Clinical Research Coordinator II - Clinical Trials

Job Description

This role follows a hybrid schedule, with 4 days onsite and 1 day remote. The schedule may require additional onsite presence based on patient needs, study activities, and operational priorities.

This is an opportunity to join an incredible team of staff and physicians who are committed to improving the lives of patients through meaningful clinical research. The team values collaboration, celebrates wins and achievements, and supports one another in delivering high-quality patient care and study outcomes.

The Clinical Research Coordinator II works independently providing study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. Presents information at regular research staff meetings. May plan and coordinate strategies for increasing patient enrollment, improving efficiency, training of personnel, or identifying new research opportunities. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).

The ideal candidate will have prior treatment experience as a Clinical Research Coordinator, preferably in oncology, although oncology experience is not required. Candidates should also have experience coordinating clinical trials across multiple electronic data capture (EDC) systems and be comfortable managing study data, documentation, and timelines with accuracy and attention to detail.

• 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.
• Schedules 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.
• Maintains 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.
• Schedules and participates 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.
• Notifies direct supervisor about concerns regarding data quality and study conduct.
• Works 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 perform other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.
• Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA and local Institutional Review Board.
• Maintains research practices using Good Clinical Practice (GCP) guidelines.
• Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
• May coordinate training and education of other personnel.
• May participate in centralized activities such as auditing, Standard Operating Procedure development, etc.
• May plan and coordinate strategies for increasing patient enrollment, and/or improving clinical research efficiency.
• May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.
• May identify new research opportunities and present to investigators
• Participates in required training and education programs.

Qualifications

This role follows a hybrid schedule, with 4 days onsite and 1 day remote. The schedule may require additional onsite presence based on patient needs, study activities, and operational priorities.

Education

• High School Diploma/GED - minimum
• Bachelor's Degree Science, Sociology or related degree - preferred

Experience

• 2 years Clinical research related experience - minimum

Licenses and Certifications

• • preferred SOCRA or ACRP certification