Mass General Brigham
Overview
Site: Mass General Brigham Incorporated 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 The Center for Clinical Research Operations (CCRO) provides support across all Mass. Eye and Ear departments conduct clinical research and are structured to meet the education and quality standards for the conduct of clinical research. The position reports to the Associate Director of the CCRO within Research Management. Responsible for direct oversight of Project Managers and Study Coordinators; conducts hands-on training of Project Manager and Study Coordinator staff; assists in triaging day-to-day workload; ensures complex regulatory areas are properly handled; and is responsible for overseeing operational and financial activities for the designated team. Serves as a resource to Principal Investigators, Grants Administration, Human Research Protection, and Departments across the Hospital. The Clinical Research Program Manager is an active member of the Partners’ Central Research Management office and is a primary point of contact for Principal Investigators (PIs). The CCRO Program Manager is committed to identifying and adhering to best practices in clinical research while upholding the highest standards of integrity and fiduciary responsibility. The CCRO Program Manager will proactively address the demands of clinical research by providing exceptional customer service to the research community and collaborators in their pioneering efforts in science and medicine. Responsibilities
Oversee multiple clinical research studies, including high-risk gene therapy trials. Hire, train, and supervise Clinical Research Coordinators and Project Managers. Serve as the primary liaison with sponsors, IRBs, core laboratories, site PIs, and study staff. Coordinate trial initiation, patient recruitment, and expedite study start-up and approval processes. Develop and maintain standard operating procedures (SOPs) for assigned projects. Design and implement advertising strategies to support recruitment efforts. Manage study budgets and subcontracts with affiliated institutions. Supervise daily operations of all study staff. Write and maintain operations manuals and case report forms. Participate in policy and procedure development for clinical studies. Coordinate multi-center trials in collaboration with NIH, FDA, and private foundations. Report study progress at investigator meetings. Qualifications
Bachelor's degree required; Master’s Degree or PhD preferred. Experience with gene therapy clinical trials is recommended. Minimum 5 years in a clinical research setting with knowledge of Good Clinical Practice and inherited retinal diseases required. Prior supervisory experience preferred. Strong analytical, communication (written and verbal), quantitative, problem-solving, and organizational skills required. Basic typing and computer skills, including Excel, and medical terminology required. Industry-sponsored and Investigator Initiated clinical trials experience. Attention to detail and ability to work under deadline pressure; ability to interpret information and protocol requirements and initiate appropriate actions. Strong interpersonal and leadership skills with the ability to train, supervise, mentor, and support team members effectively. Excellent judgment and ability to make independent, effective decisions. Team building and conflict management skills; ability to promote collaboration and communication within and beyond the team. Skills/Abilities/Competencies
Project Supervision: Oversees assigned portfolio of Investigators within designated services, ensuring regulatory and study coordinator support is provided. Fosters productive and compliant operations of ongoing research projects. Assists Project Managers in developing, reviewing, and implementing SOPs for approved clinical research protocols. Ensure study assessments, procedures, and enrollment are executed per the study protocol and adhere to regulatory and ethical policies. Assists with training and supervision of Project Managers in writing clinical study protocols and ancillary documents for review by regulatory bodies. Works with Project Managers and Study Coordinators to ensure data integrity and management of study databases. Responsible for ensuring that Study Coordinators maintain up-to-date, accurate, and complete Case Report Forms and other study documents. May participate in Investigators\' Meetings with Sponsors for new and ongoing clinical trials. Training And Oversight
Trains Project Managers and Study Coordinators to promote adherence to protocols and regulatory requirements. Keeps abreast of regulatory changes and ensures team training as necessary. Ensures staff have fulfilled required MEE training and study-specific training requirements. Manages project milestones. Manage and oversee multi-site trial operations including Clinical Coordination, Data Coordination and monitoring oversight. Oversee adherence of FDA trial requirements. Responsible for personnel management and annual performance reviews in concert with the Clinical Research Manager. Financial Responsibilities
Oversees study coordinator responsibilities for patient/subject charges to be debited against clinical study grants and may assist in coordinating billing or budget tasks with oversight from the Clinical Research Manager. Works with Financial Analyst to ensure budget development is on track and compliant with federal regulations. Works with the Agreement Associate to ensure Sponsored agreements are on track and to weigh in on study-specific details affecting contract terms. Ensures staff track time spent on projects. Provides post-award oversight, including a final monthly review of time tracked before charging projects or invoicing Sponsors. Compliance
Ensures the team follows all regulations, including HIPAA and other guidelines, for safety, confidentiality, and study documentation adherence. Maintains regulatory documents, submits adverse event reports, annual reviews, and other reports to IRB, sponsor, and agencies as necessary. Oversees interactions with FDA as applicable. Maintains an active database of all assigned studies within the office. Additional Job Details
Working Conditions: Category I exposure to blood; universal precautions training required for backup support to Study Coordinators. Laptop provided Lifting of 10 to 20 lbs. This is a full-time, onsite role at Mass Eye and Ear Remote Type
Onsite Work Location
325 Cambridge Street Scheduled Weekly Hours
40 Employee Type
Regular Work Shift
Day (United States of America) Pay Range
$62,004.80 - $90,750.40/Annual Grade
7 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. EEO Statement Mass General Brigham Incorporated 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.
