Principal Medical Professional

About WCG

WCG delivers transformational solutions that accelerate clinical research and advance human health. We serve the experts, innovators, and pathfinders on the frontlines of science and medicine—empowering them to develop breakthrough therapies while ensuring the risks of progress never outweigh the value of human life. Together, we stimulate growth, maximize efficiency, and shape the future of clinical trials.

Why WCG

At WCG, we invest in our people because you are the driving force behind our mission. When you grow, our impact grows. When you thrive, research accelerates. We empower you to build a meaningful career while advancing the work that improves lives.

What we offer

Comprehensive health and financial protection – Medical, dental, vision, life and disability insurance, 401(k) with company match, and flexible spending accountsResources that support your whole life – Employee assistance programs and work/life balance toolsInvestment in your growth – Referral bonuses, tuition reimbursement, on-the-job training, certification assistance, and continuing education supportTime to recharge – Paid holidays, vacation, and sick timePathways forward – Career development opportunities across One WCG

We practice transparency in everything we do, including compensation. The salary range for this position reflects our commitment to fair, competitive pay based on your qualifications, experience, skills, education, and location. Together, we'll find the right fit for your expertise and our shared mission.

Job Summary

JOB SUMMARY: The Principal Expedited Reviewer provides support as a subject matter expert (SME) for the Expedited team and provides mentoring for the team and Board. The position is responsible for specialized expedited review of human subject research using independent judgment and knowledge of regulations to meet and exceed objectives while contributing to the company’s overall mission to protect the rights and welfare of human subjects involved in research. This requires knowledge of the federal, state, and international laws, regulations, and guidance, including US Good Clinical Practice (GCP), Code of Federal Regulations (CFR) Titles 21 and 45, and International Conference on Harmonization (ICH) Guidelines.

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.

•

Interpret and apply Federal Regulations, Board Standard Practice Instructions [SPI] and Guidelines in a manner to ensure that the Company is in full compliance with all applicable regulations.

•

Review submitted protocols and requests for changes in research (CIR) to determine if they meet the regulatory requirement for an expedited review.

•

May approve protocols or CIR, require modification to the protocol or the CIR in order to approve

•

Will prepare memorandums per guidelines

•

Perform all duties of a Board member and the duties of an Expedited Reviewer

•

Ensure that quality and turn-around time (TAT) expectations are met for assigned work.

•

Delivery customer focused, cost effective and continuously improving products and services.

•

Provide superior customer service to both internal and external clients with inquiries, issues or needs.

•

Consult and advise clients for specific projects per contractual requirements

•

Contribute to expedited team discussions and projects.

PRINCIPAL-LEVEL SKILLS

•

Contribute to high-level reviews such as new protocol, exemption, and/or specialized reviews requiring advanced training and/or degrees.

•

Demonstrate frequent and high-impact contributions in leadership in thought-leadership (leading initiatives and mentoring others) in human subject protection through developing written materials (blog posts, white papers, editorials, journal publications) and presentation at conferences, alone or in collaboration with colleagues.

•

Contribute to continuous improvement projects within and across WCG departments as a subject matter expert on ethical, regulatory, and scientific matters.

•

OTHER DUTIES

•

Contributes to internal audits in collaboration with senior expedited reviewers to ensure compliance with federal guidelines and adherence to internal SOPs.

•

Stay abreast of changes in FDA and OHRP regulations and companywide processes so as to be a reliable resource to other staff and clients.

•

Attendance and punctuality are essential functions of the job

•

Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here.

EDUCATION REQUIREMENTS

•

A bachelor’s degree from a four-year college or university is required. A degree in nursing, biological or chemical sciences is desirable.

CERTIFICATIONS/LICENSE/REGISTRATION REQUIREMENTS

•

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. Mastery of this knowledge is an essential requirement of regulatory review. Principal reviewers must commit to passing the CIP exam within 2 years of reaching the minimum qualification of 2 years with an IRB.

•

Maintain CIP certification once obtained via continuing education or retesting, as required.

QUALIFICATIONS/EXPERIENCE

•

Three (3) years of medical or healthcare related experience is a plus.

•

A basic understanding of medical terminology, diseases and their causes, and standard treatments for the more common diseases is preferred.

•

Subject matter expert with respect to departmental processes

•

Must be able to maintain confidentiality

•

Excellent attention to detail and creative problem-solving abilities.

•

Proven record of working well under pressure on concurrent, multidisciplinary projects.

•

Must be willing to learn guidelines and requirements of applicable Regulatory agencies, Federal Drug Administration (FDA) and the Office for Human Research Protections (OHRP).

•

Ability to read and interpret complex technical documents such as research protocols, consent forms and drug summary information, Federal Regulations and Guidelines, and SOP’s.

•

Self-motivated and assumes ownership of and accountability for assignments and responsibilities.

•

Exhibit excellence in

•

Communication – Proficient verbal/interpersonal and written communication skills. Willingness to share and receive information and ideas from all levels of the organization and clients.

•

Teamwork – Commitment to the successful achievement of team and organizational goals through a desire to participate with and help other members of the team and external vendors

Pay Range

USD $28,000.00 - USD $39,900.00 /Yr.

EEOC Statement

WCG is proud to be an equal opportunity employer – Qualified applicants will receive consideration for employment based on merit and without regard to race, color, national origin or ancestry, religion or creed, sex, sexual orientation, gender expression, gender identity, age, marital status, family or parental status, disability, genetic information, citizenship, veteran status, or any other legally recognized basis or status protected by federal, state, or local law. WCG complies with the Vietnam Era Veterans' Readjustment Act and Section 503 of the Rehabilitation Act. We promote a "One WCG" culture where all are welcome, respected, valued, and empowered to make a difference every day to advance clinical research.