Clinical Research Manager - Community Oncology Research Program
Company: Dana-Farber Cancer Institute
Location: Brookline
Posted on: June 20, 2022
|
|
Job Description:
Overview The Community Oncology Research Program Clincial
Research Manager will work within the clinical research program and
manage the research teams located at the DFCI satelite sites in the
overall conduct of clinical trials using Good Clinical Practice
under the auspices of the Principal Investigator and the Clinical
Trials Office. The Community Oncology Research Program (CORP)
Clinical Research Manager, in collaboration with the program's
physicians and research nursing staff, are responsible for the
design, implementation and evaluation of their program's clinical
research activities (therapeutic and non-therapeutic), all related
regulatory and compliance oversight, and direct supervision of
their program's clinical research staff. The CORP Clinical Research
Manager is responsible for tracking and complying with clinical
trial performance benchmarks; e.g. protocol and regulatory
compliance, patient safety, staff development & training and
financial goals, as defined by Senior Research Leadership and the
DFCI Clinical Trials Office. This position is 2-3 days remote. Only
applicants living in Massachusetts, Rhode Island, or New Hampshire
at the time of employment will be considered. 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 Clinical Trials
Operations * Clinical Research Managers (CRM) are responsible for
the oversight of their disease group's clinical trial portfolio and
all related regulatory, compliance and performance metrics
requirements.
* The CRM will oversee the processing of protocols through DFCI
Institutional Review Board (and other institutions' IRBs) when
appropriate. The CRM will collaborate with the DFCI Clinical Trials
Office (CTO), the Office for Human Research Studies (OHRS) and the
Office of Data Quality (ODQ) to fulfill local and federal
requirements governing human clinical trials.
* The CRM will Identify and manage operational, logistical, and
regulatory challenges related to the conduct of clinical trials and
acts as a leader in overseeing their resolution.
* The CRM will work closely with the CORP Project Manager(s) and
the Associate Director in developing the protocol budget, in
collaboration with Research Administration and the Grants and
Contracts offices. Work with grant managers and other financial
managers in the reporting and accounting of these funds.
* Oversees and coordinates the purchase, receipt, inventory and
distribution of equipment utilized in the conduct of clinical
trials.
* Work collaboratively with clinical research administration and
grant managers to help monitor and reconcile all study and related
grant finances as needed.
* The CRM will oversee the subject enrollment, protocol treatment
and follow-up care processes for protocol patients.
* Oversees registration of protocol patients with ODQ, study group
registrar and pharmaceutical company as outlined in protocol.
Regulatory & Compliance * Assumes responsibility for essential
document compliance for entire portfolio. Implements systems to
monitor and ensure regulatory document collection and maintenance
compliance.
* Assumes responsibilities for all clinical trial reporting
requirements; safety event, annual approval, deviations etc.
Implements systems to monitor portfolio compliance.
* Responsible for the disease group's transition from paper to
electronic regulatory binders. Will maintain per DFCI CTO
standards. Data Management & Clinical Trial Monitoring * Assumes
responsibilities for data management and compliance for entire
portfolio. Maintains schedules and procedures necessary for timely
and complete data collection.
* Regularly reports data compliance status to key stakeholders;
i.e. DFCI PI, study Sponsor, DFCI CTO. Implements corrective action
to maintain data compliance when necessary.
* Submits required progress/tracking reports to key stakeholders,
when applicable. Staff Hiring, Supervision, Training & Development
* Responsible for the recruitment and oversight of all of the
research staff. Ensure that all staff complete required mandatory
and ongoing training in a timely manner. Develops and oversees a
program specific on-boarding and orientation process and conducts
annual performance evaluations and competency assessments of
research staff.
* Develops a standard supervision schedule with research staff
including periodic individual and group supervision meeting. Will
develop and agenda, take attendance and document all applicable
meetings.
* Will communicate all personnel concerns to their immediate
supervisor and to DFCI HR partner for the appropriate response and
follow up. Qualifications 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. * Bachelor's Degree required, with a
minimum of 5 + years of related experience, or Master's Degree with
5 years related experience
* Must be able to perform day to day responsibilities independently
with little or no supervision from manager. Has very proficient
knowledge of and ability to execute clinical trials start-up,
active and close out phases. Has very proficient knowledge of
clinical research local policy and federal regulation. Can easily
identify complex regulatory scenarios, independently develops
viable solutions to present to supervisor. Must be very proficient
in the ability to manage personnel issues and to provide critical
feedback to supervisees, when applicable.
* Knowledge of cancer as a disease process, cancer treatment
modalities, and the clinical trial process. In addition has
experience in protocol development, data compilation and analysis.
The Manager will be skilled at developing tracking systems to
ensure timely data management by the clinical research staff. They
will also have expert knowledge of Federal and State regulations as
they relate to research. Strong interpersonal, organizational and
communication skills are required. Must have computer skills
including the use of Microsoft Office and working knowledge of
Livelink; EPIC and Oncore applications. 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 groups as protected by law.
Keywords: Dana-Farber Cancer Institute, Brookline , Clinical Research Manager - Community Oncology Research Program, Healthcare , Brookline, Massachusetts
Click
here to apply!
|