Site: The General Hospital Corporation

 

Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham.

 

 

Job Summary

Position Summary:
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.

 

Competencies Required:

• 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

Primary Duties:

• 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.

Other Tasks, as required:

• 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.

Education

• BA or BS required. Clinical research professional certification preferred (e.g., ACRP, SOCRA).

Experience

• Minimum of 2 years of experience in clinical research; 3–5 years preferred with a minimum of 1 year of monitoring experience.

• Experience in multi-center clinical trials and/or stroke, neurology, or outcomes research preferred.

• Demonstrated knowledge of ICH-GCP guidelines, federal regulations, and human subjects protections.

• Experience contributing to risk-based monitoring strategies or quality oversight initiatives preferred.

• Proficiency with Microsoft Office applications and clinical research data management systems.

• Demonstrated ability to manage monitoring responsibilities across multiple sites.

Knowledge, Skills and Abilities
- 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.

 

Physical Requirements

• Standing Frequently (34-66%)
• Walking Frequently (34-66%)
• Sitting Occasionally (3-33%)
• Lifting Frequently (34-66%) 35lbs+ (w/assisted device)
• Carrying Frequently (34-66%) 20lbs - 35lbs
• Pushing Occasionally (3-33%)
• Pulling Occasionally (3-33%)
• Climbing Rarely (Less than 2%)
• Balancing Frequently (34-66%)
• Stooping Occasionally (3-33%)
• Kneeling Occasionally (3-33%)
• Crouching Occasionally (3-33%)
• Crawling Rarely (Less than 2%)
• Reaching Frequently (34-66%)
• Gross Manipulation (Handling) Frequently (34-66%)
• Fine Manipulation (Fingering) Frequently (34-66%)
• Feeling Constantly (67-100%)
• Foot Use Rarely (Less than 2%)
• Vision - Far Constantly (67-100%)
• Vision - Near Constantly (67-100%)
• Talking Constantly (67-100%)
• Hearing Constantly (67-100%)

 

Remote

 

175 Cambridge Street

 

40

 

Regular

 

Day (United States of America)

 

Pay Range

$50,502.40 - $82,014.40/Annual

 

Grade

6

 

At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package.

 

1200 The General Hospital Corporation is an Equal Opportunity Employer. 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. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran’s Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at (857)-282-7642.

 

Mass General Brigham Competency Framework