Care Access
Senior Specialist, Regulatory Operations
USA Remote · Senior · Contract
Work authorization required$90k-$100kDetected 4 days ago
GCPComplianceExcelClinical TrialsClinical ResearchFDA RegulatoryResearchCommunicationCollaborationProblem SolvingGxPRegulatory Affairs
About the role
- About Care Access Care Access is working to make the future of health better for all.
- With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care.
- To learn more about Care Access, visit www.CareAccess.com.
Responsibilities
- Provide regulatory advice, lead, execute and deliver regulatory project work
- Support regulatory compliance activities for U.S. clinical research sites, ensuring to adherence to FDA, OHRP and global regulatory standards.
- Develop and implement regulatory strategies to support sites activities
- Support the site(s) through the Site Evaluation Visit, Site Initiation Visit, greenlight to consent, and Study Closeout.
- Supports creation and maintenance of study Delegation of Authority (DOA) logs
- Support regulatory activities throughout the duration of the study lifecycle; 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/ies.
- Oversee regulatory documentation, tracking, and reporting processes to maintain compliance and readiness for regulatory inspections and sponsor audits.
- Oversee and support study close-out activities by ensuring proper archiving and retention of ISF documents.
- Provides guidance and support to site staff with regards to regulatory intelligence and country requirements, including identifying and conducting training.
Requirements
- Ability to communicate and work effectively with a diverse team of professionals
- Minimum of 4 years of experience in operational regulatory affairs within the research site (preferable), or CRO/pharmaceutical industry, with a focus on U.S. regulatory requirements.
- Strong understanding of U.S. regulations and ICH GCP guideline as they relate to site operations
- Excellent knowledge of site-level regulatory requirements for the execution and maintenance of clinical trials in the U.S.
- Reviews and customize, when required, ICFs to ensure compliance with U.S. IRB requirements and site feedback.
Nice to have
- advanced degree preferred or equivalent experience.
Skills
- Strong verbal and written communication skills as evidenced by positive interactions with coworkers, management, clients, and vendors
- Strong computer skills with demonstrated abilities using clinical trials database, MS word and excel
- Experience in electronics Investigator Site Files systems like (Florence, CRIO)
- Ability to balance tasks with competing priorities
- Curiosity and passion to learn, innovate, able to take thoughtful risks and get things done
- 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 and regulatory submissions, including FDA interactions.
- Detail-oriented with strong problem-solving abilities and a proactive approach to regulatory challenges.
- Excellent ability to handle multiple tasks in a fast-paced and constantly changing environment.
- Strong strategic planning, risk management, managing, monitoring and change management skills.
Compensation
- The expected pay range for this role is $90,000 - $100,000 USD per year for full time team members.
Visa & Work Authorization
- Assist in preparing for sponsor monitoring visits and follow up requirements
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This listing is sourced directly from Care Access's careers page and normalized into a canonical job model.