Senior Clinical Research Associate IVD

Kelly Services - Washington, DC

Full-time - Senior

Hybrid - Washington, DC

Administrative and Support Services

About the position

The Senior Clinical Research Associate (Sr. CRA) is responsible for executing clinical trials and supporting various operational activities related to clinical evaluations for in vitro diagnostic products. This role involves site identification, monitoring, and ensuring compliance with Good Clinical Practice (GCP) and study protocols. The position is remote and part of the Clinical Affairs department, aimed at advancing scientific discoveries in the biotech sector.

Responsibilities

• Execute all activities related to a clinical study, including clinical site selection, contract negotiation, and study initiation visits.
• Conduct interim monitoring visits and study close-out visits.
• Perform data monitoring activities, including on-site and remote audits of study data for accuracy, integrity, and completeness.
• Identify and suggest resolutions for problems at sites related to GCP or protocol compliance.
• Prepare study documents for review by project leads, including training materials and case report forms.
• Maintain familiarity with GCP and assigned protocols.

Requirements

• Bachelor's degree in a scientific discipline (Clinical Sciences, Health/Life Sciences, Biology, Biochemistry, or Human Physiology).
• Minimum of 5 years of experience monitoring In Vitro Diagnostic (IVD) products or medical devices.
• Experience working directly for a sponsor company or through a Full Service Provider (FSP) alignment.
• Experience in all aspects of clinical trials, including site selection, study visits, and drafting study-specific documents.
• Current knowledge of clinical trial regulatory requirements and guidelines (GCP, ICH, FDA).
• Excellent oral and written communication skills.
• Ability to develop strong rapport with investigators and site staff.
• Experience working with ex-US sites.

Nice-to-haves

• Experience with in vitro diagnostic (IVD) products in molecular diagnostics or immunodiagnostics, especially in oncology or infectious disease.
• Experience with laboratory automation and biological databases.
• CCRA certification.

Benefits

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