Clinical Research Associate

4 weeks ago

Stanford, California, United States Experis Full time

Job Title: Clinical Research Associate

Job Summary:

We are seeking a highly skilled Clinical Research Associate to join our team at Experis. As a Clinical Research Associate, you will be responsible for coordinating multiple clinical research protocols, serving as the primary contact with research participants, sponsors, and regulatory agencies, and ensuring compliance with research protocols.

Key Responsibilities:

  • Recruit, screen, and consent participants, and coordinate protocol study visits and reviews adverse events with research participants, the PIs, Clinical Research Manager, sponsors, and regulatory agencies.
  • Responsible for regulatory oversight, initiating and maintaining IRB submissions, monitoring weekly billing reports, and coordination of site initiation, monitor and close-out visits.
  • Screen patients in the Lung Transplant clinics, and recruit participants for drug, tissue repositories, and observational Lung Transplant studies.
  • Collect and manage patient and laboratory data for clinical research projects. Manage research project databases, develop flow sheets and other study related documents, and complete study documents/case report forms.
  • Enter study data into existing electronic databases in accordance with each protocols guidelines.
  • Ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents.
  • Prepare regulatory submissions and ensure Institutional Review Board renewals are completed.
  • Address and resolve study queries, protocol deviations, or other audit or monitoring findings and reviews with a Research Manager as needed.
  • Responsible for IRB revisions and renewals and also the maintenance of current regulatory documents for all protocols.
  • Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact.
  • Prepare for study-related visits including preparation of study kits, appointment scheduling and monitoring meetings.
  • Serve as the primary contact for participants and sponsors with oversight by the Clinical Research Manager as needed.
  • Meet every other week with the PI and the Research Manager to review study progress, recruitment, AEs and compliance. Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements.
  • Interact with a variety of study sponsor and regulatory agencies that include the NIH auditors, industry-sponsored study monitors, and other foundation-sponsored research.
  • Meet weekly with the Clinical Research Manager to review and resolve any regulatory, budget, or other study-related issues.
  • Participate in monitor visits and regulatory audits.
  • Schedule monitor visits and/or regulatory audits and reviews in advance with the Clinical Research Manager and the PI of the study to prepare for each visit accordingly. Study monitor visits occur about every 3-6 months per each projects needs

About Experis:

Experis is a leading global workforce solutions company that helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. Our expert family of brands - Manpower, Experis, Talent Solutions, and Jefferson Wells - creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years.

We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent.

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