Veloxis Pharmaceuticals is an Asahi-Kasei Group Company based in Cary, NC. Our purpose is to transform transplant medicine as the primary partner to the community of transplant healthcare providers and their patients; our focus is in developing new therapies and programs to help transplant healthcare providers and the patients they treat. Veloxis provides a dynamic and innovative place to work that encourages professional development and embraces diversity. We seek creative, intelligent, action-oriented, and passionate individuals who thrive in a collaborative team environment. If you are interested in being part of a patient-centric company, then we invite you to learn more about the employment opportunities available at Veloxis. Our success is tied to the contribution of every team member, which is why we provide a valuable and competitive compensation package that includes health and insurance benefits, training, and development opportunities, as well as performance-based bonus eligibility.
This role is primarily responsible for close interactive oversight of clinical research to ensure exceptional execution of clinical studies. The Sr. Clinical Research Associate (Sr. CRA) monitors clinical studies across geographic regions, in adherence to Good Clinical Practices (GCPs), appropriate Standard Operations Procedures (SOPs), regulatory authority guidance and directives, such as Food and Drug Administration (FDA), and International Conference on Harmonization (ICH) guidelines. The incumbent supports the interactions with CROs and other third-party vendors to ensure study milestones and deliverables are achieved according to agreed quality standards and timelines so that data is suitable for regulatory submissions and publications. The incumbent escalates site-level issues and assists in troubleshooting routine site inquiries, as well as helps to ensure clinical study participant safety and provide high quality data review and reporting in compliance with SOPs, GCP, and ICH guidelines.
- Assists the Clinical Project Manager by monitoring clinical trial performance and quality metrics.
- Responsible for the oversight of site performance to ensure compliance with protocol, quality measures, and adherence to scope of work within timelines.
- Triages, resolves, or escalates study issues / risk mitigations. Provides proactive site interactions to encourage enrollment and study timeline compliance.
- Supports and maintains metrics-based tools to assess departmental and third-party performance to meet corporate goals.
- Ensures adherence to internal procedures for study planning, study conduct, close-out, and reporting.
- Demonstrates independent site management capabilities (compliance, deliverables, relationship, and troubleshooting).
- Collaborates with Clinical Operations team to ensure a study is always audit/inspection ready. Addresses any findings from audits/inspections in a timely and appropriate manner. Participates in site audits, as requested.
- Participates in trial meetings, such as kick-off, investigator, and monitor meetings, providing support as needed.
- Supports tracking of operational study timelines and monitors operational performance metrics through the life of the study; supports issue resolution.
- Assists in the creation and review of informed consents, case report forms, study operations manuals, monitoring tools, and other study-related materials.
- Tracks site-level progress to ensure timely data collection, source document verification, and query resolution.
- Reviews site monitoring visit reports to identify potential site non-compliance and monitoring deficiencies and ensures sponsor oversight.
- Accountable for co-monitoring visits to demonstrate CRO oversight and assists with any source document verification backlog.
- Ensures timely safety reporting at assigned investigative sites.
- Participates in data listings review.
Required skills and qualifications
- BS / MS in a life sciences discipline or demonstrated knowledge.
- At least 5 years’ relevant clinical research experience, including onsite monitoring experience in the pharmaceutical or CRO industries.
- Strong understanding of ICH, GDP, and relevant regulatory requirements.
- Ability to work with minimal supervision.
- Superior communication skills, both written and oral.
- Exceptional problem-solving skills, with attention to detail.
- Flexibility to adapt to changing priorities and manage activities to meet the needs of the department while maintaining a focus on quality.
- Ability to work effectively across different levels and functions.
- Expert computer proficiency: MS Office Suite.
- Travel Requirements: Approximately 25%.