Project Manager, Research
Company: Massachusetts General Physicians' Organization
Location: Boston
Posted on: October 19, 2024
Job Description:
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.
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Keywords: Massachusetts General Physicians' Organization, Providence , Project Manager, Research, Executive , Boston, Rhode Island
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