Regulatory Specialist

About Valkyrie Clinical Trials and Flourish Research

Valkyrie Clinical Trials (VCT), part of Flourish Research, is a prominent multi-site Oncology clinical research network founded by Dr. David Berz with locations across California and recently in Denver, Colorado. Flourish Research is a leading diversified clinical trial organization specializing in areas such as cardiology, metabolic disorders, renal, oncology, CNS, pulmonology, and vaccines. They emphasize inclusivity, equity, and respect for all employees, patients, and customers, advocating diversity and creating a safe, respectful workplace.

Role Overview

The Regulatory Specialist will provide crucial support at the Denver clinical research site, ensuring compliance and management of regulatory documentation essential for clinical trials.

Key Responsibilities

• Manage preparation and oversight of all regulatory documents related to clinical research.
• Coordinate submissions of initial regulatory paperwork to IRBs, sponsors, and relevant state/federal agencies.
• Compile and submit initial, continuing, and final reports to IRBs or study sponsors.
• Handle submission forms for updates including amendments, addendums, Investigator's Brochures, safety info, FDA forms, and consent documents.
• Maintain accurate regulatory logs and repositories, filing all documents systematically.
• Assist with archiving clinical trial documentation appropriately.
• Prepare for monitoring visits and audits.
• Manage the collection, distribution, and tracking of essential site regulatory documents, including CVs, licenses, and training certificates.
• Keep confidential all study protocols and Protected Health Information.
• Produce error-free documentation such as cover letters, memos, and notes-to-file.
• Perform duties safely and economically, following internal policies.
• Represent Flourish Research professionally when interacting with staff, sponsors, CROs, IRBs, and healthcare personnel.
• Complete additional responsibilities as assigned by management.

Physical and Work Environment Requirements

• Work is conducted primarily indoors in a clinical or office setting.
• Local travel might be necessary.
• Prolonged sitting is required.
• Occasional exposure to call center noise and distractions.
• Extensive computer use expected.
• Some evening and weekend work may be needed.
• Ability to lift up to 35 pounds, occasionally more.
• Daily availability of a vehicle and ability to drive.

Qualifications and Skills

• Minimum of a high school diploma or equivalent; college degree preferred.
• Between one to three years of experience in clinical or biological research.
• Proficiency with Microsoft Office (Outlook, Word, Excel), CTMS systems, eRegs/eDocs, and internet platforms.
• Detail-oriented, organized, self-driven, capable of independent and team work with strong deadline management.
• Excellent written and verbal communication skills.
• Strong ethical judgment and professionalism in interactions with patients, sponsors, IRBs, and colleagues.
• Problem-solving, critical thinking abilities, and adaptability to additional tasks.
• Collaborative approach to cross-departmental problem resolution.
• Contributes to process improvements and supports training of new hires.
• Consistently achieves at least 80% of annual goals.
• Advanced computer skills including Office365 applications.

Compensation and Schedule

This is an on-site, full-time position working Monday through Friday during daytime hours (40 hours weekly). The role is non-exempt with an hourly wage ranging from $34 to $41 depending on experience.

Benefits

• Comprehensive health, dental, and vision insurance options.
• 401(k) plan with full employer match up to 4% employee contributions.
• Tuition reimbursement and parental leave.
• Employee referral and assistance programs.
• Life and disability insurance coverage.
• Generous paid time off including vacation, sick, personal days, and 8 paid holidays.

Diversity and Inclusion

Flourish Research is an equal opportunity employer, committed to making employment decisions based on merit and business needs without discrimination. They comply with laws concerning accommodations for disabilities.