Clinical Research Coordinator - 239165
Medix - Lenexa, KS
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Seeking a Clinical Research Coordinator in Lenexa, KansasPosition: Clinical Research Coordinator Location: Lenexa, KansasHours: Monday-Friday; Onsite Pay: $55,000-60,000Duties:• Facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct ofthe study• Administer sponsor required questionnaires (i.e. VFQ)• Works with team member responsible for ordering study supplies (lab kits, shippers, etc.) to ensureadequate inventory is on hand• Ensures study staff is properly trained on study-related information (i.e. protocol, ICF, manuals,etc.) and that the training is documented• Creates, manages, and maintains source documents for each trial• Attends teleconferences and Investigator Meetings as requested by research director• Reviews and comprehends all study protocols, e.g., study proceedings and timelines, inclusion andexclusion criteria, confidentiality and privacy protections• Works with other members of the study team and clinical team to recruit eligible candidates to meetenrollment goals• Screens subjects for eligibility using protocol-specific inclusion and exclusion criteria, documentingeach potential participant's eligibility accurately• Efficiently completes all study tasks delegated to them (i.e. scribing, VFQ, IOP, etc.)• Collects updated medical history, adverse events and serious adverse events that need to be reportedto the sponsor and IRB within required time frame• Conducts and/or participates in the informed consent process/discussion with research participants,including answering any questions related to the study• Assures that amended consent forms are appropriately implemented and signed• Acts as a secondary reviewer to provide oversight so that the ICF process is conducted accurately• Collects data as required by the protocol and enters information into the electronic data capture(EDC) system in the specified timeframe indicated in the study contract.• Oversees data and ensures that it is being entered correctly and resolves any queries issued withinrequired time frame• Collects and reports ALL Adverse Events• Collects and reports ALL Serious Adverse Events• Responsible for ensuring all SUSAR/Safety Reports are acknowledged and reviewed• Coordinates monitor site visits and assists with preparation of site visit documentation• Works with the monitor to make any corrections needed to meet requirements and deadlines asneeded• Manages and maintains all regulatory information about the study including the protocol,investigator brochure, IRB documents, Investigator disclosures, CVs, training documentation,instructions on reporting requirements for the IRB and the sponsor• Obtain any applicable additional/required sponsor training and/or certifications
Created: 2025-02-14