At Headlands Research, we are building the best clinical trial company in the world. We’re an exceptional family of next-generation clinical trial sites, integrating cutting edge technology and high-quality support services, and significantly expanding participant outreach and participation. Founded in 2018, our company is in high growth mode; we operate 15 clinical trial sites in the US and Canada and have rapid expansion plans.
This new Clinical Study Startup / Regulatory Specialist role will be based in Stockbridge, GA
This opening is for Monday – Thursday and is a full time position.
You can read more about us at headlandsresearch.com.
CRA Headlands/Clinical Research Atlanta is looking for a Study Startup/ Regulatory Specialist. The Study Startup/ Regulatory Specialist manages and executes the site identification process and performs regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements. They prepare and manage site regulatory documentation, reviews and negotiate site regulatory documents with CROs and sponsors, maintain, review, and report on site performance metrics, serve as the primary point of contact for investigative sites, track completion of regulatory documents and establish project timelines. They work with Quality Assurance department to ensure training and regulatory documents are FDA ready at all times.
The ideal candidate has:
● Experience with study startups, clinical trial processes
● Experience with contract management
● Excellent project management skills
● Excellent organizational and time management skills
● Excellent oral communication skills
● Set up and maintain checklists, dashboards, reports, and document templates for new projects.
● Perform quality control reviews of essential site regulatory documents.
● Serve as the primary point of contact for all clinical studies from a regulatory perspective.
● Prepare and maintain regulatory documents from study start up to study end
● Work with study staff (coordinators/recruiters/investigators) to ensure training and documents are in compliance and FDA ready.
● Maintain compliance with all company policies and procedures
● At least 3 years experience in clinical trials as a regulatory person or a clinical coordinator
● Knowledge of regulatory policies/study start-up/maintenance
● Strong critical thinking skills
● Strong ability to multitask
● Strong computer skills; CRIO or electronic source experience a plus
● Ability to communicate clearly and effectively (written and oral)
● Excellent interpersonal and customer service skills
- GCP/Regulatory knowledge