Regulatory Specialist

Summary

Join Care Access as a Regulatory Specialist and oversee all regulatory aspects of assigned clinical trials, ensuring compliance with regulations and supporting startup activities for various sites and studies. You will track essential documents and timelines, handle IRB submissions, maintain centralized document storage, and ensure quality in investigator site files. Responsibilities include supporting sites through evaluation and startup, supporting audits and monitoring visits, reviewing study information, and actively contributing to departmental KPIs. You will liaise with stakeholders, collaborate on new initiatives, and maintain a high level of integrity and professionalism. This remote position requires less than 10% travel.

Requirements

• Ability to communicate and work effectively with a diverse team of professionals
• Strong organizational skills: Able to prioritize, delegate, direct, support, assign and evaluate others work and follow through on assignments
• Communication Skills: Strong verbal and written communication skills as evidenced by positive interactions with coworkers, management, clients, and vendors
• Team Collaboration Skills: Work effectively and collaboratively with other team members to accomplish mutual goals. Bring positive and supportive attitude to achieving these goals
• Strong computer skills with demonstrated abilities using clinical trials database, MS word and excel
• Ability to balance tasks with competing priorities
• Critical thinker and problem solver
• Curiosity and passion to learn, innovate, able to take thoughtful risks and get things done
• Friendly, outgoing personality with the ability to maintain a positive attitude under pressure
• High level of self-motivation and energy
• Ability to work independently in a fast-paced environment with supervision
• Must have a client service mentality
• Bachelor’s Degree or work experience may substitute for required education
• A minimum of 3 year of experience in regulatory; prefer site level

Responsibilities

• Track essential documents and timelines
• Handling submissions to the IRB, management of essential regulatory documents
• Maintain centralized document storage
• Ensure quality is maintained in all investigator site files for assigned studies
• Support sites through their evaluation and begin start-up activities upon selection
• Support the site through the Site Evaluation Visit, Site Initiation Visit, greenlight to consent, and Study Closeout
• Support audits and monitoring visits to ensure regulatory compliance
• Oversee activities throughout the duration of the study; supporting clinical operations teams as required
• Review study information and understand start-up timelines, requirements, key contacts, and performance expectations
• Actively work towards KPIs to help ensure departmental success
• Liaise with key stakeholders across the global organization to communicate needs and establish start-up timelines
• Work with department head on new initiatives and projects to help grow department
• Display high level of integrity and professionalism
• Perform other duties as assigned

Preferred Qualifications

CCRP preferred

Benefits

• PTO/vacation days, sick days, holidays
• 100% paid medical, dental, and vision Insurance. 75% for dependents
• HSA plan
• Short-term disability, long-term disability, and life insurance
• 401k retirement plan