In-House Senior Clinical Research Associate
Aptose Biosciences is a science-driven biotechnology company advancing first-in-class agents to treat life-threatening cancers, such as acute myeloid leukemia (AML), high-risk myelodysplastic syndromes (MDS) and other hematologic malignancies.
Aptose Biosciences is seeking an In-House Senior Clinical Research Associate. The Clinical Operations Senior Clinical Research Associate (Sr. CRA) focuses on Clinical Operations Study execution responsibilities and may take a specified number of additional functional infrastructure activities.
The Sr. CRA will support and participate in the day-to-day Clinical Operations functional activities associated with the execution of clinical trials. This may include activities relating to sites in a specific country or region, third party vendors or other study supportive activities.
As a dedicated contributor to a departmental infrastructure area, a Sr. CRA will have responsibilities to sub-teams of the wider Clinical Operations group, such as Clinical Business Operations, eClincial, Resource Capacity Planning, Data Management, Outsourcing, Training, Quality, Standards, Processes and other initiatives. May also support department, development or cross-functional activities.
- Responsible for Clinical Operations site management activities, including but not limited to:
- Investigator recruitment/site selection process
- Investigational product (IP) package approval
- Informed Consent Form (ICF) Aptose template creation, and site specific ICF review and approval
- Clinical Trial supplies/materials and IP reconciliation
- Documentation reconciliation
- Monitoring trip report review
- Responsible for Clinical Operations vendor management activities, including, but not limited to:
- Function as the primary point of contact for various vendors
- Clinical Research Organization (CRO) or other vendors staff training
- Participate in CRO and other vendor teleconferences
- Invoice and budget review
- Ensure TMF is complete and properly maintained
- Assist in Clinical Operations data management activities
- Participate in data listing review, protocol deviation review, trend review
- Participate in co-monitoring of sites, including Pre-Study Visit, Site Initiation Visit, routine Site Monitoring visits and Close-Out Visit.
- Assist in the quality control of Clinical Operations documentation
- Apply knowledge of FDA regulations to site monitoring and clinical study design duties.
- Perform specialized tasks as trained in an independent fashion, requiring minimal ongoing direction.
- Assist in the development and review of study-related documents and tools (clinical study protocols, study plans, manuals, instruction guides, trackers, worksheets, presentations, etc.)
- Participate in Investigator Meetings.
- Mentor Clinical Assistants and Clinical Research Associate(s) I and II
- Assist team members with tasks that are outside normal work responsibilities, as needed
FUNCTIONAL INFRASTRUCTURE & ADDITIONAL RESPONSIBILITIES:
- Review and assist in the revision of department SOPs
- Collaborate with department members to identify process optimization / best practices and lessons learned within Clinical Operations
- Ensure compliance with Aptose SOPs and guidelines, FDA regulations, and current International Conference on Harmonization – Good Clinical Practices
REQUIRED EDUCATION & WORK EXPERIENCE:
- Master’s degree & a minimum of 3 years related experience, OR
- Bachelor’s degree & a minimum of 5 years related experience
- Master’s or Bachelor’s degree in nursing, health or life sciences field
- 7 years of Biopharmaceutical clinical research experience (working on clinical trials at a biotech, pharmaceutical or CRO)
- Clinical Research Certification
- Experience with Hematology/Oncology clinical trials
FUNCTIONAL / TECHNICAL KNOWLEDGE & SKILLS:
- Proficient in Microsoft Office (Outlook, Word, Excel, Power Point)
- International Conference on Harmonization – Good Clinical Practices
- Drug Development
- Trial Execution
- Regulatory Environment
- Communicate effectively in English, oral and written
- Delivery on commitments
- Maintain composure
- Proactively plan and organize
- Solve problems
- Be self-aware
- Detail oriented and meticulous follow through
- Up to 50%, as needed