Catalyst Clinical Research is hiring a
Safety Specialist

Summary

Join our team as a Safety Specialist and play a key role in coordinating and managing contracted safety responsibilities, developing internal processes, and ensuring compliance with established procedures.

Requirements

• Education: Healthcare or life science degree; with optional licensure as a health care professional (MD, RN, RRT, MLT)
• Experience: 2 years of clinical research experience with a CRO or pharmaceutical company is preferred
• Knowledge of the drug development process and FDA regulations, ICH GCP guidelines, and their application to clinical trials
• Knowledge of global regulatory reporting requirements for safety updates, Adverse Event reporting and other requirements for Medical and Safety submissions
• Ability and willingness to travel to investigator meetings, investigative sites and bid defense meetings, etc., up to 25%
• Proficient with Microsoft Office Suite
• Excellent written and oral communication skills
• Excellent presentation 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
• Proven ability to handle multiple projects and meet deadlines
• Strong interpersonal skills
• Ability to deal effectively with a diversity of individuals at all organizational levels
• Commitment to excellence and high standards
• Creative, flexible, and innovative team player
• Ability to work independently and as a member of various teams and committees
• Good judgement with the ability to make timely and sound decisions

Responsibilities

• Assist with the implementation of appropriate reporting processes and coordinate with staff, third party and/or consultants to complete reports within required regulatory timeframes
• Assist in the onboarding and training of Pharmacovigilance (PV) Safety Staff
• Support Project Management team representatives with PV input for meetings and financial matters
• Responsible for the completion of Quality Events (QE) and/or CAPA in response to internally identified system/process weaknesses and/or customer complaints related to PV
• Accountable for providing input on the financial management of the medical and safety portion of study budgets
• Support implementation activities to configure the Safety Database, CTMS, EDC and eTMF systems and to draft SOPs describing core processes