Senior Clinical Research Coordinator
Company: Massachusetts General Physicians' Organization
Location: Boston
Posted on: February 25, 2021
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Job Description:
Job Description - Senior Clinical Research Coordinator (3139830)
Senior Clinical Research Coordinator - ( 3139830 ) The REU is a
National Center for Translational Research in Reproduction and
Infertility, funded by the National Institute of Child Health and
Development (NIH). The Unit is also a new recipient of a Gates
Foundation Grand Challenge Award. Dr. Seminara, Unit Chief, is PI
on an NIH Merit Award (R37) which provides 10 years of funding for
her translational studies. Thus, the Unit is securely funded for
the next 10 years and is eager to welcome a staff who are committed
to making the Unit their professional home. As someone who has
passed through the ranks of CRC1 and CRCII, a SCRC candidate will
able to work fairly independently to advance the mission of the
research team. The lists below encompass most of the specific tasks
that a SCRC will be expected to perform. They include Program
Communication and Protocol Design and Execution. However, in any
one of these tasks, there will be day to day challenges that are
unexpected. When a hurdle emerges, a SCRC is expected to take the
next step and trouble shoot the problem. A SCRC must not just "do
their job" but recognize problems, identify solutions and begin to
work toward those solutions. S/he must show flexibility to help
others when help is needed, even if it means re-prioritizing
his/her own work for the day. S/he helps serves as an important
link between project/program managers and the CRC's. The ideal
candidate will possess strong communication skills, have some
experience with strategic planning and be knowledgeable of the
operations of a research unit which includes both PIs and the
Chief. Therefore, even though a SCRC may report directly to a
project or program manager, s/he should expect to engage with the
PIs and the Unit Chief regarding tasks, productivity, and workflow.
In other words, the SCRC should expect that communication is not
siloed within a hierarchical framework but is open and transparent
amongst all members of the Unit. Interested candidates should
submit a cover letter and three references with his/her
application. PRINCIPAL DUTIES AND RESPONSIBILITIES: The SCRC
coordinates and oversees the implementation and activities of
multiple concurrent clinical research studies/trials, with
responsibilities including: Program Communication: -- Collaborate
with all staff and Chief regarding technical and research
developments. -- Strategize with staff when problems arise and
offer solutions. -- Read communication from regulatory agencies (be
they internal or external) and determine which issues require
immediate attention. -- Ensure uniform application of regulatory
requirements across PI/Chief's program as well as other REU
programs. -- Stay abreast of the changing regulatory landscape at
MGB by attending appropriate meetings/councils/etc. -- Communicate
with internal regulatory agencies such as the IRB and the DSMB. --
Help to coordinate new protocol submissions, response to review,
and continuing review with the IRB. -- Help to draft new protocol
submissions, response to review and continuing reviews. -- Ensure
compliance with MGH, IRB, NIH, FDA regulatory requirements and
research goals when drafting regulatory materials. -- Communicate
with hospital staff. -- Communicate with non-Reproductive Endocrine
Unit investigators. -- Follow through on communications. Protocol
Execution and Design: -- Recruit study subjects; -- Assist in
screening; -- Review screening data to determine eligibility; --
Report concerning screening data to the PI; -- Coordinate with
clinical staff; -- Aid with study procedures; -- Perform project
related tasks. These include (but are not limited to) cross
checking of samples and consents, data entry, label making, blood
sample processing, sample packaging and sample mailing. -- Maintain
study documents and enrollment tables; -- Perform data analysis; --
Ensure that all study staff follow GCP procedures and adhere to
safe practices in the conduct of clinical research. 1. Regulatory
Compliance - Develops and maintains protocol specific systems for
Quality Assurance/Quality Control, IRB amendment and reviews, and
external regulatory submissions. These tasks include: -- Update and
verifies accuracy of study forms per protocol; -- Monitor and
report adverse events as required by institutional/federal
regulations; -- Maintain regulatory binders for protocols and INDs;
-- Assist in maintaining and preparing documents and submissions
for INDs; -- Facilitate integration of regulatory issues to ensure
safe practice; -- Develop and maintain systems for QA/QC; --
Contribute protocol recommendations; -- Prepare and submit
protocols, reports and regulatory submissions as required by FDA,
NIH, IRB, MGH subcommittees (Clinical Trials Pharmacy, TCRC) 2.
