Massachusetts General Physicians’ Organization
Project Manager, Research
Massachusetts General Physicians’ Organization, Boston, Massachusetts, us, 02298
Job Description - Project Manager, Research (3302436)
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.
Responsibilities
Manage all aspects of the clinical research protocol, including clinical and neuropsychological 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 clinical coordinators/staff and manage assessment of competency for lab members regarding data acquisition and analysis. Establish and monitor safe, compassionate, and excellent practices in clinical research, aiming to provide the highest quality environment for patient-oriented research. 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 troubleshoot and resolve 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, and other clinical assessments as required. Attend weekly clinics and report study progress as appropriate. Regulatory
Provide oversight and advice to Clinical Research staff. Draw on previous clinical research related experience and knowledge of FDA, OHRP regulations as well as GCP and NIH guidelines to participate in the design and implementation of new proposals and projects. 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
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, PowerPoint, RedCap, EPIC. Ability to make decisions independently and/or escalate issues as needed. Ability to seek information and second opinions 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. Leadership and role model capabilities. 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 through 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. Massachusetts General Hospital 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.
#J-18808-Ljbffr
Manage all aspects of the clinical research protocol, including clinical and neuropsychological 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 clinical coordinators/staff and manage assessment of competency for lab members regarding data acquisition and analysis. Establish and monitor safe, compassionate, and excellent practices in clinical research, aiming to provide the highest quality environment for patient-oriented research. 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 troubleshoot and resolve 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, and other clinical assessments as required. Attend weekly clinics and report study progress as appropriate. Regulatory
Provide oversight and advice to Clinical Research staff. Draw on previous clinical research related experience and knowledge of FDA, OHRP regulations as well as GCP and NIH guidelines to participate in the design and implementation of new proposals and projects. 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
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, PowerPoint, RedCap, EPIC. Ability to make decisions independently and/or escalate issues as needed. Ability to seek information and second opinions 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. Leadership and role model capabilities. 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 through 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. Massachusetts General Hospital 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.
#J-18808-Ljbffr