Senior Specialist, Regulatory Operations

Care Access

2d•$90,000 - $120,000•Remote

About The Position

Care Access is seeking a skilled and experienced Senior Specialist, Regulatory Operations to join our dynamic Global Regulatory Operations Team, part of the Global Expansion and Study Operations department. The Senior Specialist, Regulatory Operations will oversee, support, and execute all site-level regulatory operational activities for assigned clinical trials in the U.S. They may also support regulatory activities for Canadian sites as needed. This role is responsible for ensuring compliance with applicable U.S. regulations and guidelines and may contribute to site start-up activities for U.S. sites when required. You will have an excellent understanding of U.S. regulatory requirements and experience managing regulatory interactions and activities related to clinical research site operations.

Requirements

Ability to communicate and work effectively with a diverse team of professionals
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
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
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 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.
Bachelor's degree in a scientific or healthcare-related field; advanced degree preferred or equivalent experience.
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.
Proven ability to support sites in IRB submissions, regulatory document preparation, and ongoing compliance.

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.
Assist in preparing for sponsor monitoring visits and follow up requirements.
Develop and implement regulatory strategies to support sites activities
Provide regulatory guidance to the site operations teams, ensuring that activities align with current regulations and industry best practices.
Coordinates preparation and review of key site essential records.
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 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.
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 for regulatory inspections and sponsor audits.
Milestones: Tracks and updates the study team accordingly.
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.
Provides guidance and support to site staff with regards to regulatory intelligence and country requirements, including identifying and conducting training.
Collaborate with cross-functional teams, including Quality and Clinical Operations, to ensure regulatory requirements are met.
Monitor and interpret changes in U.S. regulatory policies and guidelines, advising internal stakeholder on potential impacts.
Stay updated on evolving regulations, guidelines, and industry best practices to ensure compliance and adjust strategies.
Identify process gaps, and support the development, implementation, and continuous improvement of new departmental processes.
Support the development, review, and maintenance of departmental Standard Operating Procedures (SOPs), work instructions, and forms
Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.