Senior Clinical Research Associate – Central/West Coast

This is a fully remote position, open to applicants in Arizona, +2 more states.

📋 Description

• Conducts site qualification, initiation, interim monitoring, site management, 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 expertise to assess the overall performance of the site and its staff, providing recommendations for site-specific actions; promptly communicates or escalates significant issues to the project team and formulates action plans.

• Maintains a comprehensive understanding of ICH/GCP Guidelines, relevant regulations, and company SOPs/processes.

• Ensures that the process of obtaining informed consent is properly conducted and documented for each subject/patient as necessary.

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

• Evaluates factors that may impact the safety of subjects/patients and the integrity of clinical data at an investigator/physician site, including 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.

• Confirms that required clinical data entered in the case report form (CRF) is accurate and complete through the review of site source documents and medical records.

• Implements query resolution techniques both remotely and on-site, providing necessary guidance to site staff and ensuring query resolution is achieved within agreed timelines.

• Leverages available hardware and software to facilitate effective clinical study data review and capture.

• Ensures site adherence to electronic data capture standards.

• May handle investigational product (IP) inventory, reconciliation, and assess storage and security measures.

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

• Identifies issues or risks related to blinded or randomized information concerning the IP.

• Applies knowledge of GCP, local regulations, and organizational protocols to ensure that IP is correctly (re)labelled, imported, and managed for return.

• Regularly audits the Investigator Site File (ISF) for accuracy, timeliness, and completeness.

• Reconciles the contents of the ISF with the Trial Master File (TMF).

• Ensures that the investigator/physician site understands the requirements for archiving essential documents in line with local guidelines and regulations.

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

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

• Inputs data into tracking systems as needed to monitor all observations, ongoing status, and assigned action items until resolution.

• Comprehends project scope, budgets, and timelines for personal and team activities; manages site-level communications to ensure project objectives, deliverables, and timelines are achieved.

• Must be capable of quickly adjusting to shifting priorities to meet goals and targets.

• May serve as the primary liaison with project site personnel or collaborate with the Central Monitoring Associate.

• Ensures that all assigned sites and project-specific site team members receive necessary training and comply with applicable requirements.

• Prepares for and participates in Investigator Meetings and/or sponsor face-to-face meetings.

• Engages in, and may lead with supervision, global clinical monitoring/project staff meetings (including Sponsor representation as applicable) and attends clinical training sessions based on project-specific needs.

• Provides support at both site and project levels regarding audit readiness standards and assists in preparing for audits and necessary follow-up actions.

• May offer training or mentorship to junior-level Clinical Research Associates (CRAs).

• May conduct training and sign-off visits for junior CRA staff, as assigned.

⛳️ Requirements

• Bachelor’s degree or RN in a relevant field or a comparable 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 open to adopting new technologies.

• Exceptional communication, presentation, and interpersonal abilities.

• Basic level of critical thinking skills is expected.

• Must be able to manage travel requirements of up to 75% on a regular basis.

🏝️ Benefits

• Comprehensive health benefits, including Medical, Dental, and Vision coverage.

• Company-matched 401k plan.

• Eligibility to participate in the Employee Stock Purchase Plan.

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