Clinical Research Regulatory Specialist

🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟢 Junior

🧪 Clinical Research

🚫👨‍🎓 No degree required

👻 Ghost score 12%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Rovia Clinical Research

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2007

🏥 Healthcare

🧬 Biotechnology

Healthcare • Biotechnology

Rovia Clinical Research is a U. S. -based network of wholly owned clinical research sites focused on running clinical studies for major pharmaceutical companies, biotechs, and CROs. They emphasize rapid study start-up, reliable enrollment and retention, patient-centered compassionate care, diversity in participant populations, centralized oversight and SOPs for quality and compliance, and direct EMR access through community physician partnerships. Rovia operates multiple sites (17 locations stated) and highlights patient satisfaction, investigator engagement, and partnerships that support fast activation, enrollment targets, and high-quality data delivery.

📋 Description

• Perform startup activities, including IRB submissions, regulatory documentation, vendor access, and training access • Assist with management of Rovia’s Florence eRegulatory platform, including creating study binders, filing startup and maintenance documents, performing quality checks, and monitoring investigator and site credentials • Complete regulatory documentation such as Financial Disclosure Forms, Protocol Signature Pages, FDA 1572s, and Investigative Brochure Signature Pages • Route regulatory documents to research staff and investigators for signatures and follow up as needed • Collaborate with investigators and research staff to complete outstanding documents • Return regulatory documents and credentials to sponsors/CROs in a timely manner • Create and update delegation of authority logs throughout study duration • Create training logs • Review Investigator Site Files for completion and accuracy • Gather documents requested during Site Selection Visits • Create investigator CVs and update them biannually or as requested • Obtain and maintain valid medical licenses for investigators • Participate in development of company SOPs and Guidance Documents • Create and submit continuing reviews, protocol deviations, and other ongoing IRB submissions • Perform other job-related duties as requested or required

🎯 Requirements

• High school diploma required • Bachelor’s degree preferred • 1–2 years of clinical research experience with an emphasis in regulatory and QA • License/certification status with CEUs, as applicable • Current GCP certification • Sound knowledge of medical terminology • Sound knowledge of ICH/GCP, regulatory requirements, FDA and HIPAA policies and practices • Excellent interpersonal skills to interact effectively with clinicians, patients, administrators, auxiliary personnel, regulators, monitors, and sponsors • Meticulous attention to detail • Ability to maintain confidentiality • Strong written communication skills • Strong organizational skills • Proficient in Microsoft Office, Microsoft Excel, and Adobe Acrobat • Ability to meet multiple and changing deadlines • Ability to consult numerous sources for information to prepare documents • Fluent in spoken and written English

🏖️ Benefits

• Supported, valued workplace • Career growth opportunities • Collaborative team environment

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume