Care Access · 1 week ago
Specialist, Regulatory Operations
United States
Full-time
Remote
Entry, Mid Level
2+ years expCare Access is working to make the future of health better for all. The Specialist, Regulatory Operations will oversee and execute all site-level regulatory operational activities for assigned clinical trials in the U.S., ensuring compliance with applicable U.S. regulations and guidelines.
Clinical TrialsHealth Care
No H1B
Responsibilities
Act as main regulatory operations contact for assigned studies
Support regulatory compliance activities for U.S. clinical research sites, ensuring to adherence to FDA, -OHRP and global regulatory standards
Coordinates preparation and review of key site essential records
Assist in preparing for sponsor monitoring visits and follow up requirements, ensuring compliance and --readiness for assigned studies
Provide regulatory guidance to the site operations teams, ensuring that activities align with current regulations and industry best practices
Review study information and understand start-up timelines, requirements, key contacts, and performance expectations
Track essential records and timelines
Support the site(s) through the Site Evaluation Visit, Site Initiation Visit, greenlight to consent, and Study Closeout
Actively work towards KPIs to help ensure departmental success
Supports creation and maintenance of study Delegation of Authority (DOA) logs
Support regulatory activities throughout the duration of the study life cycle; collaborating with clinical operations teams to ensure regulatory compliance
Coordinate and perform IRB site level submissions and maintenance of approvals throughout the life of the study
Review, and submit high-quality and timely IRB submission materials, including but not limited to protocols, ICFs and marketing materials
Reviews and customize, when required, ICFs to ensure compliance with U.S. IRB requirements and site feedback
Liaise and follow up directly with Sponsor
Ensures accurate compilation, management and tracking of submissions
Oversee regulatory documentation, tracking, and reporting processes to maintain compliance and readiness Ensure timely filing of safety reports, deviations, and amendments/modifications as per study requirements
Ensures that Investigator Site File (ISFs) are completed, up to date, accurate and in compliance with Good Clinical Practice (GCP), regulatory requirements and internal processes
Oversee and support study close-out activities by ensuring proper archiving and retention of ISF documents for regulatory inspections and sponsor audits
Tracks and updates the study team accordingly
Collaborate with cross-functional teams, including Quality and Clinical Operations, to ensure regulatory requirements are met
Identify process gaps, and support the development, implementation, and continuous improvement of new departmental processes
Perform other duties as assigned
Qualification
Required
Bachelor's degree in a scientific or healthcare-related field; advanced degree preferred or equivalent experience
Minimum of 2 years of experience in operational regulatory affairs within the research site (preferable), or CRO/pharmaceutical industry
Understanding of U.S. regulations and ICH GCP guideline as they relate to site operations
Good knowledge of site-level regulatory requirements for the execution and maintenance of clinical trials in the U.S
Proven ability to support sites in IRB submissions, regulatory document preparation, and ongoing compliance
Ability to communicate and work effectively with a diverse team of professionals
Good verbal and written communication skills as evidenced by positive interactions with coworkers, management, clients, and vendors
Work effectively and collaboratively with other team members to accomplish mutual goals
Good computer skills with demonstrated abilities using clinical trials database, MS word and excel
Experience in electronics Investigator Site Files systems like (Florence, CRIO)
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
Demonstrated success in managing IRB submissions
Detail-oriented with good problem-solving abilities and a proactive approach to regulatory challenges
Ability to handle multiple tasks in a fast-paced and constantly changing environment
Benefits
Paid Time Off (PTO) and Company Paid Holidays
100% Employer paid medical, dental, and vision insurance plan options
Health Savings Account and Flexible Spending Accounts
Bi-weekly HSA employer contribution
Company paid Short-Term Disability and Long-Term Disability
401(k) Retirement Plan, with Company Match
Company
Care Access
Care Access helps people learn more about their health and participate in clinical research to help find new medicines and cures.
501-1000 employees
Funding
Current Stage
Late StageTotal Funding
unknownKey Investors
Biomedical Advanced Research and Development Authority (BARDA)
2024-08-26Grant
Leadership Team
Ahmad Namvargolian
CEO, Co-Founder
Recent News
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