In House Clinical Research Associate

We are looking for an In‑house CRA to manage and support clinical sites from approval through close‑out.

• Develop study documents and tools, including Informed Consent Form (ICF) templates (for both 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.
• Ensure all regulatory documents are collected and filed appropriately at both the site and in the Trial Master File (TMF), conducting 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.

• BS/BA from an undergraduate program or equivalent experience.
• 1‑2 years of experience in clinical research.

• Proven ability to be careful, thorough, and detail‑oriented.
• Strong organizational skills and the ability to multi‑task and work effectively in a fast‑paced environment.
• Strong analytical, negotiation, meeting management, cross‑functional team, and leadership skills.
• Self‑starter who thrives in a collaborative, yet less structured team environment.
• Ability to problem‑solve unstructured or ambiguous challenges.
• Strong command of English, both written and verbal.
• Excellent communication and interpersonal skills with customer service orientation.
• Proficient with MS Office Suite, particularly Word and Excel.
• Permanent authorization to work in the U.S.

Compensation: USD $55,000 - 70,000 commensurate with experience.

English

Bachelor of Arts (BA), Bachelor of Science (BS)

Regular