Senior Clinical Research Associate

DEPARTMENT: Clinical Operations
LOCATION: San Diego, California
EMPLOYMENT TYPE: Full Time, Permanent
REPORTS TO: Clinical Study Manager/Sr. Clinical Study Manager

SUMMARY OF RESPONSIBILITIES:

The Senior Clinical Research Associate (Sr. CRA) focuses on supporting and collaborating in the day-to-day responsibilities associated with trial planning and execution as assigned by the Clinical Study Manager. This may 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 may participate and/or lead processes across trials and process improvement initiatives.

RESPONSIBILITIES:

  • Accountable for completion of assigned clinical trial activities from trial start up to closeout, in compliance with GCP/ICH regulations and guidelines, and applicable Aptose SOPs and Work Instructions. Supports the development and operational logistics associated with Investigator Meetings.
  • Responsible for site management activities, as applicable; site selection process, Investigational product (IP) and clinical supplies processes, Informed Consent Form template creation and site-specific review and approval, trial documentation completion and reconciliation, and support and review of monitoring trip reports.
  • Responsible for vendor management activities, as applicable: primary 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) is complete and properly maintained.
  • Supports and collaborates on other trial activities such as: data management activities (data listings and protocol deviation review), monitoring activities (co-monitoring of sites, and review of reports), and development, maintenance and quality control of trial documentation (manuals, plans, protocol, instruction guides, trackers, worksheets, presentations, etc.).
  • Provides metrics and operational updates to support the operations team and for reporting to senior management on clinical trial conduct. Ensures communication of relevant trial information across trial team, timely communication and escalation of urgent information to the appropriate trial team leadership.
  • Supports or leads, if applicable, patient’s enrollment strategy to support completion of trial on time and in compliance to regulatory regulations and guidance. Manages and reports clinical investigational product and clinical supplies status; and ensure trial documentation is complete, up to date and in alignment with regulatory requirements.
  • Collaborates with other trial team members to ensure consistency and efficiencies across the trial team, and other in-house teams as assigned. Mentors/coaches CRAs I and II and Clinical Trial Associates.
  • Develops, maintains and promotes positive, effective and collaborative working relationships with team members and as applicable, with external CRO and 3rd party vendor personnel and co-development partner trial teams.
  • 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.

QUALIFICATIONS:

  • Master’s degree (prefer nursing, health, or life sciences field) and a minimum of 3 years related experience, OR Bachelor’s degree (similar fields) and a minimum of 5 years related experience
  • Experience in Hematology/Oncology (preferably non-solid tumor) clinical trials is preferred
  • 5 years of biopharmaceutical clinical research (preferred)

FUNCTIONAL / TECHNICAL KNOWLEDGE & SKILLS:

  • Teamwork, creativity, adaptability
  • Effective written and verbal communication
  • Solve problems, decision making, 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

TRAVEL REQUIREMENTS:

  • Up to 50% as needed

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Accepted formats: PDF, Word Doc

Accepted formats: PDF, Word Doc