Flourish Research

Flourish Research is a top-tier clinical research business advancing society through innovative treatments and promoting diversity.

Food Products

Consumer Staples

251-1K (270)

Founded 2021

2 open positions

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Regulatory Compliance Specialist

4 hours, 59 minutes ago

United States

Full-time

Mid Level

Compliance Manager

Operations

HIPAA

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Flourish Research

Flourish Research is a top-tier clinical research business advancing society through innovative treatments and promoting diversity.

Food Products

251-1K

Founded 2021

View All Jobs 2

Description

Prepare, maintain, and oversee all research-related regulatory documents.
Coordinate initial regulatory document submissions to the IRB, sponsors, and state or federal regulatory offices as needed.
Compile study information and submit initial, continuing, and final reports to the IRB and/or sponsor.
Prepare and submit updated regulatory materials, including amendments, addendums, Investigator’s Brochures, Safety Information, Form FDA 1572s, and informed consent documents.
Accurately file and maintain logs within regulatory binders.
Assist with and manage the archival of clinical trial documents and records.
Prepare for monitoring visits and audits.
Manage and update employee CVs, licenses, certifications, and other required regulatory documents.
Create accurate written documents and reports such as cover letters, notes-to-file, and memos.
Represent the company professionally and courteously with staff, clients, and vendors, and perform additional duties as assigned.

Requirements

Bachelor’s degree or equivalent experience.
Minimum of 3 years of experience in clinical or biological research.
Strong knowledge of clinical research methods.
Experience with Microsoft Office applications, including Outlook, Word, and Excel, as well as internet-based applications.
Must be detail-oriented, organized, self-motivated, and able to work independently and as part of a team.
Excellent written and verbal communication and interpersonal skills.
Ability to adapt, multitask, prioritize competing demands, and take on additional tasks as requested.
Ability to solve problems, think critically, and make sound decisions.
Industry certification as applicable.
Ability to travel locally, use a computer daily, work occasional evenings and weekends, lift up to 25 pounds, and have daily access to an automobile.

Benefits

Competitive pay of $24.00-$28.00 per hour.
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 assistance program.
Life insurance and disability insurance.
Generous PTO plan including vacation, sick time, personal days, and 8 paid holidays.

Interested in this position?

Apply directly on the company website

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