Clinical Research Associate/Monitor II----Cancer Center Protocol Office

GENERAL SUMMARY/OVERVIEW STATEMENT:

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 clinical trials. PCORP is seeking candidates to conduct monitoring of Cellular Therapy clinical trials.

The Clinical Research Associate/Monitor works under general supervision to provide regulatory oversight and monitoring for a portfolio of Investigator-initiated, clinical research trials. The Monitor position ensures Sponsor and site regulatory adherence, source verifies data, monitors data quality and completeness and assesses protocol compliance across participating trial sites. This role focuses on trial quality assurance and does not include direct patient contact.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

The CRA/Monitor will perform the following 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 a
• Conduct onsite and remote monitoring visits and complete corresponding monitoring reports (Domestic travel required for onsite monitoring is <15%)




• Collaborate with study team to schedule monitoring visit and exit interview
• Perform source document verification
• Review study site regulatory and essential documents for completeness and accuracy
• Perform drug accountability and DARF verification
• Evaluate ongoing protocol and data compliance
• Issue, track and resolve queries




• Formulate and implement corrective action plans for major non-compliance; ensure follow-through by study team
• Communicate and escalate ongoing compliance issues to study leadership
• Provide guidance and consultation on best practices for data capture and documentation maintenance
• Assist team with other regulatory or coordination tasks as needed

SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:

• Careful attention to details
• Superior organizational and time management skills and ability to prioritize multiple tasks
• Analytical 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
• Working knowledge of clinical research protocols
• Ability and willingness to travel nationally

• Ability to work independently with general supervision
• Excellent judgment and ability to interpret information and protocol requirements

EDUCATION:

• Bachelor's degree required

EXPERIENCE:

• Minimum of 2 years of directly related work experience in clinical research (trial coordination, quality assurance and/or monitoring)

SUPERVISORY RESPONSIBILITY:

• A Clinical Research Associate/Monitor II may assist with the training and orientation of new staff members

FISCAL RESPONSIBILITY:

• Monitors are responsible for conducting onsite monitoring visits in adherence to institutional travel and expense policies and for submitting expense documentation in a timely fashion

WORKING CONDITIONS:

* Duties will mainly be performed in a remote setting; limited on-site presence anticipated. Applicants may work in all states with the following exceptions: WY, ND, Puerto Rico, and the U.S. Virgin Islands.

* Less than 15% domestic travel (1-2 field visits per quarter)

* Does not include patient contact

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.