Job Description
Job Description
Research & Development Institute (RDI) is a tech-enabled CRO that helps In Vitro Diagnostic manufacturers who struggle to get FDA clearance for their products by sourcing the blood samples they desperately need through physicians and labs.
RDI received a large investment in 2021 that has allowed it to transition from a founder led business into a world-class diagnostic CRO with scientific experts and a CLIA lab that allow it to manage larger and more profitable projects.
RDI is seeking a Senior Clinical Associate to ensure our clinical trials are completed on-time, according to the protocol, and keeping our clients and sites informed throughout the process.
This is a long term career position with significant room for growth as our company expands nationwide. Further, RDI will assist, support, and expect the candidate to be trained and apply for SOCRA CRA certification.
Responsibilities
- Manage diagnostic clinical studies (these are relatively simple medical device studies when compared to pharmaceutical trials)
- Develop and manage the protocol, case report form, budget / contract negotiation and regulatory document management
- Assist clinical sites with IRB submission / documentation, as needed
- Setup and keep Diagnostica (our remote clinical trial management system up to date)
- Monitor clinical studies develop monitoring plans, identify, issue and resolve queries, ensure site regulatory binders are compliant
- Manage site relationships - help them with startup, answer questions during the study, ensure timely payments and close out activities
Skills & Requirements
- A minimum of 2 years clinical research experience (either as a high-achieving research coordinator or CRA)
- Knowledge of accepted good clinical research practice (GCP) and procedures
- Excellent organizational, time management, budget management, and problem-solving skills
- Hustle : Comfortable in a fast-paced small company environment
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