In-House Clinical Research Associate

About the role

The In‑house Clinical Research Associate (CRA) is an important member of the Alira Health Clinical team. In‑house CRAs manage and support clinical sites from site approval through close‑out, working closely with field CRAs and Clinical Project Managers to ensure the integrity of trial data without frequent travel. The role supports a global, collaborative environment that values courage, accountability, honesty, inclusiveness, and elevating others.

Responsibilities

• Develop study documents and tools, including Informed Consent Form (ICF) templates for local and central IRBs, site binder contents, etc.
• Support sites in obtaining IRB approval, developing submission materials, and creating site‑specific ICFs.
• Respond to sites’ regulatory board requests for protocol and ICF clarification as needed.
• Ensure all required site regulatory documents and approvals are in place prior to investigational product shipment.
• Collect and file regulatory documents appropriately at both the site and in the Trial Master File (TMF); conduct routine file reviews.
• Analyze site performance problems (protocol adherence) and identify solutions; provide ongoing training for study sites.
• Maintain regular communication with study sites to ensure protocol/GCP compliance, assess subject accrual rates, and respond to sponsor requests.
• Conduct remote review of data entered on electronic Case Report Forms (eCRFs).
• Work closely with field CRAs and data management to resolve queries on discrepant data.
• Assist with efforts to recruit investigative sites to participate in clinical studies.
• Comply with ICH GCP guidelines, FDA regulations, and company SOPs.
• Participate in internal, client/sponsor, scientific, and other meetings as required.
• Manage and resolve conflicting priorities to deliver on commitments.
• Perform additional duties as assigned.

Qualifications

• BS/BA from an undergraduate program or equivalent experience.
• 1–2 years of experience in clinical research.
• Permanent authorization to work in the United States.
• Fluent in English (written and verbal).
• Bachelor of Arts (BA) or Bachelor of Science (BS) degree.

Skills

• Careful, thorough, and detail‑oriented.
• Strong organizational skills with the ability to multitask in a fast‑paced environment.
• Analytical, negotiation, meeting management, cross‑functional team, and leadership abilities.
• Self‑starter who thrives in a collaborative, less structured team environment.
• Ability to problem‑solve unstructured or ambiguous challenges.
• Excellent communication and interpersonal skills with a customer‑service orientation.
• Proficient with Microsoft Office Suite, particularly Word and Excel.

Pay

Salary range: $50,000 – $70,000 annually. The final offer will be determined within the applicable location‑specific range and will depend on the candidate’s confirmed work location, relevant experience, skills, qualifications, internal equity, and role scope.