Sr. Clinical Research Associate

JOB TITLE: Sr. Clinical Research Associate
DEPARTMENT: Clinical Operations
EMPLOYMENT TYPE: Full Time, Permanent
REPORTS TO: Clinical Study Manager/Sr. Clinical Study Manager
LOCATION: San Diego, CA

SUMMARY OF RESPONSIBILITIES:
The Senior Clinical Research Associate (Sr. CRA) focuses on execution of the day-to-day responsibilities associated with trial(s) planning and conduct as assigned by the Clinical Study Manager (CSM). This will include specific functional activities relating to the trial(s), sites, vendors, or other trial supportive activities in accordance with protocol, GCP regulations and ICH guidelines, and Standard Operating Procedures (SOPs). In addition, the Sr. CRA will participate processes improvement initiatives.

• Responsible for completion of assigned clinical trial activities from start up to closeout, in compliance with GCP/ICH regulations and guidelines, and applicable Aptose SOPs and Work Instructions. Supports the planning and operational logistics associated with Investigator and Safety Review Meetings.
• Responsible for site management activities, as applicable; site selection process including feasibility/site identification as requested, Investigational Product (IP) and clinical supplies chain of command oversight and processes, Informed Consent Form study specific content and site-specific review, trial(s) documentation completion, creation/reconciliation or oversight of study specific essential documents, responsible for oversight of study visits and review of monitoring trip reports, and managing and communicating the status of study progress and activities to Manager or above.
• Responsible for working with the CRA I/II and Clinical Trial Associate (CTA) to distribute and track clinical trial supplies; study medication, lab kits, and ensuring that sites have sufficient supplies for recruitment. Supports the Clinical Study Manager (CSM) or Clinical Operations Study Lead (COSL) with study reports and trackers.
• Responsible for vendor management activities, as applicable: primary study point of contact for assigned vendors, trial training of Clinical Research Organization (CRO) or other vendors, leads or participate in CRO and other vendor teleconferences, review of invoices and tracking of budget, and ensuring Trial Master File (TMF, electronic or paper) archival is complete and properly maintained and compliant with Good Documentation Practices, Aptose internal SOPs, and other applicable regulations. Develops and maintain an effective relationship with assigned external CROs and 3rd party vendor personnel.
• Identifies, investigates, and escalates to CSM/COSL discrepancies in study documentation (manuals, plans, protocol, instruction guides, trackers, worksheets, presentations, etc.) by applying clinical protocol and GCP knowledge and assists in the
• development of processes to mitigate reoccurrence throughout study phases. Supports and collaborates on other trial(s) activities such as: data management activities (data
• listings and protocol deviation review), lab samples & investigational product logs/trackers. Supports or oversee regulatory database (e.g., www.clinicaltrials.gov) updates by CRA II or delegate.
• Provides metrics and operational updates to support the clinical operations team and for reporting to senior management on clinical trial conduct. Ensures timely communication of relevant trial(s) information across team and escalation of urgent key information to the CSM/COSL.
• Supports or leads (if applicable) patient’s enrollment strategy for study execution on time and in compliance to clinical regulations and guidance, to ensure timely acquisition of study data by supporting activities related to query management and resolution, and data metric tracking.
• Leads and/or collaborates with other trial team members to ensure consistency and efficiencies across the trial team, and other in-house teams as assigned.
• Develops, maintains, and promotes a positive, effective, and collaborative working relationships with all team members while providing mentoring/coaching to CRAs I and II, and/or CTA.
• Identifies areas of best practice and process improvements, applying lessons learned within the trial. Participates as requested, in the development and maintenance of SOPs and/or initiatives and departmental coaching/mentoring for the development of clinical personnel.

• Master’s degree in Nursing, Health or Life Sciences and a minimum of 5 years related experience, OR Bachelor’s degree (similar fields) and a minimum of 8 years related experience
• Experience in Hematology/Oncology (preferably non-solid tumor) clinical trials are preferred with emphasis on Phases 1-3
• At least 3 years of biopharmaceutical clinical research as a CRA (preferred)

• Teamwork, creativity, adaptability
• Effective written and verbal communication
• Decision making, timely scalation, attention to details
• Solve problems and deadline-oriented
• Ability to plan and organize, and adapt
• Coordinate and participate in Investigator Meetings
• Collaborate with department members to identify process optimization/best practices and lessons learned within clinical operations
• Proficient in Microsoft Office (Word, Excel, Power Point, and Project)
• International Conference on Harmonization and Good Clinical Practice, and compliance
• Ability to work in a fast-paced environment with multiple competing tasks and demands, across various time-zones
• Demonstrated ability to work independently, take initiative, complete tasks to deadlines and support Clinical operations team in doing the same
• Demonstrated ability to present complex information to management

• Up to 50% as needed (Please note, due to COVID-19 travel is not required but is expected to be up to 50% when restrictions change and it is safe to do so.)