Senior Clinical Research Coordinator - Pediatric Oncology
Company: Dana-Farber Cancer Institute
Posted on: May 7, 2022
This Senior Clinical Research Coordinator (Sr. CRC) position
will work within a Pediatric Oncology clinical research program and
support the research team in the overall conduct of clinical
research, including clinical trials, using Good Clinical Practice
under the auspices of the Principal Investigator(s) and the
Clinical and Translational Investigation Program (CTIP). - The
Senior CRC will be responsible for the primary data collection and
management of patient clinical information as it pertains to
participation in clinical research studies. - Ensures timely
collection of protocol related samples including shipment to
outside entities as required. - Maintains regulatory binders and
ensures study compliance with all state, federal, and IRB
requirements. - May be responsible for IRB protocol submissions
(amendments, continuing reviews, and minimal risk protocols). -
This individual may also screen patients for protocol eligibility,
obtain informed consent, and register study participants to
clinical trials. Some travel may be required. 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
- Oversight of the clinical research protocol start-up process
from receipt of protocols through the Pediatric Scientific Review
Committee and IRB submissions, and site activation activities.
- Responsible for data reporting and management, collection of
source documents, use and development of case report forms, adverse
events reporting, filing and archiving of study records, and
resolution of data queries.
- Prepare and or complete regulatory related reports and IRB
submissions. Maintain and organize study regulatory binders, enter
all required study data on an ongoing basis.
- Ensure all study related samples are collected, properly
prepared and shipped according to the protocol requirements and
- Responsible for organizing and preparing for both internal and
external auditing and study monitoring visits.
- Coordination and management of clinical research, including
communication with Sponsors and regulatory authorities.
- Close-out of clinical research protocols, including
contributing to research articles, audit preparation, and
communication with regulatory agencies and other disciplines
- Interact with study participants as directed/required by the
protocol and/or study team.
- May be responsible for tissue sample work.SUPERVISORY
RESPONSIBILITIES:Orients and assists in training new staff.
Provides day-to-day work direction to CRC I and II. -Assists
Clinical Research Managers with completion of performance reviews
and provides input as needed for development and corrective action
activities. PATIENT CONTACT: (Please indicate yes or no. - If yes,
specify what age population served) -May have contact with
Pediatric patients and family members of all ages and populations.
- May distribute protocol schedules, quality of life surveys or
other study-related questionnaires, subject diaries, and/or conduct
follow-up communication with patients and family members.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 and 3-5 years of equivalent
experience required. Experience working in a medical or scientific
research setting or comparable technology orientated business
environment preferred. Performs primary duties with greater
independence and has progressed to performing more advanced skill
sets as directed. -
- Excellent organization and communications skills required.
Strong interpersonal skills - ability to effectively interact with
all levels of staff and externals contacts. Must be detail oriented
and have the ability to follow-through. Ability to effectively
manage time and prioritize workload. Must practice discretion and
adhere to hospital confidentiality guidelines at all times. Must
have computer skills including the use of Microsoft Office. -
- Proficient in understanding of phases of clinical trials.
- Ability to coordinate PI initiated studies.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 , Senior Clinical Research Coordinator - Pediatric Oncology, Healthcare , Brookline, Massachusetts
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