Senior Clinical Research Associate — Hybrid/Remote Lead

Katalyst-Healthcares-; United States; Hybrid; USD 95,000 - 130,000; Full time

Job summary

JobDiva, Inc. is seeking a Senior Clinical Research Associate (Sr. CRA) to independently manage clinical aspects of studies, collaborating with cross-functional teams, vendors, sites, and CROs to ensure adherence to GCPs and study protocols. The role supports timelines, budgets, and TMF maintenance while serving as a liaison across functions.

The Sr. CRA will oversee site management, protocol amendments, vendor oversight, and staffing needs, with a hybrid work setup including remote options.

Qualifications

• Bachelor's degree in a scientific discipline.
• At least 4 years of clinical trial management experience.
• Strong understanding of drug development, ICH guidelines, and SOPs.
• Excellent communication and organizational skills.
• Ability to prioritize tasks and meet deadlines.

Responsibilities

• Manage clinical protocols per SOPs, ICH/GCP, and program goals.
• Support Study Lead in start-up, enrollment, maintenance, and closeout.
• Participate in protocol development and amendments with medical writing.
• Oversee vendor activities (IRT, eCOA, cardiac safety) to ensure data quality.
• Manage selected sites and CRO monitoring activities; negotiate contracts and budgets.
• Assist with IP shipment and reconciliation at study/site level.
• Coordinate meeting agendas/minutes with CTA.
• Contribute to study design from operations perspective.
• Review CRO/vendor RFPs and participate in vendor selection.
• Assist in timelines and budgets to meet deliverables.
• Develop essential trial documents and TMF maintenance.
• Ensure trials are on time and on budget.

Skills

Clinical trial management

ICH/GCP knowledge

SOPs & study protocols

Team collaboration

Vendor coordination

Regulatory compliance

Communication skills

Education

Bachelor's degree in a scientific discipline

Tools

Microsoft Office

Job description

JobDiva, Inc. is seeking a Senior Clinical Research Associate (Sr. CRA) to independently manage clinical aspects of studies, collaborating with cross-functional teams, vendors, sites, and CROs to ensure adherence to GCPs and study protocols. The role supports timelines, budgets, and TMF maintenance while serving as a liaison across functions.

The Sr. CRA will oversee site management, protocol amendments, vendor oversight, and staffing needs, with a hybrid work setup including remote options.