Summary of Position:
This position is responsible for coordinating biological sample management and investigator drug supplies across multiple clinical trials. Work will include oversight of third-party vendors, creating work instructions and operating procedures (internal and external), and executing bio-sample and investigational drug supply initiatives.
This individual will manage operational aspects of sample and drug shipments, track all bio-samples and investigational drug globally, and liaise with laboratories regarding sample analysis and drug depots as applicable. He/she will build relationships with vendors and act as a key resource for study teams, vendors, and clinical sites, as well as contribute to strategy for clinical drug supply and sample management. This individual will work across clinical study teams as well as cross-functionally to develop consistent practices.
Job Title: In-house Clinical Research Associate
Reports to: VP, Clinical Operations
Employment Type: Full-Time
Location: Raleigh/Durham, NC
FLSA Status: Exempt
Date: Spring, 2021
Required Skills & Abilities:
- Day-to-day oversight of global and local shipments of investigational drugs and biological samples. Manage sample operations to an audit-ready standard.
- Manage and prioritize daily workflow activities of third-party vendors supporting clinical study drug supply and bio-sample collection and processing.
- Identify risks in supply chain, recommend mitigation plans to management, and implement solutions. Ensure resources are in place to support clinical studies and supply chain projects.
- Develop and implement Standard Operating Procedures (SOPs) and work instructions that ensure full compliance with protocols in place.
- Manage multiple complex projects, business process development and technology and software deployments, improvements, and maintenance for all sample management systems.
- Take lead role in inventory reconciliation, returns, discrepancies, lost in transit shipments, complaints, recalls and closeouts.
- Represent sample operations at meetings for ongoing and prospective projects to establish and influence project strategies and deliverables related to samples.
- Manage milestones and timelines across projects, analyze and communicate project risks and issues as necessary. Adjust project plans, timelines or resources to ensure successful project delivery.
- Assist in contract processes in conjunction with Project Directors in providing correct scope of work for initial contracts and identifying changes in scope in ongoing projects.
- Provide sample reporting and on-demand support for third-party vendors and internal customers.
- Detail oriented and accurate
- Excellent organization and time management skills
- Excellent oral and written communication skills
- Ability to multi-task
- Excellent problem-solving skills with consistent demonstration of sound judgment required
- Experience managing business operations and/or processes very desirable
- Bachelor’s degree required
- A minimum of 5 years relevant pharmaceutical experience required.
- EDC and IRT experience required
- Experienced user of Microsoft Office applications (Word, Excel, PowerPoint, etc.) required
- Experience with GCP required; familiarity with GMP & GLP regulations desired
- Experience in biological sample management and/or clinical drug supply management preferred
- Experience with import/export regulations preferred
- Experience with packaging/ labeling of investigational drug supplies preferred
- Medical, Dental, Vision, 401(k)
Aravive, Inc. is an Affirmative Action/Equal Opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, protected veteran status, national origin, disability, sexual orientation, gender identity, marital status, genetic information or any other characteristic protected by law.
Company Overview: Aravive, Inc. is developing treatments designed to halt progression of life-threatening diseases, including cancer. Our approach draws on novel insights into targeting signaling pathways that drive the activation, migration and invasion of abnormal cells into healthy tissues. The company is based in Houston, Texas, and received support from the Cancer Prevention & Research Institute of Texas (CPRIT). For more information, please visit our website at https://aravive.wpengine.com.
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