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Site: Mass General Brigham Incorporated 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 The Center for Clinical Research Operations (CCRO) provides support across all Mass. Eye and Ear departments conduct clinical research and are structured to meet the education and quality standards for the conduct of clinical research. The position reports to the Associate Director of the CCRO within Research Management. Responsible for direct oversight of Project Managers and Study Coordinators; conducts hands-on training of Project Manager and Study Coordinator staff; assists in triaging day-to-day workload; ensures complex regulatory areas are properly handled; and is responsible for overseeing operational and financial activities for the designated team. Serves as a resource to Principal Investigators, Grants Administration, Human Research Protection, and Departments across the Hospital. The Clinical Research Program Manager is an active member of the Partners’ Central Research Management office and is a primary point of contact for Principal Investigators (PIs). The CCRO Program Manager is committed to identifying and adhering to best practices in clinical research while upholding the highest standards of integrity and fiduciary responsibility. The CCRO Program Manager will proactively address the demands of clinical research by providing exceptional customer service to the research community and collaborators in their pioneering efforts in science and medicine. Responsibilities
Oversee multiple clinical research studies, including high-risk gene therapy trials. Hire, train, and supervise Clinical Research Coordinators and Project Managers. Serve as the primary liaison with sponsors, IRBs, core laboratories, site PIs, and study staff. Coordinate trial initiation, patient recruitment, and expedite study start-up and approval processes. Develop and maintain standard operating procedures (SOPs) for assigned projects. Design and implement advertising strategies to support recruitment efforts. Manage study budgets and subcontracts with affiliated institutions. Supervise daily operations of all study staff. Write and maintain operations manuals and case report forms. Participate in policy and procedure development for clinical studies. Coordinate multi-center trials in collaboration with NIH, FDA, and private foundations. Report study progress at investigator meetings. Qualifications
Bachelor's degree required; Master’s Degree or PhD preferred. Experience with gene therapy clinical trials is recommended. Minimum 5 years in a clinical research setting with knowledge of Good Clinical Practice and inherited retinal diseases required. Prior supervisory experience preferred. Strong analytical, communication (written and verbal), quantitative, problem-solving, and organizational skills required. Basic typing and computer skills, including Excel, and medical terminology required. Industry-sponsored and Investigator Initiated clinical trials experience. Attention to detail and ability to work under deadline pressure; ability to interpret information and protocol requirements and initiate appropriate actions. Strong interpersonal and leadership skills with the ability to train, supervise, mentor, and support team members effectively. Excellent judgment and ability to make independent, effective decisions. Team building and conflict management skills; ability to promote collaboration and communication within and beyond the team. Skills/Abilities/Competencies
Project Supervision: Oversees assigned portfolio of Investigators within designated services, ensuring regulatory and study coordinator support is provided. Fosters productive and compliant operations of ongoing research projects. Assists Project Managers in developing, reviewing, and implementing SOPs for approved clinical research protocols. Ensure study assessments, procedures, and enrollment are executed per the study protocol and adhere to regulatory and ethical policies. Assists with training and supervision of Project Managers in writing clinical study protocols and ancillary documents for review by regulatory bodies. Works with Project Managers and Study Coordinators to ensure data integrity and management of study databases. Responsible for ensuring that Study Coordinators maintain up-to-date, accurate, and complete Case Report Forms and other study documents. May participate in Investigators\' Meetings with Sponsors for new and ongoing clinical trials. Training And Oversight
Trains Project Managers and Study Coordinators to promote adherence to protocols and regulatory requirements. Keeps abreast of regulatory changes and ensures team training as necessary. Ensures staff have fulfilled required MEE training and study-specific training requirements. Manages project milestones. Manage and oversee multi-site trial operations including Clinical Coordination, Data Coordination and monitoring oversight. Oversee adherence of FDA trial requirements. Responsible for personnel management and annual performance reviews in concert with the Clinical Research Manager. Financial Responsibilities
Oversees study coordinator responsibilities for patient/subject charges to be debited against clinical study grants and may assist in coordinating billing or budget tasks with oversight from the Clinical Research Manager. Works with Financial Analyst to ensure budget development is on track and compliant with federal regulations. Works with the Agreement Associate to ensure Sponsored agreements are on track and to weigh in on study-specific details affecting contract terms. Ensures staff track time spent on projects. Provides post-award oversight, including a final monthly review of time tracked before charging projects or invoicing Sponsors. Compliance
Ensures the team follows all regulations, including HIPAA and other guidelines, for safety, confidentiality, and study documentation adherence. Maintains regulatory documents, submits adverse event reports, annual reviews, and other reports to IRB, sponsor, and agencies as necessary. Oversees interactions with FDA as applicable. Maintains an active database of all assigned studies within the office. Additional Job Details
Working Conditions: Category I exposure to blood; universal precautions training required for backup support to Study Coordinators. Laptop provided Lifting of 10 to 20 lbs. This is a full-time, onsite role at Mass Eye and Ear Remote Type
Onsite Work Location
325 Cambridge Street Scheduled Weekly Hours
40 Employee Type
Regular Work Shift
Day (United States of America) Pay Range
$62,004.80 - $90,750.40/Annual Grade
7 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. EEO Statement Mass General Brigham Incorporated 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.
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