Clinical Research Associate – Full-Service

This is a fully remote position, open to applicants in Arizona, +4 more states.

📋 Description

• Conducts site qualification, initiation, interim monitoring, management activities, and close-out visits (either on-site or remotely) to ensure compliance with regulatory standards, ICH-GCP, Good Pharmacoepidemiology Practice (GPP), and protocol requirements.

• Utilizes judgment and experience to assess the overall performance of the site and its staff, providing recommendations for site-specific actions; promptly communicates/escalates critical issues to the project team and formulates action plans.

• Maintains an up-to-date understanding of ICH/GCP Guidelines or other relevant guidance, applicable regulations, and company SOPs/processes.

• Confirms that the informed consent process has been properly performed and documented for each subject/patient, as necessary.

• Demonstrates commitment to maintaining the confidentiality of each subject/patient.

• Evaluates factors that could impact the safety of subjects/patients and the integrity of clinical data at an investigator/physician site, such as protocol deviations/violations and pharmacovigilance concerns.

• Reviews site processes in accordance with the Clinical Monitoring/Site Management Plan (CMP/SMP).

• Conducts Source Document Reviews of relevant site source documents and medical records.

• Ensures the clinical data entered in the case report form (CRF) is accurate and complete.

• Implements query resolution techniques both remotely and on-site, providing guidance to site staff as necessary, and drives query resolution to completion within established timelines.

• Leverages available hardware and software to facilitate the effective conduct of clinical study data review and collection.

• Ensures site compliance with electronic data capture standards.

• May conduct investigational product (IP) inventory, reconciliation, and assess storage and security procedures.

• Confirms that the IP has been dispensed and administered to subjects/patients in accordance with the protocol.

• Ensures that the investigator/physician site is aware of the need to archive essential documents in compliance with local guidelines and regulations.

• Documents activities through confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents in accordance with SOPs and the Clinical Monitoring Plan/Site Management Plan.

• Aids in subject/patient recruitment, retention, and awareness strategies.

• For assigned tasks, comprehends project scope, budgets, and timelines; oversees site-level activities and communication to ensure project objectives, deliverables, and timelines are achieved.

⛳️ Requirements

• Bachelor’s degree or RN in a relevant field or an equivalent combination of education, training, and experience.

• Familiarity with Good Clinical Practice/ICH Guidelines and other applicable regulatory standards.

• Must possess strong computer skills and be able to adapt to new technologies.

• Exceptional communication, presentation, and interpersonal skills.

• Ability to manage necessary travel of up to 75% regularly.

🏝️ Benefits

• Health benefits including Medical, Dental, and Vision coverage.

• Company-matched 401k.

• Eligibility to take part in the Employee Stock Purchase Plan.

• Flexible paid time off (PTO) and sick leave.