Safety Operations Specialist

6 days ago


Raleigh, North Carolina, United States Catalyst Clinical Research, LLC Full time
Job Description: Safety Operations Specialist

Catalyst Clinical Research, LLC is seeking a skilled Safety Operations Specialist to join our team.

Estimated Salary: $75,000 - $95,000 per year

About the Role

The Safety Operations Specialist will play a key role in coordinating and managing contracted safety responsibilities for one or more programs, including staffing, training, and procedural compliance.

This individual will work closely with senior management to develop consistent internal processes and ensure compliance with established procedures.

The Safety Operations Specialist will also liaise with the Project Manager and clients to ensure optimal performance and utilization of the safety project team.

Key Responsibilities
  1. Coordinate with staff, third party, and/or consultants to implement reporting processes and complete reports within required regulatory timeframes.
  2. Support Project Management team representatives with PV input for meetings and financial matters.
  3. Collaborate with the Director of Safety to assist with revenue recognition and profitability review processes.
  4. Responsible for completing Quality Events (QE) and/or CAPA in response to internally identified system/process weaknesses and/or customer complaints related to PV.
  5. Provide input on the financial management of the medical and safety portion of study budgets.
  6. Support implementation activities to configure the Safety Database, CTMS, EDC, and eTMF systems and to draft SOPs describing core processes.
Requirements
  • Educational background in Healthcare or life science degree; with optional licensure as a health care professional (MD, RN, RRT, MLT).
  • 2 years of clinical research experience with a CRO or pharmaceutical company is preferred, however, educational background and experience will be taken into consideration for new graduates of an accredited college program and healthcare professionals with experience in clinical settings or clinical research.
  • Knowledge of the drug development process and FDA regulations, ICH GCP guidelines, and their application to clinical trials.
  • Ability and willingness to travel up to 25%.
  • Proficient with Microsoft Office Suite.
  • Excellent written and oral communication skills.
  • Strong organizational, problem-solving, and analytical skills.
  • Ability to manage priorities and workflow.
  • Versatility, flexibility, and a willingness to work within constantly changing priorities.


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