Project Manager, Research Regulatory Knowledge and Support Program (CTSI) - Res - G&C - CTSI
- Boston, MA, USA
- Employment Type: Full Time
- Shift: Days
- Work Address: 35 Kneeland Street, Boston, MA 02111
- Job Category (for posting purposes): Research
Tufts Tufts Clinical and Translational Science Institute (CTSI) (https://www.tuftsctsi.org/) is one of more than 60 organizations supported by the NIH CTSA program. Established in 2008 to transform the scientific research process through education, collaboration, and research infrastructure services, Tufts CTSI accelerates the translation of laboratory research into clinical investigation, medical practice, and health policy.
Tufts Clinical and Translational Science Institute (CTSI) seeks a Project Manager to support our Regulatory Knowledge and Support (RKS) program. Working in partnership with key stakeholders within and beyond Tufts CTSI to assist with research and education initiatives, the RKS Project Manager will oversee program project management, operations and administrative activities, including helping to develop research protocols; preparing regulatory submissions and amendments; collecting, managing, analyzing, and presenting data and information; documenting polices and procedures; preparing reports and presentations; drafting project plans and coordinating project activities; and overseeing meeting and event logistics. Example projects overseen by the RKS Project Manager include developing and testing improved informed consent forms, establishing research infrastructure to study long-haul COVID locally and nationally with the Clinical and Translational Science Award program, and developing regulatory trainings and a certificate program for diverse members of the research team.
PRINCIPAL DUTIES AND ESSENTIAL FUNCTIONS:
Provision of resources, consultation, and tools to promote participation in clinical and translational research and the inclusion of underrepresented populations in research.
Manage the delivery of research consultations, navigate research teams to relevant resources and services, and assist research teams to overcome barriers and challenges.
In collaboration with program directors, develop clear, actionable timelines and plans to facilitate successful program and project completion. Define project deliverables, set deadlines, and track milestones.
Convene committees or working groups to conduct and complete work
Collect and analyze data to inform strategic decisions and resource allocation and to track program/project progress
Participate in the development of requirements for data systems to meet evolving data and reporting needs. Recommend modifications for process and systems improvement.
Manage meetings, trainings, and events including scheduling and logistical arrangements, serving as liaison to presenters/invitees, agenda preparation, materials distribution, minutes, follow-up, media, and audio-visual needs.
Prepare reports, proposals, and presentations.
Support continual improvement.
Provide excellent internal and external communication.
May supervise one or more support staff.
Maintain collaborative team relationships with peers and colleagues to effectively contribute to the working group’s achievement of goals, and to help foster a positive work environment.
Perform other similar and related duties as required or directed.
Job Knowledge and Skills:
Experience with IRB submissions, knowledge of IRB, informed consent, and Good Clinical Practice (GCP) guidelines, processes, and best practices, absolutely required.
Knowledge of protection of human subjects regulations, Health Insurance Portability and Accountability Act (HIPAA) regulations, FDA regulations, the Code of Federal Regulations (CFR) pertaining to clinical research, and Office of Human Research Protections (OHRP) policies.
Knowledge of clinical research processes.
Outstanding attention to detail, strong organizational skills, the ability to anticipate programmatic needs and manage multiple independent projects simultaneously.
Ability to lead and direct others by setting priorities for completing multiple tasks.
Excellent interpersonal skills to deal effectively with researchers, staff, patients, administrators, auxiliary personnel, regulators, and sponsors.
Excellent writing skills including the ability to draft and present program materials. Some background in grant proposal writing desired.
Keen analytical skills; ability to identify, gather, manage, and synthesize relevant information to support data-driven decisions. Knowledge of REDCap and database management helpful.
Demonstrated knowledge of applying continuous improvement in relevant settings.
Ability to work independently and as a part of a collaborative team.
Comfortable with ambiguity – works to resolve open questions.
Ability to work urgently in a fast-paced and results-oriented environment.
High-energy, proactive, self-starter who will do what is necessary to get the job done.
Proficient with Microsoft Office Suite. Knowledge of database management and statistical packages (SPSS, SAS) helpful.
Knowledge of project management.
Bachelor’s degree required. Master's degree in public health (MPH), healthcare administration (MHA), clinical research, or related fields preferred.
Clinical Research Coordinator or Clinical Research Professional certification preferred.
Minimum of three years’ experience directly related to the duties specified is required.
Experience as a clinical research coordinator or clinical research assistant/associate highly desirable.
An equivalent combination of education and experience, which provides proficiency in the areas of responsibility listed above, may be substituted for the above education and experience requirements.
WORKING CONDITIONS/PHYSICAL DEMANDS:
- Normal office work environment.
- Work requires frequent typing/computer keying, telephone use, and sitting for extended periods.
This is a grant-funded position through April 30, 2023 with the possibility of renewal.
AMERICANS WITH DISABILITIES STATEMENT:
Must be able to perform all essential functions of this position with reasonable accommodation if disabled.
The above statements are intended to describe the general nature and level of work being performed. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified. Tufts Medical Center reserves the right to modify position duties at any time, to reflect process improvements and business necessity.
All your information will be kept confidential according to EEO guidelines.