The Program for the Coordination and Oversight of Research Protocols (PCORP) within the MGH Cancer Center Protocol Office specializes in the central coordination, monitoring and regulatory oversight of Investigator-initiated, multi-center clinical trials. PCORP is seeking Clinical Research Associate (CRA) candidates to assist with the coordination and monitoring of multiple oncology trials.
The multi-center CRA works under general supervision to maintain regulatory files and monitor data quality and data and protocol compliance across participating study sites. The CRA will be trained on the institutional and federal regulations governing clinical research. The position involves a high volume of regulatory document coordination and tracking and clinical data review. This position does not include any direct patient contact.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
The CRA will perform the following duties under general supervision by the Clinical Research Manager:
Track the progress of the trial across all participating sites (e.g., accrual, biospecimen collection and transfer, reportable events, regulatory submissions)
Correspond with participating sites to support trial activities as needed:
Answer questions about eligibility, study procedures or data entry
Prepare and distribute informational updates, including meeting minutes, missing data reports and safety reports
Communicate essential trial information and documentation, including protocol amendments; request routine updates from sites to maintain current study status
Facilitate database reviews and query resolution
• Present the Sponsor-Investigator study status reports related to trial progress and assigned tasks
Verify adequate documentation of consent, required screening tests and procedures, and eligibility criteria to ensure patients meet all inclusion/exclusion criteria
Conduct onsite and remote monitoring visits and complete corresponding monitoring reports (Domestic travel required for onsite monitoring < 25%)
Perform source document verification and drug accountability
Review study site regulatory binder and essential documents for completeness and accuracy
Evaluate ongoing protocol and data compliance
Issue, track and resolve queries
• Gather, track and organize essential regulatory documents from participating sites
• Facilitate and document Sponsor-Investigator review of safety reports, investigational drug brochure updates, study violations and adverse events
Submits routine and expedited reports to the FDA, IRB, funding sponsor or other stakeholders.
SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:
Careful attention to details
Superior organizational and time management skills and ability to prioritize multiple tasks
Problem-solving skills, including the ability to gather information, identify resources, and develop alternatives
Excellent written and oral communication skills
Able to work successfully in a fully remote environment
Demonstrate initiative and accountability
Ability and willingness to travel nationally.
The Clinical Research Associate II should also possess:
Working knowledge of clinical research protocols
Ability to work independently with general supervision
Analytical skills and ability to identify and resolve problems and develop alternatives
Excellent judgment and ability to interpret information and protocol requirements
Qualifications
EDUCATION:
Bachelor's degree required
EXPERIENCE:
Minimum of 1-2 years of directly related work experience
SUPERVISORY RESPONSIBILITY:
• A Clinical Research Associate II may assist with the training and orientation of new staff members
FISCAL RESPONSIBILITY:
CRAs are responsible for conducting onsite monitoring visits in adherence to institutional travel policy and submitting expense documentation in a timely fashion.
WORKING CONDITIONS:
• Duties will mainly be performed in a remote setting; limited in-office presence anticipated. Applicants may work in all states with the following exceptions: WY, ND, Puerto Rico, and the U.S. Virgin Islands.
• Less than 25% domestic travel (1-2 field visits per month maximum)
• Does not include patient contact
EEO Statement
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.
