Clinical Research Coordinator III - Guerin Children's - Pediatrics (On-Site)

Come join our team!

The Clinical Research Coordinator III (CRC-III) provides support from initiation through closeout for all Guerin Children's clinical research studies, including ancillary service coordination, patient recruitment and enrollment, data collection, and compliance assurance.

The CRC-III is an experienced coordinator with ample prior clinical trial experience in order to assist with multiple studies at one time, across various specialties, and of differing classifications.

The CRC-III is accountable for rapid study start-up, ensuring timely attainment of study milestones, as well as building and maintaining strong relationships with sponsors and internal collaborating offices.

Primary Duties & Responsibilities :

Responsible for oversight of all studies and the assignment of studies to clinical research personnel within the group.

Manages the research portfolio and daily operations for the investigator or disease group.

• Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process.
• Scheduling of patients for research visits and procedures.
• In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following;

changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug.

• Maintain accurate source documents related to all research procedures.
• Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.
• Schedule and participate in monitoring and auditing activities.
• Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information;

present this information at regular research staff meetings.

• Notify direct supervisor about concerns regarding data quality and study conduct.
• Work closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
• May involve other regulatory / IRB duties, budgeting duties, and assisting with patient research billing and reconciliation.
• Ensure compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
• Maintain research practices using Good Clinical Practice (GCP) guidelines.
• Maintain strict patient confidentiality according to HIPAA regulations and applicable law.
• Participate in required training & education program. Work with Training and Education Coordinator to ensure all staff is properly trained and certified.
• Participate in centralized activities such as auditing, Standard Operating Procedure development, etc.
• Plan and coordinate strategies for increasing patient enrollment, and / or improving clinical research efficiency.
• Identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.
• Identify new research opportunities and presents to investigators.
• Supervise other research staff.

Qualifications :

• High School Diploma / GED required. Bachelor's Degree in Science, Sociology, or related degree preferred
• Certification in Clinical Research (. SOCRA or ACRP) preferred
• 4 years of clinical research related experience required. 5-7 years of directly related experience strongly preferred.
30+ days ago