Clinical Research Specialist II – Neurosurgery

This is a fully remote position, open to applicants in United States.

📋 Description

• Engage in the design and execution of clinical research initiatives.

• Establish research infrastructure and oversee designated projects.

• Manage institutional or departmental research endeavors.

• Update leadership on project status and areas for enhancement.

• Assist in the development of investigator-initiated protocols, which includes protocol drafting, case report form creation, budget formulation, and coordination with departmental research committees.

• Offer expertise on project planning, logistics, and execution.

• Implement and manage research quality assurance or clinical trial recruitment programs across the department.

• Ensure adherence to federal and local regulations, including those set by the FDA and local Institutional Review Boards.

• Uphold research practices in line with Good Clinical Practice (GCP) standards.

• Safeguard patient confidentiality in compliance with HIPAA regulations and relevant laws.

• Create scientific documents for abstracts, publications, presentations, funding applications, and study protocols.

• Act as an internal consultant for specific departmental functions.

⛳️ Requirements

• A Bachelor's degree is mandatory.

• A minimum of five (5) years of demonstrated experience in the relevant research field.

• Familiarity with Good Clinical Practice (GCP) guidelines.

• Understanding of FDA and Institutional Review Board compliance standards.

• Awareness of HIPAA regulations and applicable laws.

🏝️ Benefits

• Eligibility for benefits within this fixed-term part-time role.

• Involvement in necessary training and educational programs.