Senior Clinical Research Associate - Endocrinology

Job Summary

The Clinical Research Associate (CRA) will perform monitoring and site management activities for Phase I-IV clinical research projects to assess the progress of clinical projects at assigned sites (either on site or remotely) and to ensure clinical projects are conducted, recorded, and reported in accordance with the protocol, Company and Sponsor standard operating procedures (SOPs), ICH-GCP and/or all applicable local and federal regulatory requirements.

Key Responsibilities

• Performs on-site site qualification, site initiation, interim monitoring, site management activities and close-out visits ensuring regulatory, ICH-GCP and protocol compliance.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate.
• Assesses site processes.
• Conducts Source Document Review of appropriate site source documents and medical records.
• Verifies required clinical data entered in the case report form (CRF) is accurate and complete.
• Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines.
• Utilizes available hardware and software to support the effective conduct of the clinical project data review and capture.
• Verifies site compliance with electronic data capture requirements.
• Perform investigational product (IP) inventory, reconciliation and reviews storage and security.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan.
• Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
• For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met.
• Must be able to quickly adapt to changing priorities to achieve goals / targets.
• Prepares for and attends Investigator Meetings and/or sponsor in person meetings.
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.

Qualifications

• Minimum of 4 years of independent monitoring experience.
• Excellent oral and written communication skills in English, including proficient presentation skills required.
• Oncology and/or Endocrinology experience prioritized.
• Excellent communication, collaboration, and problem-solving skills.
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Demonstrate good computer skills and be able to embrace new technologies.
• Ability to manage required travel of up to 75% on a regular basis including by air, driving, etc.
• Bachelor's degree or RN in a related field or equivalent combination of education, training and experience.