Clinical Research Associate/Clinical Research Monitor

Mass General Brigham•Boston, MA

21h•Remote

About The Position

The Clinical Research Associate/Clinical Research Monitor (CRA) plays a key role in the quality oversight and regulatory integrity of a large, high-profile, multi-center NIH-funded stroke outcomes study enrolling and following 8,000 participants across 20 U.S. sites. The CRA is responsible not only for conducting risk-based monitoring activities in accordance with ICH-GCP guidelines, federal regulations, study SOPs and the approved monitoring plan, but also for contributing to the ongoing refinement of the study’s quality oversight strategy. This includes proactively evaluating site performance trends, identifying emerging risks, and recommending monitoring and quality control adaptations aligned with the study’s lifecycle (startup, peak recruitment, retention-focused follow-up, and close-out). This role requires advanced clinical research expertise, strong regulatory knowledge, independent judgment, and the ability to partner closely with study leadership to ensure participant safety, data integrity, and operational excellence across a complex, multi-site network.

Requirements

Excellent oral and written communication skills
Strong interpersonal and relationship-building skills with investigators and site staff
Ability to work independently with a high degree of accountability
Ability to travel up to 10% of the time for meetings and on-site monitoring visits
Ability to identify operational, regulatory, or quality risks and develop strategic, solution-oriented recommendations
Exceptional attention to detail and strong organizational skills
Proficiency navigating and utilizing multiple online systems and software platforms
Advanced knowledge of ICH-GCP guidelines, federal regulations, and human subjects protections
Ability to analyze performance metrics and develop and implement risk-based quality management strategies
BA or BS required.
Minimum of 2 years of experience in clinical research; 3–5 years preferred with a minimum of 1 year of monitoring experience.
Demonstrated knowledge of ICH-GCP guidelines, federal regulations, and human subjects protections.
Proficiency with Microsoft Office applications and clinical research data management systems.
Demonstrated ability to manage monitoring responsibilities across multiple sites.
Ability to work independently and as a team member.
Strong attention to detail and organizational skills.
Knowledge of clinical research protocols.
Knowledge of data management programs.
Computer literacy.
Knowledge of clinical trials, research, and general medicine.

Nice To Haves

Clinical research professional certification preferred (e.g., ACRP, SOCRA).
Experience in multi-center clinical trials and/or stroke, neurology, or outcomes research preferred.
Experience contributing to risk-based monitoring strategies or quality oversight initiatives preferred.

Responsibilities

Conduct site monitoring visits (including Site Qualification Visits, Site Initiation Visits, Monitoring Visits, and Close-Out Visits) in accordance with the approved monitoring plan.
Exercise partial ownership of the study’s quality oversight framework by evaluating the effectiveness of the existing monitoring plan and recommending strategic revisions based on study phase, enrollment status, retention priorities, protocol amendments, monitoring findings, and site performance trends.
Collaborate with study leadership to implement adaptive monitoring approaches, including modifications to visit frequency, scope of review, central versus on-site monitoring balance, and targeted risk mitigation strategies.
Assess site compliance with the study protocol, informed consent requirements, IRB approvals, and regulatory obligations, ensuring protection of participant rights and safety.
Perform source data verification and source document review to ensure that data entered into electronic case report forms (eCRFs) are accurate, complete, and verifiable from source documentation.
Identify systemic data quality trends or recurring compliance issues and provide recommendations for corrective and preventive actions (CAPA) at both the site and study-wide levels.
Review and assess essential regulatory documents, including IRB documentation, delegation logs, training logs, and protocol deviation logs
Ensure timely resolution of data queries and protocol deviations in collaboration with site personnel and the Coordinating Center.
Provide study-specific training to investigators and site staff throughout the study lifecycle, reinforcing protocol adherence and regulatory best practices.
Maintain regular communication with sites to support enrollment, data quality, retention efforts, and adherence to study procedures.
Document monitoring activities, findings, and follow-up actions through detailed monitoring reports and formal correspondence within established timelines.
Report significant findings, trends, or compliance concerns to study leadership and contribute to action planning discussions.
Participate in weekly study team meetings and actively contribute to discussions regarding site performance metrics, quality indicators, and strategic oversight planning.
Participate in site and/or investigator selection processes, providing input regarding site readiness and risk profile.
Contribute to the development and refinement of monitoring tools, risk assessment frameworks, tracking systems, and quality improvement initiatives.
Perform central monitoring activities, including analysis of recruitment trends, retention metrics, protocol deviation patterns, and data quality dashboards.
Support preparation for sponsor reviews or regulatory inspections, including documentation review and corrective action planning.
Attend and participate in investigator meetings, coordinator meetings, and study training sessions as needed.
Submit monitoring visit expense reports and administrative documentation in a timely manner.