Specialist

Description:

Care Access is seeking a skilled and experienced Specialist, Regulatory Operations to join our dynamic Global Regulatory Operations Team, part of the Global Expansion and Study Operations department.

The Specialist, Regulatory Operations will oversee 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 a good understanding of U.S. regulatory requirements and experience supporting regulatory activities for clinical research sites.

How You'll Make An Impact 

Study-specific regulatory operations:
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.
Milestones: Tracks and updates the study team accordingly
Other Responsibilities
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. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive. 
The Expertise Required

Ability to communicate and work effectively with a diverse team of professionals 
Communication Skills: Good 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 
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.

Certifications/Licenses, Education, And Experience

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.