General Information

Location: Puyallup, WA

Organization: WCG IRB

Job Type: Full Time - Regular

Description and Requirements

SUMMARY OF POSITION: Manage and coordinate the daily activities of operations staff assigned to functional teams. Within the scope of this position, this position is responsible for the day to day leadership of a team, ensuring that quality and turn-around time (TAT) expectations are met while contributing to the company’s overall mission to protect the rights and welfare of human subjects involved in research.

EDUCATION REQUIREMENTS:
-Must have a Bachelor’s degree from an accredited college or university, or an Associate’s Degree (AA) with equivalent work experience

CERTIFICATIONS/LICENSE/REGISTRTION REQUIREMENTS:
-Must commit to passing WIRB’s ART exam within 18 months of start date. Maintain ART
certification once obtained by passing the exam every 3 years
-If current with a CIP certification, ART certification is not required

QUALIFICATIONS/EXPERIENCE:
-Minimum 2 years’ experience in IRB setting or 4 years’ experience in healthcare/customer service
industry (life science preferred) in an operational role
-Prior supervisory experience demonstrating leadership expertise required
-Knowledge of FDA Code of Federal Regulations (21 CFR Parts 50, 56, 312, and 812 and 45 CFR) and ICH Guidelines desired but not required
-Experience with medical terminology preferred
-Excellent verbal/written communication skills needed
-Must have advanced computer skills, including MS Word and MS Outlook; Intermediate skills in
Excel and Adobe Acrobat
-Strong interpersonal skills required such as a focus on problem solving, listening objectively and
openly to others’ ideas, and contributing to building a positive team spirit

ESSENTIAL DUTIES/RESPONSIBILITIES: To perform this job successfully, an individual must be able to perform each essential duty and responsibility satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or ability required.
-Display integrity and positive attitude when dealing with employees, management and clients
-Oversee all operational activities, tasks and service to clients to ensure service is being met or
exceeded within company standards
-Deal effectively with high volumes, deadlines and frequent changes; Review individual as well as group queues daily in order to prevent client delays 
-Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Position Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be
construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms.
-Responsible for assigning work to staff; organize and prioritize workflow to meet deadlines and
maximize efficiency of the team
-Direct and supervise activities of Operations staff, which include:
-Lead team to ensure goals and objectives are met or exceeded
-Responsible for obtaining desired results from team
-Gather, process, analyze, and provide team members with performance numbers throughout the year to include work rate, quality, and attendance
-Ensure internal policies and procedures are followed by staff
-Work closely with HR & Training to provide adequate initial and ongoing training necessary for employees to perform the functions of their job
-Review and approve payroll time sheets and leave/overtime requests
-Provide timely feedback to staff when errors or training issues are discovered
-Evaluate and standardize procedures to improve efficiency of the team
-Communicate information and implements new processes and procedures
-Communicate with Clients (internal and external) and provide outstanding customer service
-Participate in large‐ and small‐scale short and long term special projects
-Assist in the development and implementation of Operations Advancement Program
-Attend trainings to ensure growth in general management techniques and company‐specific knowledge, as required
-Demonstrate proficiency in processing client submissions with minimal errors
-Stay abreast of applicable federal regulations governing IRB review of research by attending
seminars, training sessions, professional meetings, and maintaining certifications
-Work as a team with all operational personnel creating and implementing improved processes and policies
-Assist with processing work when necessary to help team achieve goals
-Other duties as assigned. These may, on occasion, be unrelated to the position described here.
-Attendance and punctuality are essential functions of the position
-Overall responsibility of management including direction,
coordination, performance, and evaluation of the assigned team and staff. Responsibilities include training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.