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MiraVista Diagnostics seeks a Clinical Research Associate to lead clinical studies and manage research activities from initiation through completion. This role bridges internal teams (Clinical Services, Medical Director, Veterinary Director, Clinical Consultants) and external collaborating institutions to execute clinical trials and special test requests.
Key responsibilities include:
- Leading clinical research activities and overall study management
- Managing sample de-identification, coding, blinding, and randomization to ensure FDA and IRB compliance
- Executing experimental protocols and specimen processing, including storage, shipping, and documentation
- Conducting monitoring activities per established monitoring plans (source document verification, eCRF/CRF review, site communications, data anomaly follow-up)
- Reviewing accuracy and completeness of site records, essential documents, and query resolution
- Leading budget and contract negotiations with clinical trial sites
- Training personnel on clinical trial activities as needed
- Ensuring alignment with quality requirements and adherence to safety SOPs
- Reporting potential safety hazards and participating in the Quality Program
- Working independently and collaboratively within an interdisciplinary team environment
The role requires strong organizational skills, attention to detail, and the ability to manage multiple projects simultaneously while adapting to changing priorities.
Qualifications:
- B.A. or B.S. in Biology, Microbiology, Biochemistry, or other scientific field (or equivalent pertinent experience)
- Minimum 4 years of pertinent industry experience preferred
- SOCRA CCRP certification preferred
- In-depth knowledge of research principles and Good Clinical Practice (GCP)
- Experience with protocol development and scientific study design
- In-depth knowledge in microbiology, immunology, molecular biology, or biochemistry preferred
- Strong database management skills
- Exceptional written and verbal communication, interpersonal, and problem-solving abilities
- Proficiency with Microsoft Office products
- Ability to work productively and independently in an interdisciplinary team environment
