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Lead Clinical Research Specialist
2 months ago
The Research & Development Institute, Inc. (RDI) is a cutting-edge Contract Research Organization (CRO) dedicated to assisting In Vitro Diagnostic manufacturers in navigating the complexities of FDA clearance by facilitating access to essential blood samples through collaborations with healthcare providers and laboratories.
Following a significant investment in 2021, RDI has evolved from a founder-led initiative into a premier diagnostic CRO, equipped with scientific experts and a CLIA-certified laboratory, enabling us to undertake larger and more lucrative projects.
We are currently in search of a Senior Clinical Research Associate to oversee the timely execution of our clinical trials, ensuring adherence to protocols while maintaining clear communication with our clients and clinical sites throughout the study process.
This role offers a long-term career trajectory with ample opportunities for advancement as our organization expands across the nation. Additionally, RDI is committed to supporting the selected candidate in obtaining SOCRA CRA certification through training and resources.
Key Responsibilities
- Oversee diagnostic clinical studies, which are generally less complex than pharmaceutical trials.
- Develop and manage study protocols, case report forms, budget negotiations, and regulatory documentation.
- Assist clinical sites with Institutional Review Board (IRB) submissions and related documentation as required.
- Maintain and update Diagnostica, our remote clinical trial management system.
- Monitor clinical studies by creating monitoring plans, identifying and resolving queries, and ensuring compliance of site regulatory binders.
- Foster and manage relationships with clinical sites, assisting with study initiation, addressing inquiries during the study, and ensuring timely payments and closeout procedures.
Qualifications
- A minimum of 2 years of experience in clinical research, either as a high-performing research coordinator or Clinical Research Associate.
- Familiarity with established good clinical practice (GCP) guidelines and procedures.
- Exceptional organizational, time management, budget oversight, and problem-solving abilities.
- A proactive approach and adaptability in a dynamic, fast-paced small company environment.