Contract Clinical Research Associate

About the position

The Clinical Research Associate (CRA) position at Kelly Services is a contract role focused on managing and monitoring diagnostic clinical studies. This remote position offers flexibility in hours and requires a commitment to ensure clinical trials are completed on time and according to protocol. The CRA will work closely with clinical sites and clients, ensuring compliance and effective communication throughout the study process.

Responsibilities

• Manage diagnostic clinical studies
• Develop and manage the protocol, case report form, budget/contract negotiation and regulatory document management
• Assist clinical sites with IRB submission/documentation, as needed
• Setup and keep Diagnostica, their own remote clinical trial management system, up to date
• Monitor clinical studies
• Develop monitoring plans, identify issues, and resolve queries, ensure site regulatory binders are compliant
• Manage site relationships by helping with study startup, answer questions during the study, ensure timely payments and close out activities

Requirements

• A minimum of 2 years clinical research monitoring experience with a CRO, biotech, or pharmaceutical company required
• Diagnostic clinical study experience or lab diagnostic experience (IVD monitoring experience requested)
• Knowledge of accepted good clinical research practice (GCP) and procedures
• Excellent organizational, time management, budget management, and problem-solving skills
• Comfortable in a fast-paced small company environment
• Must have home office set up and ability to travel nationwide up to average of 50% at times

Nice-to-haves

• SOCRA CRA certification preferred

Benefits

• Voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability
• Retirement savings plan
• Service bonus and holiday pay plans (earn up to eight paid holidays per benefit year)
• Transit spending account
• Paid sick leave under the applicable state or local plan