Clinical Research Associate Director
5 days ago
R&D Institute is a cutting-edge Contract Research Organization (CRO) that helps In Vitro Diagnostic manufacturers overcome FDA clearance hurdles by sourcing the required blood samples through physicians and labs.
The company has undergone significant growth since receiving a substantial investment in 2021, transitioning from a founder-led business to a world-class diagnostic CRO with expert scientists and a CLIA-certified lab. This expansion has enabled R&D Institute to manage larger, more profitable projects.
We are seeking a seasoned Senior Clinical Associate to oversee our clinical trials, ensuring timely completion, adherence to protocols, and seamless communication with clients and sites throughout the process.
This long-term career opportunity offers significant room for growth as our company expands nationwide. Additionally, we will support and expect the candidate to pursue SOCRA CRA certification.
Responsibilities:
- Manage diagnostic clinical studies, focusing on medical device trials with relatively simple protocols compared to pharmaceutical trials.
- Develop and manage protocols, case report forms, budgets, contract negotiations, and regulatory document management.
- Assist clinical sites with IRB submissions and documentation, as needed.
- Maintain and update Diagnostica, our remote clinical trial management system.
- Monitor clinical studies, develop monitoring plans, identify and resolve queries, ensure site regulatory binders comply with regulations.
- Foster strong relationships with clinical sites, providing guidance during startup, addressing questions, ensuring timely payments, and closing out activities.
Requirements:
- A minimum of 2 years of clinical research experience, preferably as a high-achieving research coordinator or CRA.
- Knowledge of accepted good clinical practice (GCP) and procedures.
- Excellent organizational, time management, budget management, and problem-solving skills.
- An ability to thrive in a fast-paced environment.
Estimated annual salary: $80,000 - $110,000 based on location and experience.
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