Senior Clinical Research Manager / 40 hrs, day / BWH Surgery

Company: CTI Education Group
Location: Boston
Posted on: April 11, 2021

Job Description:

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 candidate will:

• 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 research.
• 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 solutions.
• 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 research staff.
• 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 members.
• In conjunction with the DOS Sr. Lab Administrator, manage all clinical research space including organization of materials, seating assignments and workstation needs. Supervisory Responsibility
  • 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 (NIH/foundation/non-profit etc).
    • Serve as a department contact for research pricing of and billing mechanism for (global vs. hospital-billed) patient care charges.
    • Assist research staff with patient care charge reconciliation.
    • Review appropriate channeling of charges through hospital billing system at the outset of new studies in conjunction with BWH Research Compliance.
    • 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 responsibilities.
      • Ability to maintain the utmost confidentiality of sensitive and personal information
      • Strong computer skills: Proficiency in Word, PowerPoint, Excel is essential.
      • 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 strongly encouraged.

Keywords: CTI Education Group, Boston , Senior Clinical Research Manager / 40 hrs, day / BWH Surgery, Human Resources , Boston, Massachusetts