The WIRB-Copernicus Group (WCG) Translations Team Lead in Cary, North Carolina
Since 1996, Copernicus Group Independent Review Board® (Copernicus IRB) has been the foremost provider of high-quality ethical review services, focused on the protection of human subject research, during all stages of clinical trials. Renowned for the relentless pursuit of efficiency, Copernicus IRB is incomparably organized to meet the demands of the industry and consistently delivers the most streamlined and highest quality review services to its clients.
The* Translations* *Team Lead *will manage and coordinate the daily activities of Translations teams responsible for securing high quality written translations, which meets client needs, and adhere to IRB standards. Within the scope of this position, contribute to the company’s overall mission to protect the rights and welfare of human subjects involved in clinical research.
- Supervise the work (including priorities and distribution of work load) of Operations Analysts on the Translation team.
- Oversee translation activities and service to clients for assigned research studies to ensure service is being met or exceeded within company standards.
- Ensure the departmental role in maintaining established deadlines and service standards for translation services.
- Direct activities of Translation team:
- Lead team to ensure goals and objectives are met or exceeded
- Ensure internal policies and staff follow procedures
- Implement performance action plans as well as handle personnel issues including discipline.
- Oversee all activities within translations to ensure requests and criteria are correctly and uniformly communicated to sponsors, CROs, and PIs according to company standards
- Periodically evaluate translations services utilized by the company ensuring cost-effectiveness, accuracy, and quality
- Work with fellow Team Leads to manage escalated client issues that arise across departmental team with professionalism and staying within established company policies and procedures
- Work closely with fellow client services team members to ensure all incoming documents are prepared within company policies and procedures and all departmental goals and objectives are achieved
- Stay abreast of applicable federal regulations governing IRB review of research by attending seminars, training sessions, professional meetings, and maintaining certifications
- Bachelor’s degree or equivalent experience
- At least 2 years’ experience in IRB setting, or at least 5 years’ experience in clinical research directly managing the clinical trial process, is required
- Direct work experience with WCG processes, as gained through employment at CGIRB or another business unit, may be used to reduce this work experience requirement
- Experience applying functional knowledge of FDA Code of Federal Regulations (21 CFR Parts 50, 56, 312, and 812 and 45 CFR) and ICH Guidelines required
- Must have advanced knowledge in Microsoft Word, Excel, Outlook and Access
- Current CIP certification preferred
- Must have excellent verbal and written communication skills and possess attention to detail
- Ability to proofread and detect errors in typing, spelling, grammar, syntax and punctuation required
- Medical terminology experience preferred
*We are an Equal Opportunity Employer. Minorities, females, veterans, and individuals with disabilities are encouraged to apply. *
This is a full time-exempt position