Clinical Research Coordinator I - Women's Health (Los Angeles, CA)

We are looking for a Clinical Research Coordinator I to independently coordinate and manage clinical research studies while ensuring compliance with regulatory requirements and organizational standards. The ideal candidate will excel in screening potential patients, coordinating study activities, and managing data collection and documentation with precision and timeliness. This role requires a detail-oriented professional who is well-versed in Good Clinical Practice (GCP) guidelines and regulatory compliance, with a strong commitment to maintaining patient confidentiality and research integrity.
 

• Independently coordinate studies, including screening potential patients for protocol eligibility, presenting non-medical trial concepts, and participating in the informed consent process.
• Schedule patients for research visits and procedures.
• Collaborate with physicians and medical personnel to document patient conditions, adverse events, protocol compliance, and responses to study drugs on Case Report Forms (CRFs).
• Maintain accurate source documents for all research procedures.
• Collect, document, enter, and report data accurately and in a timely manner, including responding to sponsor queries.
• Schedule and participate in monitoring and auditing activities.
• Compile and report study-related information, such as protocol activity, accrual data, and workload, and present findings during research staff meetings.
• Notify supervisors of concerns regarding data quality and study conduct.
• Collaborate with regulatory coordinators or Institutional Review Boards (IRB) to submit adverse events, protocol deviations, and safety letters in accordance with federal and local guidelines.
• Perform regulatory/IRB duties, budget management, and assist with patient research billing and reconciliation as needed.
• Ensure compliance with FDA, IRB, and other federal/local regulations.
• Uphold research practices following Good Clinical Practice (GCP) guidelines and maintain strict patient confidentiality per HIPAA regulations.
• Participate in required training and educational programs.

• Education:

  • High School Diploma/GED required.
  • Bachelor’s Degree in Science, Sociology, or a related field preferred.

• Licenses:

  • SOCRA or ACRP Certification preferred upon hire.

• Experience:

  • Minimum of one (1) year of clinical research-related experience required.

Department: Direct Clients
This is a full time position