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
  • Effectively review trip reports as per annotated report, protocol, Sponsor SOPs and monitoring plan, ensuring errors are minimized, reports are consistent across visits and sites and adhere to the highest standards of quality
  • To observe and escalate safety trends in patients as identified in trip reports
  • To follow up on action items and protocol deviations and to be a liaison between CRA, CTM and PM for timely resolution of issues
  • Track processing time throughout review cycle, ensuring turnaround time of the trip reports adhere to Sponsor SOPs
  • Regular oversight of tracking systems to ensure key metrics, e.g. MVR and FUL timelines, action Items and other quality metrics are being met and followed
  • Compile information and provides status updates to monitoring management and to monitoring staff, as requested
  • Where required, attend project meetings and actively provide suggestions for improvement of quality of reports, provide feedback for timely and appropriate resolution of action items and report trends
  • Liaise with CTM to communicate any trends, outstanding issues, safety concerns or any other activity or lack thereof which may jeopardize the clinical trial delivery or patient safety
  • Ensure all necessary trainings, required to improve job performance and knowledge, are completed in a timely manner
  • Contribute towards quality improvement and risk management plans to minimize impact on project objectives and deliverables, and patient safety and show consistent improvement in metrics
  • May be involved in the start-up of new studies by providing input on the visit report template
  • Provide training to other CRAs on the study protocol, study conduct, CRF completion and data management expectations
  • Ensure essential document collection for completeness per regulatory requirements
  • Demonstrate knowledge of on-site monitoring to ensure compliance with GCPs, study protocols, and SOPs
Job Qualifications:
  • Must be located within driving distance of New York City, as you will need to work in the office 3 days per week
  • Travel is estimated to be at 25%
  • Minimum 6 years recent experience as a monitor or manager for a sponsor or CRO
  • Must be proficient in IxRS, CTMS, and EDC systems
  • Competitive salary

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