Clinical Study Assistant

Eastridge Workforce Solution is looking for a Clinical Study Assistantfor a company that uses innovative continuous glucose monitoring (CGM) systems to help people take control of their diabetes. This is a remote contract to hire position.

Essential Duties and Responsibilities:

• Partner with Clinical Affairs management to develop and execute clinical studies.
• Communicate progress updates to Clinical Affairs management and the various functional groups (R&D, Biostats, Clinical Operations).
• Write/reviews protocols, and study reports in consultation of CRA personnel and/or study manager.
• Develop Clinical Study materials (including, but not limited to, source documentation, CRFs, IRB submissions, training slides, etc.) under direct supervision of study lead and/or study manager.
• Maintain thorough understanding of clinical regulations and standards (including changing regulations).
• Complete study monitoring visits.
• Assist with documenting initial and re-qualification of new clinical sites
• Act as primary contact for company-Sponsored clinical sites.
• Act as lead coordinator or monitor for Sponsor-Investigator studies.
• Provide training to study staff and subjects at clinical sites.
• Collaborate effectively with peers and leadership across departments and can professionally interact/build relationships with FDA, IRB, and key opinion leaders.
• Responsible for identifying and escalating safety events for Sponsor-Investigator and company-Sponsored studies.
• Responsible for identifying and escalating major protocol deviations for Sponsor-Investigator and company-Sponsored studies.
• May assist with assessing trends for safety and protocol deviations and communicating this to study team and study manager
• Maintain organization, preparation and ordering of supplies and equipment required for clinical studies.
• Assist with the management of studies by coordinating daily operations including methods, workflow and implementation of procedures.
• Set-up IT equipment for Sponsor-Investigator and company-Sponsored sites.
• Complete testing of electronic data capturing systems.
• Quality control SME for study-related documents and be accountable for their correct distribution.
• Provide support to CRA personnel for preparing documentation, reports, and presentations.
• Coordinate study-related meetings, as needed.
• Coordinate Sponsor-Investigator studies and complete all study-related responsibilities.
• Maintain tracking mechanism for regulatory documents for any regulatory submission (FDA or other regulatory body).
• Prepare of key documents for trial site submission to IRBs.

Experience and Education Requirements:

• Bachelor’s (BA or BS) degree in a STEM discipline, and at least 8 years of related experience, or Master’s degree in a STEM discipline, and 5 years of related experience.
• Current GCP (Good Clinical Practice) Training.
• Clinical Trial Management System (CTMS) experience.
• Manage multiple, diversified tasks concurrently and to prioritize projects and tasks effectively.
• Monitoring clinical studies experience.

Preferred Qualifications:

• Professional certification (e.g., CCRA (ACRP), CCRP (SoCRA), PMP, ACRP, RAPS).
• Study coordinator experience.

Travel Required:

• 25-50%.
• Local to San Diego, California or willing to relocate OR may work remotely elsewhere, with approval.

Benefits: Use this link bit.ly/2023-Benefits to learn more about benefits available to Eastridge’s temporary employees.From time to time Eastridge’s clients may offer additional benefits to Eastridge employees while on assignment.Information about those benefits will be communicated when applicable.

Eastridge Workforce Solutions is an equal opportunity employer and all qualified applicants will receive consideration for employment 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. We celebrate diversity and are committed to creating an inclusive environment for all employees. Please note that Eastridge is unable to provide visa sponsorship to applicants.

We value diverse experiences, including prior contact with the criminal legal system, and applicants with criminal histories are encouraged to apply.Certain clients require Eastridge to perform background checks and Eastridge will consider qualified applicants with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring, and the San Francisco Fair Chance Ordinance.

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