Medix™
We are looking for an experienced Lead CRC to join an exciting new research site in Northeast Phoenix. Interested applications must have at least 3 years of CRC experience working on complex studies. The end goal is to be groomed into a Site Manager. This role is 100% ON SITE.
Helping Sponsors take their products from conception ➡ commercialization Responsibilities
Conduct clinical trial activities per protocol and FDA, ICH, GCP, GDP standards.
Serve as the primary point of contact for day-to-day clinical trial operations and escalation of issues for CRC I and II staff.
Provide mentorship, training, and support to junior CRCs, assisting with onboarding and ongoing development.
Oversee the delegation of study tasks to ensure even distribution of workload and adherence to timelines.
Coordinate cross-functional teams to ensure all pre-study, initiation, and ongoing trial activities meet sponsor and regulatory requirements.
Develop and implement site-specific workflows and protocols to optimize efficiency and compliance.
Independently manage complex trials, including those involving investigational products, high volumes, or unique challenges.
Ensure adherence to Good Clinical Practice (GCP), FDA regulations, IRB guidelines, and sponsor protocols.
Conduct routine quality assurance reviews of documentation, source data, and regulatory files, providing feedback for corrections or improvements.
Facilitate site audits and sponsor monitoring visits, serving as the lead point of contact.
Act as the primary liaison for sponsors, CROs, and regulatory bodies regarding study updates, issues, and corrective actions.
Ensure study participants are supported and informed throughout the research process, addressing escalated concerns as needed.
Monitor site performance metrics and propose improvements to enhance operational efficiency.
Oversee inventory management for investigational products, study supplies, and equipment.
Coordinate training and preparedness of staff for emergency unblinding or adverse event protocols.
Represent the site at Investigator Meetings (IM) and external conferences, providing post-meeting updates to the team.
Seniority level Mid-Senior level
Employment type Full-time
Job function Research, Science, and Health Care Provider
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Helping Sponsors take their products from conception ➡ commercialization Responsibilities
Conduct clinical trial activities per protocol and FDA, ICH, GCP, GDP standards.
Serve as the primary point of contact for day-to-day clinical trial operations and escalation of issues for CRC I and II staff.
Provide mentorship, training, and support to junior CRCs, assisting with onboarding and ongoing development.
Oversee the delegation of study tasks to ensure even distribution of workload and adherence to timelines.
Coordinate cross-functional teams to ensure all pre-study, initiation, and ongoing trial activities meet sponsor and regulatory requirements.
Develop and implement site-specific workflows and protocols to optimize efficiency and compliance.
Independently manage complex trials, including those involving investigational products, high volumes, or unique challenges.
Ensure adherence to Good Clinical Practice (GCP), FDA regulations, IRB guidelines, and sponsor protocols.
Conduct routine quality assurance reviews of documentation, source data, and regulatory files, providing feedback for corrections or improvements.
Facilitate site audits and sponsor monitoring visits, serving as the lead point of contact.
Act as the primary liaison for sponsors, CROs, and regulatory bodies regarding study updates, issues, and corrective actions.
Ensure study participants are supported and informed throughout the research process, addressing escalated concerns as needed.
Monitor site performance metrics and propose improvements to enhance operational efficiency.
Oversee inventory management for investigational products, study supplies, and equipment.
Coordinate training and preparedness of staff for emergency unblinding or adverse event protocols.
Represent the site at Investigator Meetings (IM) and external conferences, providing post-meeting updates to the team.
Seniority level Mid-Senior level
Employment type Full-time
Job function Research, Science, and Health Care Provider
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