WIRB-Copernicus Group

ABOUT WCG: WCG’s clinical solutions are built on a foundation of best-in-class clinical services companies. We deliver transformational solutions that stimulate growth, foster compliance, and maximize efficiency for those performing clinical trials. WCG is proud to serve individuals on the frontlines of science and medicine, and the organizations striving to develop new products and therapies to improve the quality of human health. It is our role to empower them to accelerate advancement, while ensuring the risks of progress never outweigh the value of human life.

WHY WE LOVE WCG: At WCG, our employees are our most valuable asset, and as with all our assets, we invest in them with an eye toward future success. We provide each eligible employee with a comprehensive set of benefits designed to protect their personal and financial health to help make the most of their future.

• Comprehensive Benefits package - Health, Dental, Vision, Life Disability, 401k with match, and flexible spending accounts
• Employee Assistance Programs and additional work/life resources
• Referral Bonuses and Tuition Reimbursement
• Flexible PTO
• Volunteer Time Off to benefit the community
• Opportunities for career development with on-the-job training, certification assistance, and continuing education reimbursement

The expected base salary range for this position is $52,470-$81,500. This salary range may vary based on the candidate’s qualifications, experience, skills, education, and geographic location.

JOB SUMMARY: The Associate, Compliance & QA (IRB) assists and supports the Compliance team with respect to establishing and maintaining quality assurance standards and measures across WCG services organization and ensuring such standards comply with regulatory requirements and best practice. This position also performs quality process reviews to provide information to management regarding the effectiveness of WCG IRB systems; initiates and facilitates process improvement projects; consults with all staff on matters involving process changes. This position is responsible for working alongside the senior compliance team and WCG employees to ensure the IRB organization remains compliant with WCG’s Quality Management System and business processes.

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.

• Supports the continued development, maintenance, and enforcement of the IRB Quality Management System.
• Assists senior compliance team members to establish and enforce IRB quality standards.
• Assists and supports efforts to implement IRB quality goals, objectives, and process improvements.
• Coaches and trains WCG staff on IRB quality department standards and best practices.
• Engages with WCG IRB staff to author and revise internal standards and associated documents.
• Ensures such standards are in conformity with applicable regulatory agency regulations and guidance.
• Ensures such standards are made available to employees for training.
• Leads assigned work and provides quality oversight regarding the implementation, and/or development, of WCG businesses.
• Ensures the implementation, development, and release of controlled documents to ensure same is performed in line with regulatory agency regulations and guidance, including but not limited to, GxP, GDPR, and HIPAA.
• Initiates and coordinates the periodic review of and/or for-cause changes to written procedures (SOPs and Policies).
• Initiates and/or manages review and posting of desk helps, templates, auto texts, minutes language, COA phrases, and other controlled documents.
• Posts IRB panel rosters internally
• Supports the investigation of subject/third party inquiries.
• Maintains confidentiality in all matters and handles all matters discreetly.
• Researches, investigates, responds to, or clarifies issues or concerns communicated by subjects/third parties.
• Initiates and follows up on communications with the appropriate parties as necessary to aid in the resolution of subject complaints.
• Creates, tracks, and maintains the complaint and record in the database, promptly associating any correspondence sent/received until it is closed (resolved)
• Prepares and maintains routine reports regarding subject inquiries/complaints, as directed by supervisor or designee.
• Coordinates with members of other departments throughout the organization to resolve issues and ensure that staff and the Board have appropriate information.
• Ensures proper investigation of such events is performed, and documentation maintained.
• Supports ISO 9001 certification activities.
• Assists in the preparation of certification documentation in cooperation with appropriate business stakeholders.
• Executes internal audits/periodic reviews of WCG processes and procedures.
• Identifies compliance gaps and provides support and suggestions for remediation.
• Reports status of the quality levels of staff, systems, and production activities for leaders.
• Supports certification reviews and annual surveillance audits.
• Assists with IRB roster management and OHRP/FDA registration.
• Collects updates to IRB roster, reviews, generates and posts courtesy rosters; maintains WCG IRB OHRP/FDA registration.
• Administers ComplianceWire accounts for new community IRB members - this includes creating accounts, assigning curricula, and sending welcome/orientation email to begin use of the system.
• Assists Board members with ComplianceWire account issues.
• Assists/supports the hosting of external audits and inspections including internal audit preparation activities, review of audit report, collection of responses, and follow-up on findings resolution.
• Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here.

EDUCATION REQUIREMENTS:

• Bachelor’s degree or the equivalent combination of education, skills, and experience to perform the job.

CERTIFICATIONS/LICENSE/REGISTRATION REQUIREMENTS:

• Certifications for quality professionals through the Society for Quality Assurance and the American Society for Quality or comparable certifications are desirable. 

QUALIFICATIONS/EXPERIENCE:

• Two (2) to four (4) years’ experience in a quality/regulatory compliance position with evidence of increasing responsibility
• Knowledge of current regulatory and GCP guidelines as they apply to clinical trials.
• Knowledge and understanding of drug development and the clinical trial process.
• Experience in training others in standards and ensuring compliance with employee education and Learning Management Systems (LMS)
• Effective communication (written and oral) skills including strong technical writing skills.
• Demonstrated organizational skills with the ability to work efficiently and independently.
• Excellent interpersonal skills as well as the ability to interact with WCG staff and clients.
• Ability to solve problems and engage in the resolution of conflicts.
• Proficiency with a Learning Management System (LMS) as well as Microsoft Office

SUPERVISORY RESPONSIBILITIES: None

TRAVEL REQUIREMENTS:

Physical and Sensory Requirements: The physical and sensory requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be offered to individuals with disabilities to assist in performing the essential functions of the position. Work activities involve light to moderate physical effort (for example, sitting in one place for extended periods of time, standing, walking, bending, lifting lightweight objects, intermittent to sustained periods of keyboarding). Majority of time is spent in a seated position with frequent opportunity to move about at will. Activities require a variety of easy muscle movements. Work activities involve a frequent need to concentrate on a variety of sensory inputs for moderate to lengthy durations at a time requiring diligence and attention to interpret effectively. There will be a need to attend to single or simultaneous tasks where accuracy of details is important. The need for detailed and precise work is high.