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Ophthalmology Clinical Research Associate

Company

SRG

Address United States
Employment type FULL_TIME
Salary
Category Medical Equipment Manufacturing,Pharmaceutical Manufacturing
Expires 2023-09-27
Posted at 8 months ago
Job Description

Job Title: Ophthalmology Clinical Research Associate

Location: 100% Remote

Job Type: Permanent Full-Time


** Candidates must have experience in Ophthalmology Clinical Research trials to be considered!


We are searching for a permanent full-time Ophthalmology Clinical Research Associate who will be responsible for the day-to-day activities related to the initiation and implementation of clinical investigations. The successful candidate will manage multiple clinical sites to assure compliance with GCP, the investigational plan and relevant regulations, and up to 70% travel will be required.


WHAT YOU HAVE:

  • Bachelor’s degree in biological/health sciences
  • Experience in glaucoma devices is strongly preferred.
  • Knowledge of medical and ophthalmology terminology
  • Minimum of four (4) years of experience in clinical research specifically in Ophthalmology surgical medical devices.


Responsibilities include, but are not limited to:

  • Remotely monitor data and support clinical sites for protocol compliance and recruitment activities
  • Participate in database lock activities, annual/final report creation, and preparation of regulatory submissions
  • Complete site visits to verify case report forms for accuracy and completeness, ensure regulatory binder completeness and liaising with the study site
  • Oversee clinical trial start-up activities including investigator identification, shipment of clinical study supplies and investigational product, and collection of in-house clinical study files
  • Coordinate with investigative sites for IRB approval and ongoing clinical trial execution activities, including site visits, maintain communication with sites for support on regulatory documents and vendor needs, oversee device accountability, and ensure adequate supply at clinical sites, support EDC activities, and development of study tools and aids
  • Manage clinical trial close-out activities, including return of investigational product, final reconciliation of all required documentation, and EDC close-out


** Only candidates selected to be moved forward in the recruitment process will be contacted by SRG's Recruitment Team to schedule a conversation.


SRG is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.