Clinical Research Coordinator II

GENERAL SUMMARY/ OVERVIEW STATEMENT:

The Clinical Research Associate II (CRA II) works independently under general supervision to manage data collection and regulatory submissions for multiple cancer-related projects. The CRA II will be the liaison between the clinical team, research management, and Institutional Review Board (IRB) to ensure appropriate communication and reporting. The CRA II will have experience with institutional and federal regulations governing clinical research. The position involves a high volume of data abstraction and data entry. This position does not include direct patient contact. The CRA II works under general supervision of the Principal Investigator and reports to the Program Manager.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

The CRA II will perform the following data management duties independently under general supervision by the Clinical Research Manager:

• Verify adequate documentation of consent, required screening tests and procedures, and eligibility criteria to ensure patients meet all inclusion/exclusion criteria
• Enroll patients as required by the study sponsor and internal enrollment monitor team
• Follow patients for the duration of study participation via electronic medical record review to ensure protocol compliance
• Complete data entry as required for individual study protocols ensuring compliance with institutional and regulatory requirements.
• Monitor and report adverse events and deviations as required by the sponsor, institution, and federal regulations
• Maintain research charts and/or electronic files for all enrolled patients
• Ensure adequate source documentation is in place for all data reported
• Resolve data queries issued by the sponsor
• Obtain protocol clarifications from the study sponsor and communicate information to the research team
• Schedule and prepare for monitoring visits with sponsors
• Facilitate the request and shipment of archival pathology samples
• Organize and prepare for internal and external audits
• Maintain ongoing communication with clinical team regarding study patients and progress for multiple studies

The following regulatory duties may be performed independently under general supervision by the Clinical Research Manager:

• Maintain and organize study specific regulatory binders
• Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB
• Revise informed consent documents to include new risk information and/or updated protocol requirements through the course of the study
• Manage adverse event and deviation/violation/exception documentation for all enrolled patients and report to the sponsor and IRB as required
• Submit Data and Safety Monitoring Reports
• Submit requests for agreements to the Research Management or Innovations Office
• Maintain source documentation of correspondence with the IRB, investigators, and sponsors throughout the clinical trial process
• Collect, complete, and submit essential regulatory documents to various regulatory entities
• Participate in monitoring visits and file all monitoring visit correspondence
• Ensure appropriate documentation of delegation and training for all study staff members
• Maintain screening and enrollment logs

SKILLS/ABILITIES/COMPETENCIES REQUIRED:

• Ability to work independently and as a team member
• Analytical skills and ability to resolve problems
• Ability to interpret acceptability of data results
• Careful attention to detail
• Good organizational and communication skills
• High degree of computer literacy
• Working knowledge of clinical research protocols
• Ability to demonstrate respect and professionalism for subjects rights and individual needs

EDUCATION:

• BA/BS degree required

EXPERIENCE:

• Minimum of 1-2 years of related experience

WORKING CONDITIONS:

• Duties may be performed in a combination of on-site and remote work setting.