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 and to help them 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 $82,080 to $127,500. This salary range may vary based on the candidate's qualifications, experience, skills, education, and geographic location.

JOB SUMMARY: The Clinical Reviewer serves as a subject matter expert in clinical, scientific, ethical, and regulatory matters related to human subject research. This role supports the IRB by conducting in‑depth clinical reviews of safety reports, unanticipated problems, complaints, audits, and other submissions requiring regulatory determination, and by providing expert guidance to Board members, staff, and clients. The Clinical Reviewer plays a key role in identifying and resolving complex review issues, communicating Board concerns to investigators and sponsors, contributing to Board deliberations, and advancing human subject protection through research, education, and thought leadership.

ESSENTIAL DUTIES/RESPONSIBILITIES: To perform this job successfully, an individual must be able to perform each essential duty and responsibility satisfactorily.  The accountabilities listed below are representative of the knowledge, skills, and/or ability required.

• Provide primary review of safety reports, unanticipated problem reports, subject complaints, site visit and audit reports, and other documents which require review and regulatory determinations, with a clinical context.
• Identify problems and issues, collect additional information or request corrections, and draft memoranda or decision justifications as necessary.
• When appropriate, present these issues and the clinical context for discussion at board meetings or at staff meetings.
• Provide scientific, ethical and regulatory support and advice to Board members and staff.
• Research, draft, and present reports to the Board on a wide range of topics, including but not limited to, investigator misconduct, site visits, FDA and sponsor audits of investigators and others, issues involving human subjects, sponsors, and institutions.
• Convey the Board’s concerns by composing written correspondence to investigators and sponsors.  This may include requesting additional information and providing the rationale for required changes.
• Identify and assist in the resolution of problematic review items, through interaction with investigators, sponsors and other IRB clients 
• May assist in performance of expedited review of protocols and other submissions, making appropriate decisions on behalf of the Board.

CLIENT SUPPORT

• Advise clients of applicable scientific information and regulations pertaining to human subject research, both orally and in writing.
• Provide guidance to clients to help resolve scientific, ethical and regulatory issues and difficulties.

SCIENTIFIC AND REGULATORY RESEARCH

• Remain current on medical science and regulations pertaining to human subject safety.

OTHER DUTIES

• Consult and advise clients for specific projects per contractual requirements.
• Demonstrate thought-leadership in human subject protection through developing written materials (editorials, journal publications) and presentation at conferences, alone or in collaboration with colleagues
• Review literature and other materials to keep abreast of developments in the regulatory, legal, and ethical arenas.
• Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here.

EDUCATION REQUIREMENTS:

• Scientific degree (example: Registered Nurse, or equivalent)
• Two or more years of clinical experience

CERTIFICATIONS/LICENSE/REGISTRATION REQUIREMENTS:

• Must commit to passing the CIP exam within 2 years of reaching the minimum qualification of 2 years with an IRB. Must maintain CIP certification.

Certified IRB Professional (CIP) - The Certified IRB Professional (CIP®) certification program is for individuals whose primary job responsibilities include substantial participation in overseeing, administering, or performing the daily activities of an IRB as part of an HRPP. The CIP® exam is developed by the CIP® Council and it covers the body of knowledge about human subjects research review under the rules and regulations of the United States.

QUALIFICATIONS/EXPERIENCE:

• Experience applying clinical, scientific, or regulatory judgment in a research or healthcare setting preferred.
• Ability to read, analyze, and interpret common scientific and technical journals, and legal documents.  Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the community.  Ability to write presentations and articles for publication that conform to prescribed style and format.  Ability to effectively present information. 
• Familiarity with mathematical concepts such as probability and statistical inference.  Familiarity with concepts such as common statistical tests, correlation, confidence intervals, and survival curves in discussing the design and interpretation of human subject research.
• Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems.  Ability to deal with a variety of abstract and concrete variables.
• Ability to utilize computers effectively for performance of common office functions. Knowledge of MSWord, MS Excel, MS Outlook and MS Windows.

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.  

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