WCG IRB Operations Specialist (Remote)

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
• Paid time off including holidays, vacation, and sick time
• Volunteer Time Off to benefit the community
• Opportunities for career development with on-the-job training, certification assistance, and continuing education reimbursement

Expected hourly rate of pay range: $25.00 to $27.00

GPS level: B3

JOB SUMMARY: Responsibilities include, but are not limited to supporting data collection, the management and analysis of documents, client reporting and problem resolution. This position will:

• Support the Board and clients by preparing documents for review in accordance with company policies and regulatory requirements.
• Provide accurate document identification and data entry.
• Finalize and deliver documents to clients.
• Meet assigned metrics around speed and accuracy.
• Able to deal effectively with high work volume, rigid deadlines, and frequent changes.
• Specific job function requirements are outlined on training curriculum and addenda that supports step level 1 development in this position. Each function is made up of multiple duties. Specific criteria have been attributed to each duty to measure proficiency. As proficiency is proven in each duty, additional duties will be assigned for learning.
• As a remote based staff member, you may be expected to attend onsite new hire training and you may be required to come into the office for training, connection and collaboration with your team or if requested by your manager with reasonable notice.

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.

• Ability to maintain and promote positive working relationships with clients (internal and external) by providing timely and professional service to their needs within the scope of company mission and accompanying regulations.
• Maintain close attention to detail.
• Ability to proof-read and detect errors in typing, spelling, grammar, syntax, and punctuation.
• Ability to read and interpret documents such as protocols for clinical investigations, medical literature, safety rules, operating and maintenance instructions.
• Ability to set priorities and manage time effectively.
• Accurately and completely enter information in a database system.
• Contribute to a positive team environment through collaborative engagement with others.
• Resolve questions and problems effectively.
• Communicate to obtain information or clarify requests.
• Mentor team members by teaching procedures, monitoring, and proofing work, and providing constructive feedback as needed or requested.
• Is able to assist others across Operations, as needed. This may include overtime requests, training support, etc.
• Professional/oral written communication skills.
• Independent worker.
• Accountable for self-metrics.
• Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here.
• Attendance and punctuality are essential functions of the position.
• Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here.

EDUCATION REQUIREMENTS: Bachelors or Associates Degree preferred, or a combination of equivalent education and experience.

CERTIFICATIONS/LICENSE/REGISTRATION REQUIREMENTS: ART certification may be required in advancing in the training step levels. Must keep current by passing the exam every three (3) years. If current with a CIP certification, ART certification is not required.

QUALIFICATIONS/EXPERIENCE:

• Two+ years of experience working in an office setting where proofing documents and attention to detail are essential elements of your job requirements
• Must have strong analytical skills with a high degree of accuracy in work
• Advanced knowledge of Microsoft Word, Excel, Outlook, Databases and Adobe
• Knowledge of FDA regulations as they relate to research (preferred)
• Must be able to maintain confidentiality
• Experience working with medical terminology (preferred)
• Ability to work independently, utilize discretionary judgment, and be a pro-active team player
• Exhibit excellence in:
• Communication – Proficient verbal and written communication skills. Willingness to share and receive information and ideas from all levels of the organization in order to achieve the desired results.
• Customer service- understanding the importance of meeting client requests and adapting to changing needs.
• Teamwork – Commitment to the successful achievement of team and organizational goals through a desire to participate with and help other members of the team

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.

WCG is proud to be an equal opportunity employer – Qualified applicants will receive consideration for employment without regard to race, color, national origin or ancestry, religion or creed, sex, sexual orientation, gender identity, age, marital status, disability, genetic information, citizenship, veteran status, reprisal or any other legally recognized basis or status protected by federal, state or local law.