Clinical Trials Assistant

Description

Job Title: Clinical Trials Assistant

Company Summary:

BioLab Holdings is a regenerative health company focused on providing innovative solutions that encourage the body to heal naturally. Our mission is to raise the standard of caring. Since its founding, BioLab Holdings has experienced explosive growth and is actively developing new technologies to innovate, improve customer experience, and expand its market share within the wound management space. We are seeking individuals who are passionate about making a difference in the work they do and will help support our company's mission.

Reports To: Chief Medical Officer (CMO)

Job Overview: The Clinical Trials Assistant will support the Clinical Affairs department by assisting in the coordination and execution of clinical trials, working closely with Clinical Research Organizations (CROs), product development, marketing, and patient engagement efforts. The assistant will perform various operational and administrative tasks to ensure trials are conducted efficiently and in compliance with regulatory standards. This role is ideal for highly-organized, detail-oriented individuals passionate about contributing to innovative science that improves lives.

Essential Functions:

Document Preparation & Management

• Maintain and organize essential clinical trial documentation (e.g., protocols, informed consent forms, SOPs).
• Assist in the development, review, and distribution of trial materials and regulatory submissions.

Meeting & Visit Coordination

• Schedule and support study meetings.
• Prepare agendas, track action items, and generate meeting minutes.

Communication & Stakeholder Coordination

• Act as a liaison with cross-functional teams including CRO'S, product development, and product marketing
• Coordinate logistics and correspondence, including document translation and safety report tracking.

Clinical Data Support

• Support entry, tracking, and quality control of clinical trial data in EDC and CTMS systems.
• Assist with resolving data discrepancies and monitoring trial progress.

Regulatory Compliance & GCP Adherence

• Ensure trial activities are compliant with ICH-GCP guidelines, FDA/EMA regulations, and company SOPs.
• Participate in audit preparation and archiving study documentation.

Project & Team Support

• Assist in the preparation of presentations, reports, and project tracking tools.
• Support team with investigator payments, trial supplies coordination, and tracking study milestones.

Qualifications

Required:

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, Public Health, or a related field.
• 3-5 years of administrative or coordination experience in clinical research
• Familiarity with clinical trial processes, GCP guidelines, and regulatory documentation.
• Proficiency in Microsoft Office Suite and clinical trial software (e.g., EDC, CTMS).
• Excellent organizational, communication, and time management skills

Preferred:

• Clinical research certification (e.g., ACRP, SoCRA) or coursework in clinical research.
• Knowledge of medical terminology and regenerative medicine/biologics.
• Experience with multi-site or international clinical trials.

* This job description is not intended to be an exhaustive list of all duties, responsibilities, or qualifications associated with the job. Other duties may be assigned.

Location: On-Site - Mesa, AZ

What we offer:

Looking for a company to work for can be a daunting task, but we believe that we stand out from the rest. Our company offers a positive and inclusive work environment, opportunities for growth and development, and a commitment to work-life balance. Join us and become part of a team that values your contributions and invests in your success.

Total Rewards Package:
• Competitive Salaries
• Health, Dental, and Vision Insurance
• Retirement Plans
• Tuition Reimbursement
• Generous Paid Time Off
• Employee Assistance Program
• No premium payments

BioLab Holdings is an Equal Opportunity employer and does not discriminate based on race, ancestry, color, religion, sex, age, marital status, sexual orientation, national origin, medical condition, disability, veteran status, gender identity, or any other basis protected by law.