Job Overview:
Within the Medical Staff Office, the Medical Staff Coordinator serves as an essential link and resource between senior management, medical staff, and central credentialing office to coordinate the operational processes and ongoing credentialing, privileging, and medical staff governance functions of Organized Medical Staff. Responsible for review, analysis and follow up of credentialing and privileging applications, maintaining strict confidentiality, and ensuring compliance with organizational policies and accrediting and regulatory agencies.
Qualifications:
Required:
- High School Graduate; 2 years of college or Business School
- Matriculating toward Certified IRB Manager (CIM) or Certified IRB Professional (CIP)
- Certification in Human Subject Participant Protection
- Computer knowledge and skills (Microsoft Office, Access and Outlook)
- Must possess strong organizational and communication skills (grammar, punctuation, and sentence structure)
- Clerical experience (typing, word processing, filing)
- Knowledge of medical terminology
- Working knowledge of ProIRB Database
- Working knowledge of ClockWorks (DTR)
Certifications and Licenses Required:
Scheduling Requirements:
- Shifts Monday-Friday 8:30am-4pm
- Full-Time, Days
Essential Functions:
- Based on FDA and OHRP guidelines, determine those actions that can be expedited by the IRB Chairman, or designee, and coordinate review
- Conduct thorough review of financial statements and tracking of all department charges in preparation of department budget
- Coordinate, prepare agenda and attend monthly IRB Subcommittees (IC &SAE) meetings; recording and transcribing minutes
- Coordinate, prepare agenda and meeting packet, distribute and attend monthly IRB meeting recording minutes and transcribing into ProIRB including votes and meeting actions
- Create and maintain files on each study in accordance with FDA and OHRP guidelines
- Create, review and update department policies and procedures as needed
- Day to day management of IRB functions and serving as ex-officio, with vote, on the IRB
- Ensure all paperwork is complete in its entirety before placing on IRB monthly meeting agenda
- Interact with a variety of internal and external contacts, including principal investigators, study coordinators, division/department heads and pharmaceutical sponsors of research
- Maintain accurate employee time and attendance records in Enterprise E-time
- Maintain certification in IRB management in accordance with credentialing organization
- Maintain CV/resume records for all principal investigators, board members and IRB office personnel
- Maintain Human Subject Protection Certification records for all principal investigators, Board members, study coordinators and IRB office personnel
- Maintain ProIRB database with updates from vendor and keep all study records current
- Prepare and mail reminders and forms for studies due for continuing review
- Prepare closed studies for off-site storage in accordance with FDA and OHRP guidelines
- Prepare correspondence that conveys IRB deliberations and contingencies for approval of research activities involving human subjects for the IRB Chairman s signature
- Prepare, review and maintain correspondence and documentation according to FDA/OHRP regulations
- Provide advice and guidance to investigators on FDA, OHRP and institutional regulations, policies and procedures, guidelines and deadlines
- Provide orientation and training to new IRB members
- Research and answer questions raised by the Board, sponsors, principal investigators or hospital employees
- Screen new and continuing review applications for completeness
- Serve as a resource for staff, investigators and IRB members on issues regarding the protection of human subjects.
Other Duties:
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Benefits and Perks:
At RWJBarnabas Health, our market-competitive Total Rewards package provides comprehensive benefits and resources to support our employees physical, emotional, social, and financial health.
Paid Time Off (PTO)
Medical and Prescription Drug Insurance
Dental and Vision Insurance
Retirement Plans
Short & Long Term Disability
Life & Accidental Death Insurance
Tuition Reimbursement
Health Care/Dependent Care Flexible Spending Accounts
Wellness Programs
Voluntary Benefits (e.g., Pet Insurance)
Discounts Through our Partners such as NJ Devils, NJ PAC, Verizon, and more!
Equal Opportunity Employer
