17 days old

IRB Operations Manager

WIRB-Copernicus Group (WCG)

General Information

Location: Remote

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 companys overall mission to protect the rights and welfare of human subjects involved in research.  In addition to the leadership responsibilities, this role may be responsible for processing work based on IRB location and assigned department/team.

-Must have a bachelors degree from an accredited college or university, or an associates degree (AA) with equivalent work experience.

-Current CIP (Certified IRB Professional) certification preferred.
-Certifications such as ART (Advanced Regulatory Training) are required unless a current CIP certification is held. 
-Must commit to passing ART within 18 months of start date and maintain current ART certification.

-Minimum 2 years experience in IRB setting or 3-5 years experience in healthcare industry (life science preferred) in an operational role; Direct work experience with IRB processes, as gained through employment at a respective WCG IRB or another business unit, may be considered in lieu of the work experience requirement.  
-Prior supervisory experience or leading project management work is required. 
-Knowledge of FDA Code of Federal Regulations (21 CFR Parts 50, 56, 312, and 812 and 45 CFR) and ICH Guidelines 
-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
-Ability to work independently; however, be a pro-active team player is required.    
-Ability to proof-read and detect errors in typing, spelling, grammar, syntax and punctuation required.  

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
-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
-Implement performance action plans as well as handle personnel issues including discipline
-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 performance or behavioral issues are discovered
-Work closely with Corporate Trainer/Process Development to provide adequate initial and ongoing training necessary for employees to perform the functions of their job, including leading team-specific orientation and training.
-Evaluate and standardize procedures to improve efficiency of the team
-Communicate information and implement new processes and procedures
-Communicate with Clients (internal and external) and provide outstanding customer service
-Participate in large and smallscale 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 companyspecific knowledge, as required
-Demonstrate proficiency in processing client submissions with minimal errors, including regular participation in the processing of the work within the designated team(s) and meeting the essential duties of the staff-level positions within the designated team(s)
-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
-Other duties as assigned.  These may, on occasion, be unrelated to the position described here.
-Attendance and punctuality are essential functions of the position

SUPERVISORY RESPONSIBILITIES: 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.

To be considered for U.S.-based positions unless currently employed by WCG, where permitted by applicable law (including any applicable reasonable accommodation, medical or religious exemption), candidates must have received or be willing to receive the COVID-19 vaccine by start date.


Posted: 2021-09-08 Expires: 2021-10-14

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IRB Operations Manager

WIRB-Copernicus Group (WCG)

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