Project Manager Research - Rosas Lab

Site: The General Hospital Corporation

At Mass General Brigham we know it takes a surprising range of talented professionals to advance our missionfrom doctors nurses business people and tech experts to dedicated researchers and systems analysts. As a notforprofit 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 secondgeneration immigrants veterans and people from different socioeconomic backgrounds to apply.

Job Summary

The Rosas Labs 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.

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 patientoriented 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 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 problemsolve 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

• 5 years of related clinical trials experience strongly preferred. Minimum of 23 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 Description

Onsite

114 16th Street

40

Regular

Day (United States of America)

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 PeopleFocused half PerformanceFocused) 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.