General Information

Location: Cary, NC, Puyallup, WA

Organization: WCG IRB

Job Type: Full Time - Regular

Description and Requirements

The Manager of IRB Affiars is responsible for the day-to-day leadership of an administrative team. Ensures quality and turn-around time (TAT) expectations are met. Manage, supervise and coordinate medical pre-review including select protocol submissions, review correspondence from the Board and provide support to the IRB Affairs department. This is a “working manager” position.

Bachelor’s degree; or equivalent office management experience in a related industry (Examples: IRB, clinical trials, or regulatory compliance); or equivalent combination of education and experience.

Three or more years performing administrative responsibilities in a fast paced setting
Leadership, mentoring and/or coaching experience required
Demonstrated experience with problem resolution
Demonstrate professionalism in oral and written communication
Skilled in Microsoft Word, Excel, Outlook, Access, and Adobe
Language Skills; Ability to read and interpret documents such as protocols for clinical investigations, medical literature, safety rules, operating and maintenance instructions and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively with customers and employees
Reasoning Ability; Ability to define problems, collect data, establish facts and draw valid conclusions. Ability to interpret an extensive variety of technical instructions and deal with several abstract and concrete variables

Organize and prioritize workflow to meet deadlines and maximize efficiency of the team
Deal effectively with high volumes, deadlines and frequent changes
Responsible for assigning work to staff both verbally and in written form
Review individual as well as group queues in order to prevent delays
Provide timely feedback to staff when errors or training issues are discovered
Evaluate and standardized procedures to improve efficiency of the team
Communicate information and implements new processes and procedures
Communicate with clients (internal and external)
Attend trainings to ensure growth in general management techniques and company-specific knowledge is required
Maintain a positive, customer orientated team environment
Gather, process, analyze, and provide team members with performance numbers throughout the year to include work rate, quality, and attendance
Complete IRB Affairs Assistant tasks, and assists subordinates in performing duties
Supervise Medical Pre-Review department and assist with questions and research of problems and issues
Assist in the preparation of panel reports, unanticipated problems reports, and single patient treatment use protocol submissions
Prepare and maintain routine reports, as directed by supervisor or designee
Coordinate arrangements for meetings and record minutes for staff meetings
Coordinate with members of other departments throughout the organization to resolve issues and ensure that staff and the Board have appropriate information
Produce letters, meeting notices and agendas, reports, schedules and other documents
Train and assist staff in effectively utilizing the Company’s database
Assist in the creation, modification and maintenance of SPI guidelines, desk helps and other forms
Maintain high level of confidentiality and professionalism in dealing with all departmental and personnel issues
Develop, organize, and facilitate training for team when applicable
Interact with HR and manager to evaluate and document personnel issues for team members
Review and approve payroll time sheets and leave/overtime requests
Participate in large- and small-scale special projects

About Us:
For over 50 years, WCG IRB has been at the forefront of protecting the rights and welfare of human subjects during all phases of clinical trials.  Recognized as the gold standard of human subject protection, WCG is the trusted partner to over 1,000 institutions in the United States alone, ranging from small community hospitals and research sites to large academic medical centers and universities. Our unparalleled review ensures that human research studies withstand scrutiny around the world.