Job Details
This opportunity will be part of the clinical trials in a pharmacy. Bringing the trials to the people at their local pharmacy. The Clinical Research Coordinator (CRC) is responsible for the coordination and administration of clinical trials under the direction of the Director/Manager of Clinical Site Operations and the Principal Investigator or designee. Working in collaboration with the Principal Investigator, the CRC is a critical member of our organization and contribute to patient enrollment efforts in a variety of clinical trials. And will implement and coordinate research study procedures for the successful management of clinical trials.
Additional Responsibilities:
* Manages clinical research studies and adheres to Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), study protocols, clinical trial agreements, and regulations governing clinical research. Regularly interfaces with current and potential clinical trial participants to determine eligibility and consent of study participants in alignment with the clinical trial protocol.
* Coordinate research participant visits and study-related procedures according to study protocol windows and study team schedules, which many involve handling travel logistics for research participants; ensure reminder communications (phone, text, or email) are sent to promote research participant show rate and compliance; identity and outreach to prospective patients; prepare study visit materials such as lab kits, study form, and diaries for participants visits.
* Function as participants' primary point of contact, keeping them informed on the study progress, and facilitate involvement of other study team members, as needed (e. g., notify Principal Investigator of safety events)
* Manage participant visit scheduling and technical troubleshooting, escalating issues to the appropriate individual(s)
* Solicit and record information regarding safety events and preparing safety event documentation for review by the Principal Investigator
* Ensure scientific integrity of data and record source data appropriately and accurately, including patient visit data within the source, CTMS, electronic reporting systems, completing the sponsor's case report form, and timely query resolution.
* Provides accurate and timely data collection, documentation, entry, and reporting in multiple databases.
* Supports the regulatory staff in the maintenance of regulatory documents in accordance with SOPs and applicable regulations.
* Communicates and collaborates specific study requirements to the research team, including internal and external parties, sponsor, monitors, PI, and study participants.
* Maintain regular contact with the Principal Investigator and team to review study details (e. g., progress, adverse events, enrollment)
* Maintain study supplies and issue appropriate participant stipends * Conduct clinical research study visits/procedures per protocol requirements. This may require obtaining vital signs, height, weight, EKG's, spirometry, medical history, medications, adverse events, and labs, as well as administering questionnaires and diaries * Ensure timely response to queries and documentation of study-related issues.
* If applicable, disburses investigational product, manages the inventory of equipment and study supplies, and provides patient education regarding administration, as necessary.
* Monitor site compliance with subject safety reporting, escalate issues, and develop or contribute to the development of tools, processes, and training to enhance subject safety during the conduct of a clinical study
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Proficient with phlebotomy
Decentralized/hybrid clinical trials experience
-At least 1+ years of experience as a Clinical Research Coordinator in the clinical trail space
-Open to being onsite with a potential to work some hybrid.
-Experience overseeing multiple clinical trials concurrently, while maintaining attention to detail
-Working knowledge of ICH-GCP, US CFR, and HIPAA regulations
-Experience prioritizing tasks and resources, meeting deadlines, and being adaptable to changing priorities