Senior Clinical Research Coordinator

4 weeks ago


Kansas City, Missouri, United States US Tech Solutions Full time
Job Title: Senior Clinical Research Coordinator

Job Summary:
The Senior Clinical Research Coordinator is a key member of our clinical trials team, responsible for managing and overseeing the day-to-day operations of clinical trials. This includes recruiting and screening study participants, documenting and reporting on daily operations, and collaborating with the Principal Investigator to ensure productivity, quality, and timely completion of studies.

Responsibilities:
• Manage and oversee the day-to-day operations of clinical trials, including direct interactions with study participants.
• Regularly interface with current and potential clinical trial participants to determine eligibility and consent of study participants in alignment with clinical trial protocol.
• Create standard operating procedures (SOPs) that adhere to all Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) regulations.
• Contribute to the training of clinical trial staff and ensure compliance with operational requirements of the clinical trial.
• Function as participants' primary point of contact, keeping them informed on study progress and facilitating involvement of other study team members as needed.
• Manage participant visit scheduling and technical troubleshooting, escalating issues to the appropriate individual(s).
• Solicit and record information regarding safety events and prepare safety event documentation for review by the Principal Investigator.
• Provide accurate and timely data collection, documentation, entry, and reporting in both Sponsor and databases.
• Support the regulatory staff in the maintenance of regulatory documents in accordance with SOPs and applicable regulations.
• Communicate and collaborate 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, such as progress, adverse events, and enrollment.
• Maintain study supplies and issue appropriate participant stipends.
• Ensure appropriate credentialing and training of the study team.
• Facilitate meetings with study monitors, auditors, and investigators.
• Ensure timely response to queries and documentation of study-related issues.
• Disburse investigational product, manage inventory of equipment and study supplies, and provide patient education regarding administration, as necessary.
• Contribute to the development and implementation of tools, processes, and training to enhance the administration and execution of clinical studies.
• Accountable for site compliance with subject safety reporting and escalate issues.
• Demonstrate professionalism and apply basic leadership practices in all aspects of the role.
• Train and support study team members on a range of communication and teamwork best practices.
• Perform other duties related to clinical trials as delegated by the Principal Investigator.

Requirements:
• 3-5 years of Clinical Trial experience.
• Standard operating procedures (SOPs), Food and Drug Administration (FDA), Clinical Trials.
• High School Diploma or associate degree.

About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit our website. US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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