Regulatory Operations Specialist

Job not on LinkedIn

October 22

Apply Now

Receive Emails with Similar Jobs

CARE

WebsiteLinkedInAll Job Openings

Healthcare Insurance • Education • Recruitment

CARE is a boutique provider of high-quality, accredited carers for the Aged Care and Early Learning industries. It specializes in matching experienced professionals, recent graduates, and students with job vacancies in these sectors, facilitating rewarding career placements. CARE aims to support clients and carers by providing effective staffing solutions and contributing to their success in the industry.

5001 - 10000 employees

Founded 1945

⚕️ Healthcare Insurance

📚 Education

🎯 Recruiter

💰 Grant on 2021-11

📋 Description

• Join our clinical research team as a Specialist, Regulatory Operations in this temporary six-month position. • Oversee and execute all site-level regulatory operational activities for assigned clinical trials in the U.S. • Support regulatory activities for Canadian sites as needed. • Ensure compliance with applicable U.S. regulations and guidelines • Contribute to site start-up activities for U.S. sites when required. • Act as main regulatory operations contact for assigned studies • Support regulatory compliance activities for U.S. clinical research sites, ensuring adherence to FDA, OHRP and global regulatory standards. • Coordinate 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.

🎯 Requirements

• 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. 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. • 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.

🏖️ Benefits

• Competitive salary • Flexible working hours • Professional development budget • Home office setup allowance • Global team events