At Mass General Brigham, we know it takes a surprising range of talented professionals to advance our mission—from doctors, nurses, business people and tech experts, to dedicated researchers and systems analysts. As a not-for-profit organization, Mass General Brigham is committed to supporting patient care, research, teaching, and service to the community. We place great value on being a diverse, equitable and inclusive organization as we aim to reflect the diversity of the patients we serve.
At Mass General Brigham, we believe a diverse set of backgrounds and lived experiences makes us stronger by challenging our assumptions with new perspectives that can drive revolutionary discoveries in medical innovations in research and patient care. Therefore, we invite and welcome applicants from traditionally underrepresented groups in healthcare — people of color, people with disabilities, LGBTQ community, and/or gender expansive, first and second-generation immigrants, veterans, and people from different socioeconomic backgrounds – to apply.
Job Summary
The Rosas Lab’s Clinical Translational Research Program is hiring a highly motivated individual to help manage our clinical programs. Receiving very general direction from the Principal Investigator, the incumbent will oversee and manage the Down syndrome and Huntington Disease clinical translational programs and clinical trials research. The position requires a comprehensive and detailed understanding of Institutional Review Board (IRB) and clinical research procedures, as well as management skills with a high degree of initiative and independent judgment. The incumbent should demonstrate basic competency for caring for patients with cognitive and behavioral impairment, including impaired decision making capacity. The incumbent should also possess excellent phlebotomy/IV placement skills, prior experience in clinical research and in working with vulnerable populations.
Qualifications
Principal Duties
Manage all aspects of the clinical research protocol, including all clinical and neuropsychological and biomarker assessments; training and supervision of staff; participates in clinical visits; ensures that clinical databases are kept up to date.
Manage all study related documents including new Institutional Review Board protocols and continuing reviews, Investigational New Drug applications, and other regulatory documents related to the clinical protocols.
Interpret and apply GCP and IRB policies to support research compliance.
Coordinate training program for, and oversight of, clinical coordinators/staff and manage assessment of competency for lab members with regards to data acquisition and analysis.
In charge of establishing and monitoring safe, compassionate and excellent practices clinical research, which aims to provide the highest quality environment for performing patient-oriented research with patients suffering from serious neurologic and psychiatric illnesses while maintaining the safest practice standards.
Assist in the preparation for Clinical Trial Monitoring visits and internal/external reviews.
Establish standards for the delivery of research procedures; act as a role model by providing excellent service to internal and external contacts.
Develop, evaluate and standardize operating procedures (SOPs) and effectively troubleshoots and resolves issues.
Supervise and manage staff
Provide a resource for patients and staff
Recruit participants for research protocols
Responsible for clinical study assessments, phlebotomy, infusions, EKGs, other clinical assessments as required
Attends weekly clinics and reports study progress as appropriate.
Regulatory
Provide oversight and advise Clinical Research staff
Draw on previous clinical research related experience and knowledge of FDA, OHRP regulations as well as GCP and NIH guidelines, participate in the design and implementation of new proposals and projects, as appropriate
Assist with IND applications, if needed
Plan and conduct project team meetings
Participate in planning and implementing training opportunities/programs/development of standard operating procedures
Lead in the timely execution of high quality clinical research projects leveraging knowledge, expertise, and risk mitigation.
Build effective, high performance teams via expert communication, decisiveness, prior experience and technical expertise
Lead all activities relating to formal communication with regulatory agencies (FDA, Health Canada, etc), funding agencies (NIH, industry sponsors, foundations, etc) and safety monitoring boards
Troubleshoot study/portfolio related issues and escalate, as appropriate
Assist with generation of reports and preliminary data analyses.
Take on additional tasks and responsibilities, as requested.
Skills/Abilities
Must have formal supervisory experience.
Excellent written and verbal communication skills.
Advanced time management and analytical skills.
Ability to organize information.
Ability to handle sensitive information with absolute confidentiality.
Knowledge of Institutional Review Board applications.
Working knowledge of software applications including Microsoft Word, Excel, Power Point, RedCap, EPIC.
Ability to make decisions independently and/or to escalate issues as needed.
Ability to seek information and second opinion when needed.
Ability to problem-solve, suggest and implement solutions, as needed.
Dependability, perseverance, flexibility and skills as a team player.
Ability to multitask in a challenging environment.
Excellent communication skills.
Leadership. Role Model.
Education
BS degree in health related field.
Nursing degree with nursing licensure preferred.
Experience
Minimum of 2-3 years of clinical research experience, including management of all stages of interventional drug trials from study start up though data lock and study close out.
Supervisory Responsibility
Supervise day to day operations of all study staff. Responsible for training and supervision of new staff.
Liaising with laboratory personnel.
Working Conditions
Day to day operations are performed at the Charlestown Navy Yard, outpatient clinics at MGH and McLean and inpatient units at MGH.
This is a fully onsite position.
Additional Job Details (if applicable)
Additional Job Description
Remote Type
Onsite
Work Location
114 16th Street
Scheduled Weekly Hours
40
Employee Type
Regular
Work Shift
Day (United States of America)
EEO Statement:
The General Hospital Corporation 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.
Mass General Brigham Competency Framework
At Mass General Brigham, our competency framework defines what effective leadership “looks like” by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.