Research Project Manager II

Job ID : 39940

39940

Location :

450 Brookline Ave, Boston, MA 02215

Category : Clinical Research

Clinical Research

Employment Type : Full time

Full time

Work Location :

Hybrid : 2-3 days onsite / week

Overview

The Zakim Center for Integrative Therapies and Healthy Living is recruiting a Research Project Manager II (RPM II). The RPM I is a critical member of the research team who will work on research projects focused on integrative therapies, such as acupuncture and yoga, and other supportive care, in oncology patients.

The RPM II is responsible for assigned day-to-day coordination and overall management of assigned clinical trials; including multi-center, PI-initiated trials.

Responsibilities include oversight and training of junior study team members, coordinating trial startup and site startup activities, providing training to participating site research staff, regulatory submissions, safety event tracking and reporting, deviation / violation tracking and reporting, participant accrual tracking and reporting, conducting teleconferences, vendor management, coordinating communication with applicable regulatory authorities, etc.

The RPM II will work closely and collaboratively with a variety of faculty and staff at all levels throughout DFCI and our external collaborators.

This position requires clinical research and regulatory experience, as well as excellent project management, analytical, interpersonal, and organizational skills.

The RPM will be supervised and supported by the Zakim Center's Senior Clinical Research Manager. The RPM will assist with the development and implementation of strategies that will ensure compliance, consistency, and accountability in all assigned clinical research activities conducted within the system at DFCI.

The RPM will be responsible to report on defined deliverables, to identify variances in project plan and to develop contingency plans when necessary to keep project milestones on track.

Specific tasks and responsibilities are varied and dependent upon project aims, scope and duration.

Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care.

We are united in our mission of conquering cancer, HIV / AIDS and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations.

We conduct groundbreaking research that advances treatment, we educate tomorrow's physician / researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.

Responsibilities

The Research Project Manager II will work independently under general supervision of the Zakim Center's Senior Clinical Research Manager.

This position may be responsible for some or all of the following :

• Responsible for day-to-day oversight and management of assigned projects.
• Responsible for development and maintenance of regulatory documentation.
• Assists PI with protocol and consent form development for initial application and with subsequent amendment changes.
• Initiates, plans, facilitates and oversees the research project start-up, active and close out phases; for PI Initiated / Multi Center.
• Responsible for Case Report Form design with Sr. CRM and PI directives. Maintain study-related databases and prepare protocol-related reports as needed.
• May be responsible for scheduling research team meetings and conference calls, facilitating mailings and other project-related administrative tasks.
• Responsible for oversight and training of research coordinators and other junior study team members.

In addition to performing the above responsibilities, this position will require the individual to work on an increasingly independent basis with less supervision, and may also be required to :

• Oversee the coordination, execution and overall management of several PI-Initiated / Multi-Center oncology trials.
• Assist senior manager(s) in the development of a project plan that serves as a guiding document that provides overall direction, expectation of deliverables and stated milestones for the participating sites to ensure the success of the project.
• Responsible for assuring that the project team meets all deadlines and is also to maintain an ongoing working relationship with Research team and Principal Investigators.
• Responsible for developing the systems, tools, and infrastructure needed for project management core activities, including study start-up activities, coordinating and managing site activation, research staff training, regulatory submissions, event tracking and reporting, deviation and violation tracking and reporting, participant accrual tracking and reporting.
• Prepares and presents status reports to key stakeholders. Depending on project needs, these reports may include information about project timelines, status of deliverables, and / or resources requirement.

Qualifications

• Bachelor's degree required in a field relevant to clinical research or public health
• 3-4 plus years experience with project management
• Experience working on clinical trials (multi-center, oncology trials perferred).
• Experience in an academic institution and proven history of success in clinical research field is preferred.
• Must have strong knowledge of regulatory affairs, research ethics and the responsible conduct of research.

KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED :

• Ability to perform routine tasks related to the coordination of assigned clinical trials.
• Attention to detail and strong organizational, communication, and interpersonal skills.
• Excellent ability to work independently and balance multiple projects and tasks simultaneously.
• Ability to identify problems or potential obstacles and escalate appropriately.
• Working understanding of DF / HCC SOPs and applicable federal and local regulations / policies.
• Ability to independently perform all primary duties listed above under general supervision.
• Ability to oversee junior study team members.
• Critical thinking skills and an appropriate level of good professional judgment.
• Interest inintegrative therapies research is a plus.

At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong.

As relentless as we are in our mission to reduce the burden of cancer for all, we are equally committed to diversifying our faculty and staff.

Cancer knows no boundaries and when it comes to hiring the most dedicated and diverse professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply.

Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other characteristics protected by law.

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Job ID : 39940

39940

Location :

450 Brookline Ave, Boston, MA 02215

Category : Clinical Research

Clinical Research

Employment Type : Full time

Full time

Work Location :

Hybrid : 2-3 days onsite / week