GENERAL SUMMARY:

The Operations Coordinator (OC) is responsible for providing operational and financial support to the

BWH Center for Clinical Investigation (CCI) for the protocols using CCI services. The OC is responsible for working with the Directors, as well as the Administrative Director to assure success of the activities within the CCI. This position will report directly to the Director of Operation and Operations Manager for the CCI.

Background:

The Center for Clinical Investigation (CCI) is designed to provide infrastructure support to the investigative community, leading to a more effective and robust clinical research enterprise at Brigham and Women's Hospital.

The CCI is comprised of the following services and facilities:

I. Clinical Research Center (CRC)

1. Inpatient Units- A 6-room Standard Bed Unit and a 5-room Intensive Physiologic Monitoring Unit provide space for a broad range of inpatient studies, available to BWH clinical researchers. CCI-funded nurses, technicians, and co-op students staff these units. CCI also supports clinical research activity in the NICU.
2. Outpatient Units- A 5-room outpatient center at 221 Longwood Avenue and a 4-room outpatient center on the 4th floor of the Peter Bent Brigham Building in the main hospital.
3. Processing, Analytical, and Translational Core
   1. Analytical Core Laboratory- Twenty-five research assays are made available to investigators with approved studies.
   2. Processing Core- CCI supports processing space, effort, and supplies for clinical investigators at each site for the Inpatient and Outpatient Cores as well as a special processing service at the Dana-Farber Cancer Institute.
4. Research Coordinator Network (RC Net)
   1. Study Coordinator Pool- Offers investigators experienced study coordinators either full-time for a short period or part-time for an indefinite period.
   2. Research Development Program (RDP)- Direct support for investigators and study staff in preparing and finalizing clinical research study documents for submission to the Institutional Review Board (IRB) and other regulatory groups.
5. Metabolic Phenotyping Core- Provides support for research diets on the inpatient and outpatient units.

II. Education- Training and educational programs for study coordinators, physician investigators, and other clinical research staff members.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Operations

• Protocol Approval Process: Provide administrative support for protocol review and approval process for the CCI Administration. Responsible for tracking and supporting the overall protocol application process and maintaining all documentation.
• Report/Data Collection: Responsible for accurately collecting, tracking, and reporting various data elements throughout the project cycle. Assist in the compilation and preparation of data as requested from internal and external constituents. Work with CCI groups to complete all reporting requirements related to the Harvard Clinical and Translational Science Center.
• Ancillaries Activity: Track the CCI data as it relates to the utilization of CCI Resources
  • Laboratory Ancillaries (Quest, BWH STAT)
  • CCI Summary Digest Management (Cost Estimate)
  • CCI Core Research Services
  • Maintain Pricing Compendium
• Serve as a project coordinator/assistant as needed.

Financial Responsibilities

• Responsible for working with Finance and Operations and the respective grant administrators to ensure that all services are billed appropriately and money is collected for services provided. Execute the creation of all CCI Core Service Invoices across various applications and systems. Assist with the quarterly Accounts Receivable, volume and usage analysis.
• Assist with Payroll timekeeping.
• Serve as a purchasing and accounts payable contact for the CCI.

Marketing Responsibilities

• Facilitate improved methods of communication within the clinical research community via email blasts, website updates, newsletter, and other avenues

Other Administrative Responsibilities

• CRC/CCI Implementation meetings
  • As assigned, manage meetings, agendas, and other related activities for the CCI meetings
• Liaison Role - interface between CCI and PIs. Consult with investigators and study coordinators regarding resource management of CCI funds. BWH point of contact for external Lab vendor, LabCorp.
• In conjunction with the Directors of Finance and Operations, continuously assess and improve the efficiency of systems and processes.
• Obtain a working knowledge of Federal (HIPAA, GCP, FDA, etc), State, and Hospital laws, regulations, and guidelines governing human subject research; attends educational and professional seminars.
• Assure compliance with BWH, JCAHO, NCRR, OSHA, DPH, and state and federal regulations.
• Undertake special projects assigned.
• Perform other duties as assigned.

Qualifications

Qualifications - External

QUALIFICATIONS:

• B.A. or B.S. required.

SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:

• Outstanding interpersonal skills, ability to handle sensitive human resources issues and supervise diverse staff.
• Outstanding organizational skills are necessary to manage many competing timetables and responsibilities. Ability to delegate and plan for the timely and successful completion of short- and long-term objectives.
• Excellent verbal and written communication skills to communicate effectively with a large and diverse constituency.
• Requires the ability to work independently and to accept responsibility for complex and sensitive decision-making as it relates to the overall conduct of the program.
• Interpersonal relationship skills needed to work with many hospital-wide department heads, administrators, and physicians in a positive and collegial fashion.

EEO Statement

BWH is an Affirmative Action Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.