Senior Clinical Research Associate Manager
1 week ago
R&D Institute, Inc. is a pioneering tech-enabled Contract Research Organization (CRO) dedicated to helping In Vitro Diagnostic manufacturers overcome FDA clearance hurdles by sourcing essential blood samples through physicians and labs.
Fueled by a significant investment in 2021, RDI has transformed from a founder-led business into a world-class diagnostic CRO, boasting scientific experts and a CLIA-certified lab that enable the management of larger, more profitable projects.
We are seeking an experienced Senior Clinical Research Associate to ensure seamless completion of our clinical trials, aligning with client and site expectations throughout the process.
This long-term career opportunity offers substantial room for growth as our company expands nationwide. Additionally, RDI will provide support and resources for the successful candidate to obtain SOCRA CRA certification.
Responsibilities- Manage diagnostic clinical studies, utilizing expertise to drive efficient project delivery.
- Develop and oversee protocol development, case report form creation, budget/contract negotiation, and regulatory document management.
- Assist clinical sites with IRB submission/documentation, ensuring compliance and accuracy.
- Maintain and update Diagnostica, our remote clinical trial management system, to ensure seamless data tracking and analysis.
- Monitor clinical studies, developing monitoring plans, identifying and resolving queries, and verifying site regulatory binders' compliance.
- Nurture site relationships, providing guidance on startup procedures, addressing questions during the study, ensuring timely payments, and facilitating close-out activities.
- A minimum of 2 years of clinical research experience, preferably as a high-achieving research coordinator or CRA.
- Thorough knowledge of accepted Good Clinical Practice (GCP) and procedures.
- Exceptional organizational, time management, budget management, and problem-solving skills.
- Able to thrive in a fast-paced small company environment with a strong work ethic.
Estimated Annual Salary: $85,000 - $110,000 based on experience and location.
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