Clinical Trials Lead: Research & Compliance

MiraVista Diagnostics; Indianapolis (IN); On-site; USD 70,000 - 100,000; Full time

Job summary

MiraVista Diagnostics seeks a Clinical Research Associate to lead clinical studies and oversee study activities, data integrity, and regulatory compliance across projects. You will coordinate with clinical services, medical and veterinary directors, and consultants to drive test requests and results delivery.

Responsibilities include protocol execution, sample handling, monitoring, site communications, and documentation preparation, ensuring quality and safety standards are met across studies.

Qualifications

• Knowledge of Good Clinical Practice (GCP) and clinical research principles.
• Experience with protocol development and understanding of study design and regulatory aspects.
• Strong data management and documentation skills.
• Ability to manage multiple projects with attention to detail.

Responsibilities

• Lead clinical research activities and study management.
• Liaison with Clinical Services, Medical Director, Veterinary Director, and Clinical Consultants for test requests and results delivery.
• Ensure FDA/IRB compliance including sample de-identification, coding, blinding and randomization.
• Lead human and/or veterinary clinical trials with collaborating institutions and prepare documentation.
• Process specimens: storage, shipping, and documentation.

Skills

GCP knowledge

Clinical trial coordination

Regulatory principles

Microbiology/Immunology/Biochemistry

Database management

Communication skills

Time management

Education

B.A. or B.S. in Biology/Science

4 years industry experience

Job description

MiraVista Diagnostics seeks a Clinical Research Associate to lead clinical studies and oversee study activities, data integrity, and regulatory compliance across projects. You will coordinate with clinical services, medical and veterinary directors, and consultants to drive test requests and results delivery.

Responsibilities include protocol execution, sample handling, monitoring, site communications, and documentation preparation, ensuring quality and safety standards are met across studies.