As a not-for-profit organization, Mass General Brigham is committed to supporting patient care, research, teaching, and service to the community by leading innovation across our system. Founded by Brigham and Women's Hospital and Massachusetts General Hospital, Mass General Brigham supports a complete continuum of care including community and specialty hospitals, a managed care organization, a physician network, community health centers, home care and other health-related entities. Several of our hospitals are teaching affiliates of Harvard Medical School, and our system is a national leader in biomedical research.
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GENERAL SUMMARY / OVERVIEW The Center for Clinical Research Operations (CCRO) provides support across all Mass. Eye and Ear departments conducting clinical research and is structured to meet the education and quality standards for conduct of clinical research. The position reports to the Associate Director of the CCRO within in 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 responsible for overseeing operational and financial activities for 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. PRINCIPAL DUTIES AND RESPONSIBILITIES Working with their Project Managers and Study Coordinators in supporting the Principal Investigators, of assigned service affiliations, on the full lifecycle of clinical research: from study design, start-up, implementation, and close-out. Responsible for tracking the status of all scientific and feasibility reviews for their team. Supervises day-to-day activities of team members to provide guidance, input, problem solving techniques, and to facilitate growth and professional development.
Qualifications Bachelor of Arts or Science degree required. Minimum 5 years in a clinical research setting with experience and knowledge of Good Clinical Practice guidelines required. Prior supervisory experience preferred. Strong analytical, communication (written and verbal), quantitative, problem solving, and organizational skills required. Basic typing and computer skills including document preparation and excel spreadsheet capabilities, medical terminology required. Industry sponsored and Investigator Initiated clinical trials experience Attention to detail and the ability to work under deadline pressure are essential. Possess ability to interpret information and protocol requirements, and initiate appropriate actions. Strong interpersonal and leadership skills with ability to train, supervise, mentor and support team members effectively Excellent judgment and ability to make independent effective decisions in appropriate situations Team building and conflict management skills. Ability to promote collaboration and communication within and beyond the team.
SKILLS/ABILITIES/COMPETENCIES 1. 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 Standard Operating Procedures for approved clinical research protocols. • Ensure study assessments, procedures and enrollment are executed per the study protocol and adhere to all regulatory and ethical policies. • Assists with the training and supervision of Project Managers in their duties required for the writing of clinical study protocols and ancillary documents (e.g. ICFs, CRFs, recruitment materials) for review by the Human Studies Committee, sponsor (when applicable) and other regulatory bodies. • Works with Project Managers and Study Coordinators to ensure data integrity, including management of any study computer databases. • Responsible for ensuring that Study Coordinators maintain up-to-date, accurate and complete Case Report Forms and other study documents on all study subjects • May participate in Investigatorsʹ Meetings with Sponsors for new and/or ongoing clinical trials.
2. Training and Oversight: • Trains Project Managers and Study Coordinators and all involved personnel to promote adherence to protocols, and regulatory requirements. • Keeps abreast of regulatory changes and ensures their team is updated and trained as necessary. • Ensures study staff and personnel have fulfilled all required MEE training and study specific training requirements. • Responsible for personnel management and annual performance reviews in concert with the Clinical Research Manager.
3. Financial Responsibilities: • Oversees study coordinator responsibilities for patient /subject charges to be debited against clinical study grants and may also assist in coordination of billing or study budgetary tasks with oversight from the Clinical Research Manager. • Works with Financial Analyst to ensure budget development is on track for respective team's studies and to ensure adherence to all Federal regulations and compliance • Works with Agreement Associate to ensure Sponsored agreements are on track and to weigh in on any study specific details that may affect the contract terms. • Ensures that all staff are properly tracking time spent on projects. • Provides post-award oversight including a final monthly review of time tracked by Project Managers and Study Coordinators prior to having the projects charged or the Sponsors invoiced.
4. Compliance: • Responsible for ensuring team is following all regulations, including federal guidelines (HIPAA, OHRP etc), for safety, confidentiality and adherence/compliance of all study documentation. • Ensures that all staff adhere to DHHS guidelines, including maintenance of required regulatory documents, submitting adverse event reports, annual reviews, and other required reports to the IRB, study sponsor, and other agencies as necessary. • Involved in ensuring the Project Managers properly oversee the interactions with Food and Drug Administration (FDA) including applications and other relevant compliance regulations. • Maintain active database of all assigned studies within the office, including incoming and closing projects.
WORKING CONDITIONS Category I: Exposure to blood. Universal Precautions mandatory training required for backup support to Study Coordinators. Laptop provided Lifting of 10 to 20 lbs. SUPERVISORY RESPONSIBILITY Clinical Research Project Managers Clinical Research Coordinators FISCAL RESPONSIBILITY N/A
EEO Statement Mass General Brigham is an Equal Opportunity 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.
Partners Healthcare System Inc. is acting as an Employment Agency in relation to this vacancy.
MGH Institute of Health Professions, founded by Massachusetts General Hospital in 1977, is an innovative and independent graduate school in Boston that is a member of Partners HealthCare. A progressive leader in developing comprehensive models of health care education, the MGH Institute prepares advanced practice professionals in the fields of nursing, physical therapy, occupational therapy and communication sciences and disorders through a distinctive combination of academic study, clinical practice, and research. More than 1,200 students are enrolled in graduate level and certificate programs, with an increasing number of courses available online. The Institute is accredited by the New England Association of Schools and Colleges (NEASC).