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 clinical 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. We are currently hiring Clinical Research Associates for multiple disease groups within the Cancer Center.
The Clinical Research Associate works under general supervision to enroll eligible patients to clinical research protocols while managing the data collection and regulatory submissions for multiple cancer research studies. The Clinical Research Associate is the liaison between the clinical research team, sponsor and Institutional Review Board (IRB) to ensure appropriate communication and reporting. The Clinical Research Associate will be trained on the institutional and federal regulations governing clinical research and apply that knowledge to the coordination of research activities for assigned studies. This position involves a high volume of data abstraction and data entry and does not include direct patient contact.
This is a full-time position (40 hours per week) and will involve a combination of on-site and remote work. This position is ideal for someone that is eager to learn about clinical research and the regulatory framework that governs human subject research and has the potential for growth and advancement within the team.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
The Clinical Research Associate will perform the following data management duties:
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 Clinical Research Associate will perform the following regulatory duties:
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:
A successful candidate will exhibit the following skills:
Careful attention to detail
Good organizational skills
Ability to follow directions
Good communication skills
Working knowledge of clinical research protocols
Ability to demonstrate respect and professionalism for subjects rights and individual need
Duties will be performed in a combination of on-site and remote setting
Massachusetts General Hospital is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. Applications from protected veterans and individuals with disabilities are strongly encouraged.