Clinical Research Associate-Cancer Center Protocol Office

Clinical Research Associate-Cancer Center Protocol Office

GENERAL SUMMARY/OVERVIEW STATEMENT:

The Cancer Center Protocol Office is seeking motivated, detail-oriented individuals to join our team as a Clinical Research Associate. The Cancer Center Protocol Office is a centralized research office that supports Clinical Researchers in all disciplines within the Cancer Center. Our office promotes and facilitates Clinical Research by providing comprehensive services to physicians conducting clinical trials while ensuring compliance with all regulatory requirements.

The Clinical Research Associate I (CRA I) works under general supervision to enroll eligible patients to Clinical Research protocols and manage data collection and regulatory submissions for multiple cancer studies. The CRA I will be the liaison between the clinical team, sponsor, and Institutional Review Board (IRB) to ensure appropriate communication and reporting. The CRA I will be trained on the institutional and federal regulations governing Clinical Research. The position involves a high volume of data abstraction and data entry. This position does not include any direct patient contact.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

The CRA I will perform the following data management duties 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 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
• 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:

• Careful attention to detail
• Good organizational skills
• Ability to follow directions
• Good communication skills
• Computer literacy
• Working knowledge of Clinical Research protocols
• Ability to demonstrate respect and professionalism for subjects rights and individual needs

LICENSES, CERTIFICATIONS, AND/OR REGISTRATIONS:

• None

EDUCATION:

• BA/BS degree required

EXPERIENCE:

• None

SUPERVISORY RESPONSIBILITY:

• None

WORKING CONDITIONS:

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

Massachusetts General Hospital is an Affirmative Action Employer. By embracing diverse skills, perspectives, and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment