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Clinical Research Coordinator
3 months ago
Location: North Las Vegas, NV
Duration: 12 months
Description:
Contract Working knowledge of ICH-GCP, US CFR, and HIPAA regulations
Experience overseeing multiple clinical trials concurrently, while maintaining attention to detail
Experience prioritizing tasks and resources, meeting deadlines, and being adaptable to changing priorities
Preferred Qualifications & Interests (PQIs)
Proficient with phlebotomy
Decentralized/hybrid clinical trials experience
Manages clinical research studies and adheres to a Retail Pharmacy company 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 August 22, 2023 Page 2 of 3
This job description is to be used as a guide for accomplishing Company and department objectives, and only covers the primary functions and responsibilities of the position. It is in no way to be construed as an all-encompassing list of duties.
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 both Sponsor and a Retail Pharmacy company databases
Supports the regulatory staff in the maintenance of regulatory documents in accordance with a Retail Pharmacy company 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
As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
