HealthCare Support
Senior Clinical Research Coordinator
HealthCare Support, Lenexa, Kansas, United States,
Clinical Senior Research Coordinator
HealthCare Support is actively seeking a
Clinical Senior Research Coordinator
to fill an opening with a
large healthcare organization
in
Lenexa, KS .
Daily Responsibilities for Clinical Senior Research Coordinator:Manages and oversees the day-to-day operations in the administration of clinical trial activities at the site-level (i.e., direct interactions with study participants)• Regularly interfaces with current and potential clinical trial participants to determine eligibility and consent of study participants in alignment with clinical trial protocol• Creates standard operating procedures (SOPs) that adhere to all Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) regulations• Contributes to the training of clinical trial staff and accountable for compliance with the operational requirements of the clinical trial• 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• Provides accurate and timely data collection, documentation, entry, and reporting in both Sponsor and Walgreens databases• Supports the regulatory staff in the maintenance of regulatory documents in accordance with Walgreens 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• Ensures appropriate credentialing and training of the study team• Facilitate meetings with the study monitors, auditors, and investigators• Ensure timely response to queries and documentation of study-related issues• If applicable, disburses investigational product, manages inventory of equipment and study supplies, and provides 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 (e.g., GCP, ALCOA-C)• Accountable for site compliance with subject safety reporting, 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• Performs other duties related to the clinical trials as delegated by the Principal Investigator
Shift: Monday-Friday 8am-5pm
Required Qualifications for Senior Clinical Research Coordinator:
3-5 years in clinical trial spaceWorking knowledge of ICH-GCP, US CFR, and HIPAA regulationsExperience working independently and making appropriate decisions to operationalize and move clinical trials forwardExperience overseeing multiple clinical trials concurrently, while maintaining attention to detailExperience prioritizing tasks and resources, meeting deadlines, and being adaptable to changing prioritiesProficient with phlebotomy (certification not mandatory). CRCs are expected to draw bloodHSD / GED
Benefits for Senior Clinical Research Coordinator:
Immediate enrollment in Health InsuranceDental InsuranceLife InsuranceEmployee Assistance Program (EAP)Access to Investment AccountsCareer and educational tools within our Ingenovis ACT (Advocacy) Program
Pay Details: $48.00 per hour - $56.00 per hour
Interested in being considered?If you are interested in applying to this position, please click Apply Now for immediate consideration.
For additional consideration, please email a copy of your resume to patrick.jamito@healthcaresupport.com with your phone number, the job title and location, and our recruiters will reach out.Healthcare Support Staffing, LLC is an equal employment opportunity employer and will consider all qualified applicants without regard to race, color, religion, disability, sex, sexual orientation, gender identity, national origin, protected veteran status, or any other characteristic protected by applicable local, state, or federal law.
#Gld1024
HealthCare Support is actively seeking a
Clinical Senior Research Coordinator
to fill an opening with a
large healthcare organization
in
Lenexa, KS .
Daily Responsibilities for Clinical Senior Research Coordinator:Manages and oversees the day-to-day operations in the administration of clinical trial activities at the site-level (i.e., direct interactions with study participants)• Regularly interfaces with current and potential clinical trial participants to determine eligibility and consent of study participants in alignment with clinical trial protocol• Creates standard operating procedures (SOPs) that adhere to all Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) regulations• Contributes to the training of clinical trial staff and accountable for compliance with the operational requirements of the clinical trial• 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• Provides accurate and timely data collection, documentation, entry, and reporting in both Sponsor and Walgreens databases• Supports the regulatory staff in the maintenance of regulatory documents in accordance with Walgreens 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• Ensures appropriate credentialing and training of the study team• Facilitate meetings with the study monitors, auditors, and investigators• Ensure timely response to queries and documentation of study-related issues• If applicable, disburses investigational product, manages inventory of equipment and study supplies, and provides 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 (e.g., GCP, ALCOA-C)• Accountable for site compliance with subject safety reporting, 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• Performs other duties related to the clinical trials as delegated by the Principal Investigator
Shift: Monday-Friday 8am-5pm
Required Qualifications for Senior Clinical Research Coordinator:
3-5 years in clinical trial spaceWorking knowledge of ICH-GCP, US CFR, and HIPAA regulationsExperience working independently and making appropriate decisions to operationalize and move clinical trials forwardExperience overseeing multiple clinical trials concurrently, while maintaining attention to detailExperience prioritizing tasks and resources, meeting deadlines, and being adaptable to changing prioritiesProficient with phlebotomy (certification not mandatory). CRCs are expected to draw bloodHSD / GED
Benefits for Senior Clinical Research Coordinator:
Immediate enrollment in Health InsuranceDental InsuranceLife InsuranceEmployee Assistance Program (EAP)Access to Investment AccountsCareer and educational tools within our Ingenovis ACT (Advocacy) Program
Pay Details: $48.00 per hour - $56.00 per hour
Interested in being considered?If you are interested in applying to this position, please click Apply Now for immediate consideration.
For additional consideration, please email a copy of your resume to patrick.jamito@healthcaresupport.com with your phone number, the job title and location, and our recruiters will reach out.Healthcare Support Staffing, LLC is an equal employment opportunity employer and will consider all qualified applicants without regard to race, color, religion, disability, sex, sexual orientation, gender identity, national origin, protected veteran status, or any other characteristic protected by applicable local, state, or federal law.
#Gld1024