Senior Clinical Research Manager / 40 hrs, day / BWH Surgery
Company: CTI Education Group
Posted on: April 11, 2021
Job Description - Senior Clinical Research Manager / 40 hrs, day
/ BWH Surgery (3142569) Senior Clinical Research Manager / 40 hrs,
day / BWH Surgery - ( 3142569 ) Under general direction from senior
leadership in the Department of Surgery (DOS), the Sr. Clinical
Research Manager will be responsible for providing managerial,
logistical, and administrative direction for investigators,
research assistants, and study coordinators who are involved with
clinical research studies across all divisions.-- The Sr. Clinical
Research Manager will be responsible for overseeing the day-to-day
conduct of clinical research studies to ensure that clinical
research operations are performed in a manner consistent with Mass
General Brigham (MGB), Institutional Review Board (IRB), National
Institutes of Health (NIH) and Food and Drug Administration (FDA)
guidelines. The role includes participating in the development,
implementation, evaluation, and revision of procedures to maximize
efficiency, safety and productivity, and act as a resource for
investigators and study coordinators to assess organizational
factors involved in the implementation of the study including staff
resources, technology, documentation requirements, and practical
aspects involved in the oversight of the study to include the
start-up and close-out phases. The position requires strong
leadership and program development skills. While this is not a
clinical position, it requires a good knowledge of basic clinical
concepts and an understanding of how and when to communicate with
clinicians. The Sr. Clinical Research Manager position requires the
ability to be highly self-directing, resourceful, professional, and
organized. The role will help ensure smooth communication and
follow-up among all staff working on clinical research. The
- Supervise and provide leadership to research personnel, to
include conducting performance reviews, resolving employee issues
impacting work assignments, utilizing the hospital's corrective
action process as appropriate, hiring, training, and allocating
personnel across project teams.
- Coordinate and supervise efforts of clinical research staff
members and provide guidance to the staff in protocol
implementation, meeting recruitment goals, performing clinical
procedures, and managing data collection.
- In conjunction with the investigators, meet with study teams to
review status of all studies and determine new study assignments as
appropriate based on staff experience and current workload.
- Liaise with MGB central offices: Research Management, Human
Research IRB, Clinical Trials Office (CTO), Innovation, Human
Research Quality Improvement (QI) program, Epic eCare research
team, BWH Research Compliance and other BWH and Department groups
on program initiatives to include clinical trials, sponsored
research agreements (SRA), material transfer agreements (MTA) and
data use agreements (DUA).
- Interface with external academic collaborators, as well as
sponsors, clinical sites, and other groups involved in clinical
- Organize, facilitate, and implement operational meetings, DOS
orientations, and research trainings.
- Collaborate with PIs and study teams on new studies to ensure
timely start up including: review study budgets developed by the
CTO; develop other research budgets as needed, in conjunction with
the grants administrators for non-industry studies; assist with the
implementation of new studies, specifically those with IDEs
including communicating with clinical operations teams (Cath Lab,
EP Lab, OR) and Revenue Integrity to ensure compliant and smooth
conduct of new studies.
- Supervise study staff on all aspects of Research Study Billing
Review and reconciliation in Epic and Insight eIRB.
- Serve as a program administrator, working on systems
improvement, program development, and establishment of program
standard operating procedures (SOPs).
- Report to senior leadership on project progress, problems, and
- Implement new initiatives to support the DOS research mission
and goals of excellence.
- Maintain centralized long-term storage account and assist staff
in utilizing centralized long-term research storage resource, and
proper disposal of files.
- Plan and organize a monthly educational meeting for clinical
- Assist with FDA inspections including helping staff prepare for
audits; hosting FDA inspectors for the entirety of their audit
including participating in daily meetings and interviews, providing
requested documentation as needed, leading tours of facilities, and
maintaining detailed account of the inspection; liaising with the
MGB Human Research Committee and the BWH Research Compliance team
as required; managing response to FDA 483 and warning letters; and
implementing corrective action plans including updated SOPs and
training for DOS staff members.
- Oversee payroll through Kronos for all clinical research staff
- In conjunction with the DOS Sr. Lab Administrator, manage all
clinical research space including organization of materials,
seating assignments and workstation needs. Supervisory
- Candidate will supervise approximately 15 full and part-time
clinical research staff members including research
coordinators/assistants and project managers. Fiscal Responsibility
- Assist with research study fund management through invoicing;
tracking payments with sponsors and the MG lockbox; reviewing
expenses; managing clinical research staff member salaries on the
funds in conjunction with the grants administrators; requesting no
cost extensions as needed; and reviewing patient care charges.
- Update salary distribution for clinical research staff members
in conjunction with grants administrators to reflect the studies
they are working on.
- Review Medicare Coverage Analysis on qualifying trials, review
budgets on industry sponsored clinical trials, and assist with the
preparation and review of budgets on all other clinical studies
- Serve as a department contact for research pricing of and
billing mechanism for (global vs. hospital-billed) patient care
- Assist research staff with patient care charge
- Review appropriate channeling of charges through hospital
billing system at the outset of new studies in conjunction with BWH
- Review and approve invoices prior to send out.
- Coordinate with grants administrators on any fund/grant issues
pertaining to clinical research studies.
- Excellent critical thinking skills and ability to work
independently are essential.
- Must be self-motivated, and highly resourceful.
- Excellent verbal and written communication skills.
- Effective analytical and creative problem-solving skills that
support sound decision making, and knowing when to escalate to
leadership, build consensus and facilitate decision making
- Ability to prioritize, delegate, and manage multiple
- Ability to maintain the utmost confidentiality of sensitive and
- Strong computer skills: Proficiency in Word, PowerPoint, Excel
- Strong knowledge of IRB processes and approval mechanisms
included in ongoing IRB oversight; knowledgeable of Good Clinical
Practice (GCP) guidelines.
- Strong knowledge of processes around SRAs, MTAs and DUAs.
- Ability to develop templates, organize technical information,
and maintain functional schedules.
- Ability to educate and conduct training sessions both on
individual and group levels. 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
Keywords: CTI Education Group, Boston , Senior Clinical Research Manager / 40 hrs, day / BWH Surgery, Human Resources , Boston, Massachusetts
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