Data Management - Obtains and organizes patient data from medical
records, physicians, etc., using HIPAA/GCP guidelines: -- Data
entry and analysis; -- Conducts library and internet searches; --
Uses software programs to generate graphs and reports; --
Contributes to development and maintenance of research data,
subject files, and study databases; -- Assists with formal audits
of protocol/INDs. 3. General Support: -- Assists Program and
Administrative Managers with pre-award administrative activities,
such as: -- Compiling and modifying budgets, justifications,
contracts, subcontracts, and MCA's; -- Obtaining and editing
"Biographical Sketches", "Other Support", "Resource & Equipment"
forms, checklists, MGH cover sheets, and other forms, as required
by the sponsor; -- Identifying and resolving any issues regarding
applications prior to submission; -- Training and orienting new
study staff; -- Execute all program operations, including: -- Draft
or review SOPs, training documents, and workflows. -- Ensure that
SOPs are followed. -- Enforce uniform standards for data management
across the Unit. -- Orders clinical research laboratory and office
supplies and manages inventories; -- Oversees bio-tissue sample
processing, per study protocol; -- Maintains sample collection
repository; receives, ships and stores specimens, as required by
protocol; -- Participate in conference calls and other meetings as
directed; -- Perform other duties and responsibilities at the
supervisor's request. QUALIFICATIONS: -- Bachelor's degree
(required); MA/MS/MPH (preferred);-- 2-4 years of research related
experience (required);-- CCRC (preferred)SKILLS/ ABILITIES/
COMPETENCIES REQUIRED: -- Maintain current CITI certification and
has proficient understanding and knowledge regarding GCP;-- High
level time management skills requiring exceptional organizational
skills and the ability to prioritize effectively. This includes the
ability to ask for direction when appropriate and the flexibility
to handle multiple tasks and deadline pressures.-- Extraordinary
attention to detail, ability to work carefully and efficiently with
minimal supervision;-- High level of proficiency with Microsoft
Excel, Word, PowerPoint and computer data entry skills required;--
Experience with medical chart reviews and electronic medical
records;-- Knowledge of database management strongly preferred;--
Clinical knowledge as required for chart reviews;-- Ability to
interpret acceptability of data results;-- Good judgment and
problem solving skills, ability to simultaneously coordinate
multiple tasks, people and schedules;-- Ability to demonstrate
professionalism, compassion and respect for study participants'
rights and needs-- Excellent oral and written communication skills
in English;-- Ability to work both independently and as part of a
busy, multidisciplinary team, interacting with diverse individuals
at multiple levels within the research and clinical group;--
Ability and willingness to learn new research and administrative
skills;-- Work hour flexibility. Some visits start early in the
morning (7 am) and there may be intermittent work after normal
business hours including weekends.WORKING CONDITIONS: Every effort
will be made to keep to traditional work hours of 40 hours per
week. However, the SCRC position is different from the CRCII
position in that work hours are defined by the nature of the work
itself and there is no longer a 40 hour work week limit. Therefore,
a SCRC, at times, may be called upon to come in early, stay late or
work on weekends. For example, evening hours may be needed to
follow-up with study participants by phone and/or meet with staff.
If a SCRC works early, late or on a weekend s/he should not request
to "make up the time" the following week as that is the not the
spirit of the position. (The same expectation holds for project &
program managers, fellows, and faculty.)SUPERVISORY
RESPONSIBILITY:----Will participate in the supervision of clinical
research coordinator I/II, interns, and volunteers.FISCAL
RESPONSIBILITY: Responsible for managing research project and
program material supplies within budgetary guidelines.
Massachusetts General Hospital is an Equal Opportunity Employer. By
embracing diverse skills, perspectives and ideas, we choose to
lead. Applications from--protected veterans and individuals with
disabilities are strongly encouraged. -- Primary Location Work
Locations MGH Main Campus Job Clinical Organization Massachusetts
General Hospital(MGH) Schedule Full-time Standard Hours 40 Shift
Day Job Employee Status Regular
Keywords: Massachusetts General Physicians' Organization, Boston , Senior Clinical Research Coordinator, Healthcare , Boston, Massachusetts
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