IRB Operations Specialist 1

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Assist the Board and clients by preparing documents for review that comply with company policies and regulatory standards.

• Ensure precise document identification and data entry.

• Finalize and distribute documents to clients.

• Achieve set metrics related to speed and accuracy.

• Aid in data collection, document management and analysis, client reporting, and problem-solving.

• Foster positive working relationships with both internal and external clients by delivering timely and professional service.

• Review documents for typing, spelling, grammar, syntax, and punctuation errors.

• Interpret clinical investigation protocols, medical literature, safety regulations, and operating and maintenance instructions.

• Prioritize tasks and manage time efficiently.

• Address inquiries and issues, communicating to gather information or clarify requests.

• Guide team members by instructing on procedures, reviewing and proofreading their work, and offering constructive feedback.

• Support colleagues across Operations, including handling overtime requests and providing training assistance.

• Uphold confidentiality, self-metrics, attendance, and punctuality.

• Carry out additional duties as assigned by the supervisor.

⛳️ Requirements

• Over two years of experience in an office environment where proofreading documents and attention to detail are critical.

• Strong analytical abilities with a high level of accuracy.

• Advanced proficiency in Microsoft Word, Excel, Outlook, databases, and Adobe applications.

• Familiarity with FDA regulations related to research (preferred).

• Experience with medical terminology (preferred).

• Capability to maintain confidentiality.

• Ability to work autonomously, exercise discretionary judgment, and be an active team participant.

• Excellent verbal and written communication skills.

• Customer service expertise with adaptability to shifting client needs.

• Dedication to teamwork and organizational objectives.

• Capacity to handle a high volume of work, strict deadlines, and frequent changes effectively.

• Skill in proofreading and identifying errors in typing, spelling, grammar, syntax, and punctuation.

• Competence in reading and interpreting clinical investigation protocols, medical literature, safety regulations, and operating and maintenance instructions.

• Ability to accurately and thoroughly enter information into a database system.

• Travel requirement: 0%–5%.

🏝️ Benefits

• Comprehensive benefits package including Health, Dental, Vision, Life Disability, 401k with matching contributions, and flexible spending accounts.

• Employee Assistance Programs and additional work/life resources.

• Referral bonuses.

• Tuition reimbursement.

• Accrued Paid Time Off (PTO).

• Volunteer Time Off to support community involvement.

• Opportunities for career advancement through on-the-job training, certification assistance, and continuing education reimbursement.