Regulatory Compliance Specialist I

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $24 - $28 / hour

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 0%

What it means: how likely this posting is sitting open without active hiring.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

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

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

Upload Resume

Flourish Research

WebsiteLinkedInAll Job Openings

201 - 500 employees

🏥 Healthcare

💊 Pharmaceuticals

Healthcare • Pharmaceuticals

Flourish Research is a national, multi-site clinical trial network and site operator that runs paid clinical studies across the United States. It provides end-to-end clinical research solutions — from first-in-human and early in-patient Phase I studies through Phase II–IV trials — and partners with pharmaceutical sponsors and CROs to accelerate trial execution using wholly-owned sites, experienced investigators, recruitment technology, and access to diverse and underrepresented patient populations. The company operates dozens of clinic locations across many U. S. states, specializes in therapeutic areas including cardiometabolic, oncology, neuroscience, infectious disease and vaccines, and emphasizes patient-centric care, high retention, and regulatory-quality study delivery.

📋 Description

• Prepare, maintain, and provide oversight to all research-related regulatory documents • Populate and coordinate initial regulatory document submissions to the IRB, sponsors, and state or federal regulatory offices as necessary • Compile study information and submit initial, continuing, and final reports to the IRB and/or sponsor • Prepare submission forms and submit updated documents, including amendments, addendums, Investigator’s Brochures, safety information, Form FDA 1572s, and informed consent documents • Accurately file and maintain necessary logs within regulatory binders • Assist in and manage archival of clinical trial documents and records • Prepare for monitoring visits and audits • Manage and update full-time and contract employee curricula vitae and ensure current medical/nursing licenses, certifications, and other required regulatory documents are on file • Abide by HIPAA regulations • Maintain confidentiality of sponsor and Flourish Research trade secrets • Create error-free written documents and reports, including cover letters, notes-to-file, and memos • Seek additional assignments when other tasks are completed • Perform duties in a time- and cost-effective manner • Represent Flourish Research professionally and courteously when interacting with staff, clients, and vendors • Perform additional duties as assigned by management

🎯 Requirements

• Bachelor’s degree or equivalent experience • Minimum of 3 years’ experience within the field of clinical or biological research • Work performed in a typical interior office setting • Local travel required • Monitor/Sponsor/IRB Customer Service • Daily computer use • Occasional evening and weekend work schedules • Ability to properly lift up to twenty-five pounds and occasionally more than twenty-five pounds • Ability to drive and daily availability of an automobile • Exceptional knowledge of clinical research methods • Experience with Microsoft Office applications (Outlook, Word and Excel) and internet-based applications • Detail oriented, organized, self-motivated, able to work independently and on a team, and able to stay on task • Excellent written and verbal communication skills • Moral and ethical decision-making and interactions • Professionalism and strong work ethic • Ability to adapt and take on additional tasks • Problem-solving ability while working closely across departments • Ability to assist with developing and implementing departmental initiatives • Ability to assist with identifying and implementing process improvements • Ability to help achieve department/company goals • Ability to foster relationships across teams • Consistently accomplishes 80% of individual quarterly goals and objectives • Ability to assist with training and mentoring department new hires • Good critical thinking and decision-making skills resulting in sound judgment • Industry certified as applicable • Demonstrated ability to collaborate and align with operations • Flexible and able to multitask and prioritize competing demands • Ability to think independently and influence when appropriate

🏖️ Benefits

• Health, dental, and vision insurance plans • 401(k) with a 100% employer match on the first 4% of employee contributions • Tuition reimbursement • Parental leave • Employee referral program • Employee assistance program • Life insurance • Disability insurance • Generous PTO plan covering vacation, sick, personal days and 8 paid holidays