Clinical Research Associate

Role Description

The Clinical Research Associate plays a vital role in the Clinical Operations team. Through responsibilities like monitoring studies, reviewing data, and engaging with sites, the CRA will ensure the success of clinical trial operations and management.

• Monitoring clinical studies of investigational and approved products that have been determined to satisfy a medical need and/or offer a commercial benefit. This may include the following site visits: qualification, initiation, interim, and close out

• Managing and training of site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion

• Managing, preparing, sending, tracking, and returning investigational supplies at individual sites

• Monitoring and documenting investigational product dispensing, inventory, and reconciliation

• Monitoring and documenting laboratory sample storage and shipment

Monitoring trial by reviewing and reporting on the following: site enrollment and termination updates, monitoring visits, protocol deviations/exceptions, serious adverse events, and laboratory abnormalities

• Reviewing source data and case report forms for accuracy, completeness, and integrity of the data, and identifying and resolving ongoing data issues

• Reviewing data queries and listings, and working with the study centers to resolve data discrepancies

• Reviewing regulatory documentation for accuracy and completeness, and supporting study centers with regulatory issues

• Maintaining complete and accurate study files and reviewing files to ensure all appropriate documentation is present

• Maintaining consistent and timely contact with the study centers, investigators, coordinators, client personnel, and other individuals involved in clinical trials.

• Following Good Documentation Practices, completing Visit Reports and site correspondence in accordance with SOPs

• No travel restrictions (i.e. willing to go anywhere in the US)

Skills & Requirements

• Minimum two years' ophthalmology monitoring experience- preferred specific indications would be Ph IIa dystrophy and Ph III nAMD (gene therapy); recent ophthalmology experience (cannot have been from 5+ years ago)

• Solid tenures throughout their career- if they do not have strong tenure then we will need explain why candidate has jumped around and the reasons need to be valid

• Bachelors Degree

• CRO or Pharma experience