Clinical Research Specialist

About the role

BiVACOR is looking for a highly motivated Clinical Research Specialist to join our team. This role involves overseeing trial sites, managing documentation and data, and serving as a key liaison between BiVACOR and investigational site teams.

Responsibilities

• Serve as key contact for Clinical Site Research Coordinators and liaise to ensure timely, accurate entry of data into the eCRF, including resolution of data queries
• Provide training to study staff on study protocols and GCP guidelines
• Develop and maintain study timelines and budgets
• Develop study documents and procedures, and conduct study site file (eTMF) maintenance reviews
• Review and maintain clinical trial documents (e.g. informed consents) and analyze clinical trial data for accuracy and completeness
• Ensure sites are conducting activities per protocol, HREC requirements, and executed contracts
• Provide frequent communication to study leadership on site status updates
• Work closely with the extended study team, including CROs, vendors, and trial staff
• Follow standard operating procedures and Good Clinical Practice (GCP) guidelines

Requirements

• Bachelor’s degree in a life science-related field; advanced degree may substitute for years of experience
• 2–4 years of experience in a clinical trials research environment or equivalent
• General knowledge of regulatory requirements (e.g. TGA, FDA) and Good Clinical Practices (GCP)
• CCRA, ACRP, CCRP, SOCRA certification or equivalent preferred
• Proficient knowledge of medical terminology and clinical trial documentation requirements, including eTMF management
• Strong interpersonal, collaborative, and time management skills; excellent organizational and communication abilities
• Can-do attitude, detail-oriented and the ability to manage shifting priorities and work across a global team
• Willingness to travel nationally and internationally up to 75% as required to support clinical site activities

Qualifications

• Willingness to travel nationally and internationally up to 75% as required to support clinical site activities

Skills

• Strong interpersonal, collaborative, and time management skills
• Excellent organizational and communication abilities
• Can-do attitude, detail-oriented and the ability to manage shifting priorities and work across a global team

Benefits

BiVACOR offers a competitive compensation package and comprehensive benefits, including:

• 401(k) with company matching
• Medical, dental, and vision insurance
• Health Savings Account (HSA) & Flexible Spending Account (FSA)
• Life insurance & Employee Assistance Program
• Generous paid time off

The expected salary range for this position based in Huntington Beach California is $90,000 to $118,000 annually. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.

This position also qualifies for the benefits detailed at the link provided below.

Relocation benefits are not available for this posting.

Apply today and be part of something extraordinary.

BiVACOR is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.