Clinical Research Associate

Cleerly, Inc - New York, NY

Full-time

Aboutthe Role

We are seeking a ResearchAssociate with pharma industry and/or clinical experience to help shape anddeliver on the future direction of our product. We are looking for a highlymotivated individual to join our growing start-up team and work from our NewYork office.

MajorResponsibilities

§ Support projects throughout the entire projectlife-cycle, from developing the scope, schedule and project requirements throughto delivering the project on time and on budget

§ In depth knowledge of ICH/GCP, regulatoryguidelines/directives, and drug development and clinical research processes

§ Time management skills – ability toeffectively prioritize

§ Run effective meetings with clear agendas,goals and outcomes

§ Create study documents including but notlimited to: Informed Consent, Case Report Forms, letters to the Clinical Sitesand Principal Investigators

§ Proactively identify obstacles, risks and gapsin the project plan and process; suggest solutions on how to resolve them

§ Assess existing processes and identifyopportunities for improvements to promote collaboration and efficientimplementation across the different functional teams and with external vendors

§ Support the strategic and tactical businessplanning annual process, implementation, and monitoring across the business

§ Support cross functional projects

§ Manage and initiate execution on all phases ofassigned initiatives, working with appropriate team members and differentfunctional areas as necessary

§ Manage all communications with Clinical Sites

§ Effectively collaborate with team members onmethodologies best practices

§ Study Tools including electronic system skills– CTMS / EDC/eTMF, etc

Job Type: Full-time

Experience:

  • clinical study experience at a CRO or Pharma/Biot: 3 years (Required)
  • Project Management in clinical trials: 3 years (Preferred)

Education:

  • Bachelor's (Required)

Work authorization:

  • United States (Preferred)

Additional Compensation:

  • Other forms

Work Location:

  • One location

Benefits:

  • Health insurance
  • Dental insurance
  • Vision insurance
  • Paid time off

Schedule:

  • Monday to Friday