Regulatory Coordinator
Topography
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Posted on Friday, April 5, 2024
Topography Health is a first-of-its-kind, physician-focused clinical trials platform. We offer a full stack of tools and services to empower doctors to gather evidence within an existing practice. Our mission is to accelerate clinical research by increasing the investigative capacity of every physician, creating a new world of medicine where patients have seamless access to advanced research. We care deeply about creating data sets that are more inclusive and representative, and we’re determined to change how research is conducted at the community level. We’re backed by Andreessen Horowitz, Bain Capital Ventures, and other great financial and strategic partners.
OVERVIEW
Our Regulatory Coordinators hold a pivotal role, tasked with ensuring that all aspects of or various clinical trials adhere to regulatory requirements. You will manage multiple sites and studies simultaneously, and be responsible for a range of duties, so the ideal candidate will possess a keen attention to detail and meticulous organizational skills, as well as the ability to think critically and problem solve. You will be responsible for regulatory updates, preparing and submitting necessary documentation such as IRB submissions, and maintaining regular communication with study sponsors. You will also provide crucial support and training to clinical research staff, contribute to SOPs for compliance, participate in audits, and review regulatory documents for accuracy and adherence to standards. Additionally, the Regulatory Coordinator will need to be well-versed in regulatory trends and assess the impact of regulatory changes on current and future trials. The role is vital for maintaining integrity of clinical research projects and streamlining processes to prevent delays, improving the efficiency of clinical trials. You will ensure that all trial documentation is thorough and readily available for inspections, fostering smooth operations, effective collaborations, and compliance with all necessary guidelines and procedures.
KEY RESPONSIBILITIES (included but not limited to)
Serve as a liaison between the research team, regulatory authorities, and sponsors
Foster effective communication and collaboration within the internal clinical operations team
Facilitate the submission and training of clinical trial protocols, amendments, and informed consent documents
Manage Institutional Review Board (IRB) communications
Create and maintain regulatory binders and all other essential documents
Facilitate training on all relevant study documents
Regularly collaborate with investigators, sponsors, and Institutional Review Boards (IRBs) to ensure compliance with regulations and protocols
Ensure adherence to all applicable regulatory requirements
Oversee the preparation and submission of regulatory documents to sponsors
Ensure that all records are organized and available for inspection and audit ready at all times
MINIMUM QUALIFICATIONS
Bachelor's Degree or equivalent 4 years of work experience
3+ years of formal work experience in clinical research, including 2+ years of experience in regulatory, specifically in clinical trials
3+ years of experience with Good Clinical Practice (GCP), FDA, and ICH guidelines
3+ years of experience working with electronic document management systems
Ability to work onsite 4+ days a week
PREFERRED QUALIFICATIONS
Certification in Regulatory Affairs
1+ years of experience in IRB
1+ years experience as a CRC
Topography is an equal opportunity employer and does not discriminate based on race, age, religion, gender, gender identity, national origin, citizenship status, sexual orientation, disability, political affiliation, or belief. We are committed to creating an inclusive culture.
This job is no longer accepting applications
See open jobs at Topography.See open jobs similar to "Regulatory Coordinator" BIOS Community.