Central Regulatory Specialist

Job Description:

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Promote Javara’s mission with a primary focus on patient safety and well-being, fostering a culture of integrity and excellence.

• Independently manage on-going regulatory activities for multiple clinical research studies across the Javara network.

• Maintain defined file structures in Javara’s e-Regulatory platform and ensure accuracy for on-going studies.

• Update study documents promptly when personnel changes or study amendments occur.

• Upload site documents and IRB approvals to the e-Regulatory platform in a timely manner and notify appropriate teams of updates.

• Review Informed Consent Form (ICF) amendments for consistency with current versions and site language.

• Collaborate with Quality, Finance, and Legal to ensure any ICF changes align with budgets and contracts.

• Communicate proactively with Site Operations to ensure accurate and complete regulatory documents are stored in the e-Regulatory platform at all times.

• Liaise professionally with Sponsors, CROs and IRBs to obtain and document all necessary approvals.

• Provide access for monitors to Javara’s e-Regulatory platform, as requested.

• Take ownership of additional projects as assigned by the Senior Manager of Central Regulatory.

• Adhere to Javara’s Standard Operating Procedures (SOPs), healthcare partner’s SOPs, GCP, and all applicable regulations.

• Obtain and maintain credentialing with Local IRB(s) as needed to assist with submissions and ensure accurate maintenance of regulatory documents.

• Apply critical thinking to resolve regulatory challenges and ensure compliance with evolving requirements.

QUALIFICATIONS:

Required

• Associate’s degree or equivalent combination of education and experience.

• Proficiency in Microsoft Office Suite (Word, Excel, Outlook, Teams, PowerPoint) and ability to use standard office equipment.

• Exceptional time management and organizational skills.

• Excellent written and verbal communication skills, with the ability to communicate clearly across different teams.  

• Strong ability to multi-task and manage multiple priorities while maintaining attention to detail.

• Adaptability to changes in responsibilities and workloads; ability to manage challenging situations and resolve problems effectively.

• Ability to work independently as well as collaboratively with co-workers, peers, supervisors, and external stakeholders.

• Strong problem solving and critical thinking skills; ability to work independently in ambiguous situations and make sound decisions with minimal oversight.

Preferred

• Experience with preparing and filing regulatory documents.

• Familiarity with eTMFs, e-Regulatory Binders, EDCs and other global electronic systems.

• Prior work experience in a related field.

• Bachelor’s degree.

WORK ENVIRONMENT:

This job operates in a professional office setting or remote environment. This role routinely uses standard office equipment such as laptops, phones, photocopiers, and printers.

PHYSICAL DEMANDS:

The physical demands described here are representative of those that must be met to successfully perform the essential functions of this position.  Reasonable accommodation(s) may be made to enable individuals with disabilities to perform the essential functions of this job.

• Regular use of hands to reach, handle or feel objects, tools, or controls; ability to talk and hear.

• Frequent standing, walking, and sitting.

• Occasional lifting and/or moving of up to 25 pounds.

Specific vision abilities required include close vision, distance vision, and the ability to adjust focus.

Javara is an integrated research organization (IRO) that advances value by integrating clinical research within the healthcare ecosystem. Javara brings better outcomes for patient centered care, better economic results, improved access to cutting edge therapies and a more predictable research delivery model to the biopharmaceutical sector.

Equal Employment Opportunity Statement: Javara provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.