Clinical Research Associate

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

The Clinical Research Associate will lead clinical studies and/or parts of studies. The associate will be responsible for leading clinical study activities and procedures. Duties also include execution of experimental protocols and specimen processing.

Essential Duties and Responsibilities

• Lead clinical research activities and study management.
• Liaison with Clinical Services, Medical Director, Veterinary Director, and Clinical Consultants to lead special test requests and results delivery.
• Responsible for process of sample de-identification, coding, blinding and randomization for FDA and IRB compliance in clinical research
• Lead human and/or veterinary clinical trials and other studies, as applicable, with collaborating institutions and prepare associated documentation.
• Specimen processing, storing, shipping and sample set preparation/documentation
• Perform monitoring activities per the monitoring plan (e.g. verification of source documents and eCRF/CRFs, site communications, follow up on data anomalies, etc.)
• Review accuracy and completeness of site records (i.e., essential documents, query resolution, and other data collection tools).
• Lead budget and contract negotiations with clinical trial sites.
• When applicable, training of additional personnel on clinical trial activities.
• Ensure work is aligned with all relevant quality requirements.
• Participates in and adheres to the Quality Program
• Adhere to safety SOPs and report potential safety hazards.
• Must be able to work productively and independently in an interdisciplinary team environment.
• Other duties as assigned

Education

• B.A. or B.S. in Biology, Microbiology, Biochemistry or other Scientific Field or pertinent experience preferred.
• Minimum of 4 years pertinent industry experience preferred.

Skills, Specialized Knowledge and Abilities

• Must be able to work productively and independently in an interdisciplinary team environment.
• In-depth knowledge of research principles and Good Clinical Practice (GCP).
• The candidate should have experience with protocol development and the ability to grasp in-depth scientific study design and regulatory principles related to the products being evaluated in the course of the clinical research.
• In-depth knowledge in the areas of microbiology, immunology or molecular biology and biochemistry preferred.
• Strong skills in database management.
• Strong attention to detail and problem solving abilities.
• Must possess exceptional communication (written and verbal), interpersonal and problem solving skills.
• Highly motivated, readily adapts to changing priorities, effectively manages own time to ensure tasks, multiple projects are completed on time.