Asahi Kasei Therapeutics is the global specialty pharmaceutical business of Asahi Kasei. We are a commercial-stage company committed to positively impacting health by expanding therapeutic options that improve the lives of patients around the world. Drawing upon our strong heritage of scientific innovation, we aim to help reshape care in transplantation, nephrology, immunology, infectious diseases and other underserved conditions.
Job Description:The Clinical Research Associate (CRA) is a primarily in-house, sponsor-side Clinical Operations role responsible for supporting clinical trial execution through centralized site management, monitoring oversight, data review, document quality control, and study tracking. This position is expected to perform many non-travel responsibilities, including routine review of monitoring visit reports, Trial Master File (TMF) and investigator file maintenance, site communication follow-up, issue escalation, operational tracker maintenance, and support of inspection-readiness activities. The CRA partners closely with CRO monitors, clinical project managers, vendors, and cross-functional team members to help ensure clinical trials are conducted in accordance with the protocol, SOPs, Good Clinical Practice (GCP), ICH guidelines, and applicable regulatory requirements. Limited domestic or international travel may be required for investigator meetings, site engagement, or oversight activities, but the core responsibilities of the role are performed remotely or in-house.
The base compensation range for this role is $100-115K. Base Compensation is influenced by many factors including, but not limited to: time in the role, previous experience, skills, knowledge, performance, work requirements, internal equity, and business / economic conditions.
Summary of Key Responsibilities- Assist with all phases of clinical trial activities (start-up, maintenance, close out).
- Review site monitoring visit reports to identify potential site non-compliance and monitoring deficiencies and ensures sponsor oversight.
- Support the team in essential document review.
- Perform centralized review of clinical data listings, EDC queries, protocol deviations, site metrics, and study dashboards to support data quality, enrollment tracking, and timely issue resolution.
- Assist the Clinical Project Manager by monitoring the performance of the CRO's monitors.
- Assist with the oversight of site performance to ensure compliance with protocol, quality measures, and adherence to scope of work within timelines. Maintain tracking spreadsheets/databases, as required.
- Assist with filing and management of the Trial Master File (TMF). Review the investigator folders of the TMF on a regular basis to ensure all required documents have been submitted and are filed in accordance with the study TMF Plan.
- Provide proactive site interactions to encourage enrollment and study timeline compliance.
- Demonstrate independent site management capabilities (compliance, deliverables, relationship, and troubleshooting).
- Participate in trial meetings, such as kick-off, investigator, and monitor meetings, providing support as needed. May need to travel to site monitoring visits as necessary.
- Support tracking of operational study timelines and monitors operational performance metrics through the life of the study; supports issue resolution.
- Assist in the review of informed consents, case report forms, study operations manuals, monitoring tools, and other study-related materials.
- Track site level progress to ensure timely data collection, source document verification, and query resolution.
- Ensure timely safety reporting at assigned investigative sites.
- Participate in data listings review.
Required Qualifications and SkillsEducation/Training:
- Life science degree, advanced scientific, or clinical degree or equivalent degree or experience.
Previous Experience:
- At least 3 years' monitoring experience.
Abilities/Skills:
- Strong understanding of ICH GCP guidelines and region-specific regulatory guidelines (e.g., FDA, EMEA, PMDA, etc.).
- Ability to work with minimal supervision.
- Superior communication skills, both written and oral.
- Exceptional attention to detail and problem-solving skills.
- Flexibility to adapt to changing priorities and manage activities to meet the needs of the department while maintaining a focus on quality.
- Ability to take initiative, prioritize, and execute tasks and special projects with minimal direction or supervision, maintaining a high level of confidentiality, integrity, and discretion at all times.
- Ability to work effectively across different levels and functions.
- Ability to travel domestically and internationally, as required.
- Willingness to "roll up his/her sleeves" to get the job done.
- Proficient in MS Office Suite (Excel, Word, Outlook, PowerPoint).
Travel Requirements: Approximately 25%
#LI-AS1 #Hybrid
