Clinic Research Associate – New Jersey Office or Virtual

Clinic Research Associate – New Jersey Office or Virtual

We are seeking an experienced project based Clinical Research Associate (CRA) to join a Clinical R& D team.

The CRA coordinates and conducts GCP and study protocol training at study sites and assures training is documented, and builds rapport with study site staff to assure compliance with the protocol, applicable regulatory and guidance documents, SOPs, and all study activities. The incumbent will assist in reviewing the study records and all study notebooks to ensure contents are current and complete; assist in providing tracking and Quality Control (QC) of data as required and assists with responses to QA audits; and evaluate Investigators and assists with selection of appropriate sites to conduct clinical studies. The CRA also collaborates with the study Project Manager to assure study sites selected meet the needs of the study protocol; monitors assigned study sites through review of electronic data capture (EDC) systems, faxed, emailed, and paper documentation; and services as the liaison between the company and study site personal. The incumbent is primarily responsible for the creation, development, and execution of documentation for the study, including marketing materials, social media campaigns, and required written communications. Furthermore, the CRA tracks adverse events encountered in clinical studies and ensures all serious AEs and non-serious AEs are documented and communicated appropriately to the Project Manager and Sponsor; learns to assist with facilitates clarifications, corrections, and data query resolution with study sites or data management personnel; and builds relationships with key individuals and contributors in the organization and beyond.

Qualifications

  • Minimum of 2 years’ experience in a scientific discipline and/or veterinary/veterinary technician experience
  • Experience in Good Clinical Practice (GCP) data management, quality control, and/or quality assurance preferred
  • Collaborative working style. Lead and motivate people through influence across all levels and functions of the organization
  • Ability to look for creative solutions to resolve complex issues
  • Strong technical writing ability
  • Results oriented and driven
  • Strong communication and listening skills
  • Well organized
  • Willingness to travel, expected to travel nationally up to 40 to 60%

Compensation is commensurate with experience.

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