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Role Description

We are seeking an experienced clinical research associate to assist with the operations and strategic growth of our clinical research sites. The ideal candidate brings a strong background in clinical research management, regulatory compliance, and team development, with a proven ability to drive operational excellence and foster a culture of quality.

This role requires a proactive, solutions-oriented professional who can balance day-to-day site operations with long-term business development and staff leadership. The successful candidate will ensure compliance with all applicable regulations, assist with study start-up and enrollment efforts, and cultivate an environment where staff thrive, and studies are executed at the highest standards.

How You'll Make An Impact

• Site Operations Management: Assist with daily site activities acting as the primary point of contact for the site, ensuring appropriate staffing, training, and adherence to SOPs. Maintain compliant facilities and equipment.
• Leadership & Staff Development: Assist with training and mentoring research staff. Uphold professional development goals and foster a culture of accountability, integrity, and continuous improvement.
• Work with Manager, Operational Excellence to ensure high staff morale and low turnover rates.
• Regulatory & Compliance Oversight: Promote strict adherence to ICH-GCP, FDA, and local regulations, while maintaining audit readiness across all studies.
• Assist Manager, Operational Excellence, Operational Compliance, and Quality Assurance Departments with all Care Quality and FDA audits.
• Business Development: Support feasibility assessments through partnership with Manager, Operational Excellence to ensure timely responses to questionnaires, and scheduling of site qualification visits.
• Study Start-Up & Enrollment Oversight: Support with regulatory packet submissions, and site initiation processes. Work with investigators to meet or exceed patient recruitment and retention goals.
• Assist with additional projects such as quality improvement initiatives, internal data monitoring ensuring accuracy, integrity, and timely entry of study data, and may represent the site at meetings and industry events.

Qualifications

• A minimum of 5 years of clinical research experience, with at least 1-2 years in a supervisory or management role. CRC experience a plus.
• Hands-on knowledge of ICH-GCP, FDA regulations, and local regulatory requirements.
• Demonstrated success in study management, study start-up, patient recruitment, and compliance oversight.
• Budget management, business development, or sponsor/CRO engagement experience is a strong plus.
• Preferred: Bachelor’s degree in a health sciences field (e.g., Nursing, Biology, Pharmacology, Public Health, or related discipline).
• An equivalent combination of education and direct clinical research leadership experience may be considered in place of formal degrees.

Requirements

• Location: Remote within the United States. This role requires 100% of work to be performed in a remote office environment.
• Travel: This role requires up to 50% travel requirements. Length of travel will depend upon study requirements, staff needs, and company initiatives.
• Type of travel required: National.
• Physical demands associated with this position include:
  • The ability to use keyboards and other computer equipment.
  • Walking - 10%
  • Standing - 10%
  • Sitting - 80%
  • Lifting up to 25 lbs - as needed.
  • Driving - as needed.
• The expected salary range for this role is $70,000 - $100,000 USD per year for full time team members.

Benefits

• Paid Time Off (PTO) and Company Paid Holidays.
• 100% Employer paid medical, dental, and vision insurance plan options.
• Health Savings Account and Flexible Spending Accounts.
• Bi-weekly HSA employer contribution.
• Company paid Short-Term Disability and Long-Term Disability.
• 401(k) Retirement Plan, with Company Match.