Clinical Trial Associate (Site and Patient Support Specialist)

AOA Dx; Denver (CO); On-site; USD 70,000 - 81,000; Full time

Benefits offered by this job

Unlimited PTO

Monthly healthcare stipend

Life and disability benefits (100%)

401k plan

Job summary

AOA Dx is seeking a Clinical Trial Associate, Site and Patient Support Specialist to provide organized, responsive support across clinical studies and research sites. The role emphasizes agility in a startup environment, handling site activation, document tracking, and cross-functional collaboration with operations, regulatory, and clinical teams.

Responsibilities include serving as the primary contact for sites and patients, maintaining trackers and study files, and escalating risks as needed.

Qualifications

• Experience supporting sponsor-initiated clinical studies, including study startup and site activation
• Experience communicating with research sites, investigators, coordinators, or patients
• Strong organizational, documentation, and follow-up skills with sound judgment on escalation

Responsibilities

• Serve as primary point of contact for research sites, investigators, study coordinators, and vendors
• Support study startup and site activation, including feasibility and qualification
• Maintain study trackers, trial master file, and document decisions and action items
• Coordinate with Clinical Operations, Laboratory Operations, Data Management, Regulatory, Quality, or Medical as needed
• Respond to patient and clinic questions on administrative topics within approved information

Skills

Agility

Organization

Communication

Multitasking

Attention to detail

Education

Bachelor's degree or equivalent

Tools

Microsoft Office

CTMS

eTMF

Job description

AOA Dx is developing the next frontier in early-stage cancer detection through its pioneering work in lipids and proprietary biomarker technology. Our revolutionary tumor marker ganglioside platform, GlycoLocate™, is paving the way for life-saving early cancer detection. In a first of its kind, AOA Dx is developing AKRIVIS GD™, an early-stage liquid biopsy test for ovarian cancer.

Clinical Trial Associate (Site and Patient Support Specialist)

AOA Dx is seeking a Clinical Trial Associate, Site and Patient Support Specialist within Clinical Operations, reporting to the Sr. Director, Clinical Operations, to provide responsive, organized, service-oriented support across our clinical studies and research sites, with a smaller, growing portion of the role supporting patients and clinics as our diagnostic test reaches the market. The most important competency for this role is agility: AOA Dx operates in a startup environment where priorities and responsibilities can shift quickly, and we need someone who adapts fast, stays productive while processes are still being built, and moves work forward independently while knowing when to escalate.

• Serve as the primary, dependable point of contact for research sites, investigators, study coordinators, and vendors, and increasingly for clinics and patients as the diagnostic launches
• Support study startup and site activation, including site identification, outreach, feasibility, and qualification
• Collect, review, organize, and track essential study documents, including IRB submissions, approvals, renewals, contracts, budgets, training records, and activation milestones
• Maintain clinical trackers, study systems, shared files, and the trial master file; schedule study meetings and document decisions, action items, and follow-up
• Build strong working relationships with sites and help them understand study requirements, workflows, timelines, and documentation expectations
• Respond to and track site inquiries and issues, coordinating with Clinical Operations, Laboratory Operations, Data Management, Regulatory, Quality, or Medical as needed
• Monitor outstanding site deliverables and follow up to maintain timelines; support sites through enrollment, study conduct, and closeout; elevate operational gaps, risks, or delays as needed
• Respond to patient and clinic questions on administrative and logistical topics (ordering, specimen collection, shipping, next steps) within approved information, escalating clinical, medical, billing, or privacy questions to the appropriate function
• Take on responsibilities outside a narrowly defined scope, adapting comfortably as study timelines and business needs evolve

Required Qualifications

• Experience supporting sponsor-initiated clinical studies, including study startup and site activation
• Experience communicating directly with research sites, investigators, coordinators, or patients/customers
• Strong organizational, documentation, and follow-up skills, with sound judgment about when to elevate
• Ability to manage multiple priorities and adapt to rapidly changing needs in a startup environment
• Strong attention to detail, with proficiency in Microsoft Office, shared-document platforms, and electronic tracking systems

Preferred Qualifications

• Experience with diagnostic, medical device, biotechnology, laboratory, or women’s health organizations, ideally in a startup or growth-stage company
• Experience with IRB submissions and regulatory document collection
• Experience with CTMS, eTMF, EDC, or customer-support/ticketing systems
• Familiarity with Clinical Practice and applicable clinical research regulations
• Experience in patient services, clinic support, or healthcare customer service

Core Competencies

• Agility and adaptability
• Ownership and accountability
• Site relationship management
• Sound judgment and appropriate escalation
• Organization and attention to detail
• Clear and compassionate communication

Education and Experience

• Bachelor’s degree or equivalent combination of education and experience, plus approximately two or more years in clinical research, clinical operations, study startup, or healthcare operations

Travel Requirements

• Some travel may be required as study and business needs evolve. Reasonable accommodations can be made for individuals with disabilities

Salary Range: $70,200 - $80,800

AOA Dx offers competitive benefits, including unlimited PTO, a monthly healthcare stipend, 100% employee sponsored life and disability benefits, monthly cell phone reimbursement, and a 401k plan.

AOA Dx is an equal opportunity employer committed to a diverse and inclusive workplace. We do not discriminate on the basis of race, color, religion, national or ethnic origin, gender (including pregnancy), sexual orientation or expression, age, disability, veteran status, or any other legally protected characteristic.