Clinical Trials Coordinator
1 week ago
We are seeking a dedicated Clinical Trials Coordinator who is prepared to advance their professional journey. At Medix™, our team is growing, and we require an individual capable of overseeing clinical trials from initiation to completion. We provide ample opportunities for career advancement along with a competitive salary and comprehensive benefits.
Essential Qualifications
- A Bachelor's Degree and/or a minimum of 3 years' experience as a clinical research coordinator within the industry.
- The ideal candidate is meticulous, dependable, and adept at managing multiple tasks in a dynamic, high-volume environment.
Key Responsibilities
- Facilitates and coordinates daily activities of clinical trials, playing a vital role in the execution of the study.
- Develops, manages, and maintains essential documentation for each trial.
- Participates in teleconferences and Investigator Meetings as directed by the research director.
- Thoroughly reviews and understands all study protocols, including study procedures, timelines, eligibility criteria, and confidentiality measures.
- Efficiently executes all assigned study tasks (e.g., scribing, VFQ, IOP, etc.).
- Gathers updated medical histories, adverse events, and serious adverse events that must be reported to the sponsor and IRB within the required timeframe.
- Ensures that revised consent forms are properly implemented and signed.
- Acts as a secondary reviewer to ensure the informed consent process is conducted accurately.
- Collects data as mandated by the protocol and inputs information into the electronic data capture (EDC) system within the specified timeframe outlined in the study contract.
- Monitors data entry for accuracy and resolves any queries within the required timeframe.
- Responsible for acknowledging and reviewing all SUSAR/Safety Reports.
- Coordinates site monitoring visits and aids in the preparation of site visit documentation.
- Collaborates with monitors to make necessary corrections to meet compliance requirements and deadlines.
- Manages and maintains all regulatory documentation related to the study, including the protocol, investigator brochure, IRB documents, investigator disclosures, CVs, training records, and reporting instructions for the IRB and sponsor.
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