IRB Project Coordinator II

The Institutional Review Board (IRB) Coordinator II plays an integral role in the review of human subject research at Drexel University. As a designated reviewer for the IRB, the Coordinator II will participate in, as appropriate, the review and approval process for Full and Expedited applications (Initial and Continuing, Modifications/Amendments, Reportable New Information and Final reports), and Exempt Category projects. The IRB Coordinator II will work with a diverse group of researchers, staff, faculty, students, and with various University committees and offices, such as the General Counsel's Office, Institutional Biosafety Committee, Radiation Safety Committee, and Conflict of Interest Committee. Additionally, the IRB  Coordinator II will foster a culture of compliance, while simultaneously meeting the customer service needs of the Drexel research community.

The IRB Coordinator II will help to prepare and arrange for the research approval activities related to the operation of the IRB throughout the operational and regulatory review process. Activities include creating meeting agendas, review of applications, attendance at Full Convened IRB meetings, preparation of meeting minutes and post-review correspondence. When required the IRB Coordinator II will assist investigators in developing their protocols and informed consent forms by offering expertise in study design, statistics, and the regulations regarding human subject research. The Coordinator II may also develop and present IRB-related trainings that assist the research community such as the submission process and compliance topics.

Essential Functions

IRB Protocol Management Including

• Initial evaluation of IRB correspondence to confirm application completeness

• Perform highly complex duties to facilitate the review and approval process, use of independent judgment in interpreting and applying relevant institutional policies and guidelines.  

• Request additional information from the principal investigators as necessary prior to IRB review.

• Preparation and distribution of IRB review materials in an electronic/paperless manner.

• Assure initial, continuing review and modification reviews of human research protocols are in accordance with Federal, HIPAA, State, local regulations and Institutional policies throughout the review process.

• Formulation of meeting agendas, recording meeting minutes, communicating and corresponding with IRB Chair, IRB members as well as investigators and their staff.

• Entry of compliance related activities and maintenance of IRB Coeus database.

• Manage the compliance database for the appropriate tracking of research projects and generating reports regarding research actions and activities.

Customer Service Including

  • Provide assistance to faculty, staff, and student researchers in preparation of applications.
  • Creating 60 and 30 day expiration notices for investigators.
  • Working with student researchers to educate and support institutional compliance with research submissions.
  • Managing the IRB committee member's document requirements including current training, CVs and IT access to relevant IT platform required for IRB reviews.

Office and Team Development Including:

  • Assist the Director of Human Research Protection in general activities as needed in support of the overall functioning of the office
  • Managing and maintaining compliance requirements to maintain Federal Wide Assurance (FWA) in relation to the IRB
  • Responsible for Oversight of new IRB member training.

Other duties as assigned

 

Required Qualifications

  • High School diploma required
  • A minimum of 1 year of work experience in the role of IRB Coordinator II

Preferred Qualifications

  • Bachelor’s degree in a Health Science related field
  • Strong working knowledge of FDA, OHRP, HIPAA and FERPA regulations and guidelines.
  • Function with minimal supervision and possess excellent communication and analytical skills.
  • Ability to interact with individuals at multiple levels and disciplines.
  • Able to coordinate multiple projects simultaneously.
  • Excellent organizational skills and an ability to independently prioritize work activities.
  • Attention to detail required for reviewing research project applications.
  • Demonstrate competence in database management and high degree of experience working with Microsoft Word, Excel and Outlook.
  • Experience with Coeus and Hyperion database management applications.
  • Ability to exercise sound judgment, function effectively and professionally meeting deadlines.
  • Flexible work schedule, start of workday may vary based upon IRB meeting schedules.
  • Maintain confidentiality of workplace information according to the policies and procedures of the institution.
  • Excellent verbal and written communication skills required

Contact Information

Drexel University

Monet

Harbison

1505 Race Street

Philadelphia, Pennsylvania 19102

2155714821

Background Information

High School

1

  • Non-Profit
  • College/University
  • Institutional Review Board
  • Compliance
  • Administrator or Administrative

None

Target Job Information

Commensura

  • Full Time