Sr. Clinical Research Coordinator

Summary:

The Sr. Clinical Research Coordinator is responsible for the management and coordination of clinical research studies under the direction of the principal investigator (PI) and clinical research manager.

This role involves ensuring compliance with all regulatory requirements, maintaining data integrity, and managing study logistics to support the successful completion of clinical trials.

Responsibilities :

·      Coordinate and manage clinical trials from initiation to completion.

·      Develop and maintain study documents, including protocols, informed consent forms, and case report forms.

·      Ensure studies are conducted by Good Clinical Practice (GCP) guidelines and all applicable regulations.

·      Screen, recruit, and enroll study participants.

·      Obtain informed consent from participants.

·      Schedule and conduct study visits, follow-ups, and assessments.

·      Maintain effective communication with study participants to ensure adherence to study protocols.

·      Collect, process, and maintain accurate and complete study data.

·      Enter data into electronic data capture systems and ensure timely data entry.

·      Monitor data quality and resolve data queries.

·      Prepare and submit regulatory documents to Institutional Review Boards (IRBs) and other regulatory bodies.

·      Ensure compliance with all regulatory requirements, including reporting adverse events and protocol deviations.

·      Train and mentor junior research staff and clinical research coordinators.

·      Stay current with industry best practices and regulatory changes through ongoing professional development.

·      Maintain study-related documentation and records to regulatory requirements.

·      Serve as a liaison between the PI, research team, study participants, and external stakeholders.

·      Coordinate with study sponsors, monitors, and other external parties.

·      Participate in study team meetings and provide regular updates on study progress.

Qualifications:

·      Bachelor’s degree in a related field (e.g., nursing, life sciences, public health) preferred.

·      Minimum of 3-5 years of experience in clinical research coordination.

·      Must be local to the Orange County area.

·      Certification as a Clinical Research Coordinator (CCRC) or Clinical Research Professional (CCRP) preferred.

·      Strong knowledge of GCP, FDA regulations, and IRB procedures.

·      Excellent organizational, communication, and interpersonal skills.

·      Proficiency in electronic data capture systems and Microsoft Office Suite.

·      Ability to work independently and as part of a multidisciplinary team.

·      Detail-oriented with strong problem-solving skills.