Research Assistant

Why Join Us?

• Be part of a practice at the forefront of cutting-edge cancer care and advanced treatments
• Access opportunities for professional growth and continuing education.
• Work alongside a collaborative and compassionate team of experts dedicated to making a difference.
• Enjoy the convenience of multiple locations throughout the Capital Region.
• Contribute to groundbreaking clinical trials that shape the future of oncology care.
  
  

Discover your career potential with a practice dedicated to excellence and innovation.

Job Description

Pay Range: $20 - $24/hr

Scope: Under minimal supervision is responsible for the research regulatory and administrative activities of clinical trials for the practice. Plays an integral role in the regulatory/compliance process of all clinical research conducted to include site qualification, and management of the study regulatory documents throughout the site’s participation. Collaborates with research staff and management on process improvement and QA initiatives. May train other employees on regulatory process. Ensures site research quality by practicing in compliance with Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations through OSHA, CDC and HIPAA.

Key Responsibilities

• Support site qualification and startup preparation
• Manage regulatory documentation
• Coordinate training for protocol updates and amendments
• Maintain SOP, GCP, and IATA training statuses
• Collect and maintain critical regulatory documents
• Serve as liaison with CROs and sponsors
• Coordinate all monitoring and audit visits
• Prepare regulatory packets (FDA 1572, FDQs, etc.)
• Submit to local and central IRBs
• Report on SAEs to sponsors/FDA/IRB
• Facilitate amendment training and documentation
• Support annual IRB continuing review
• Assist with finance packet documentation
• Manage lab kits, stockroom supplies, and IP temperature logs
• Support specimen management
• Perform data entry into vendor eDC systems, when needed
  
  

Minimum Job Qualifications

• High School Diploma required; Associate degree in a clinical or scientific related discipline preferred
• Minimum 3 years of relevant experience required (research, regulatory, or oncology)
• Ability to navigate multiple electronic platforms
  
  

Working Conditions

Environment (Office, warehouse, etc.) –

• Traditional outpatient clinic/office environment.
• The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Exposure to communicable diseases, toxic substances, ionizing radiation, medical preparations and other conditions common to an oncology/hematology clinic environment.
  
  

Physical Requirements (Lifting, standing, etc.) –

• Large percent of time performing computer based work is required.
  
  

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Requires standing and walking for extensive periods of time. Occasionally lifts and carries items weighing up to 40 lbs. Requires corrected vision and hearing to normal range.