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Clinical Research Associate I in South San Francisco, CA at Apex Life Sciences

Date Posted: 11/21/2018

Job Snapshot

Job Description

Role Purpose:                                                              

  • The U.S. Medical Affairs Sr. Clinical Study Associate (CSA) is responsible for providing operational support to multiple study teams through all phases of clinical study management (Plan, Start-up, Conduct, and Close-out) in accordance with appropriate quality standards including ICH/GCP and applicable regulations.

Major Responsibilities and Accountabilities:

  • Mentoring of junior level Clinical Study Associates
  • Communicate with internal team members and Contract Research Organizations (CROs) regarding trial start-up, maintenance, and close-out activities.
  • In collaboration with the Clinical Study Manager (CSM), assists in the oversight of vendor activities along with the CRO.
  • Oversight/support of some CRO activities, such as:
    • Receive regulatory documents for review and submission to the Regulatory Department. Develop Trial Master File (TMF) plan and manage through transfer of documents to the Sponsor
    • Provides guidance with development of the clinical trial binders for study sites. Manage and track study-specific payments and invoices.
    • Provide support for Investigator Meeting planning, including organizing meeting materials and provide on-site meeting assistance (as needed).
    • Oversee CRO tracking systems and tools to support the conduct of a clinical trial from the start-up to close-out phase.
  • Provides support to CSM on startup activities
  • Review and collaborate with CSM on the development of certain study specific plans and/or processes (e.g., Satellite Site Management Plans or Drug Destruction Memos)
  • Collaboratively work with CRO to ensure CTMS has current updated information.
  • Manage and track vendor-specific payments and invoices
  • Assist with maintaining tracking and reporting of study metrics. Coordinates with Clinical Study Manager (CSM) to communicate relevant trial information between various internal functional members and contract vendors.
  • Manage tracking and delivery of clinical/non-clinical supplies.
  • Generate and review trial management reports from internal tracking systems at requested intervals.
  • Conduct timely review of clinical trial documents upon request.
  • Review Informed Consent documents as well as Monitoring Visit Report Review (PSSV, SIV, IMV and COV).
  • Provide support to both internal and external departmental members when necessary.
  • May serve as subject matter expert on task forces, initiatives, and working groups.
  • Some travel may be required.

Key Capabilities:

  • Highly effective verbal and written communication skills; effectively delivers key messages; aptitude to independently communicate with teams and stakeholders.
  • Demonstrates an aptitude to distill information from multiple sources to create meaningful insights and induces collaboration and innovative thinking study-wide.
  • Experience with effective vendor management preferred.
  • Demonstrates an aptitude for strategic thinking skills; manages risks (including risk identification and mitigation); identifies critical path / critical dependencies.
  • Strong customer focus with functional peers, vendors, country affiliates, etc.
  • Excellent planning and organizational skills.
  • Ability to build trusting and collaborative relationships that promote innovation, knowledge-sharing and adaptation to change.
  • Practices the ability to influence and negotiate to achieve team goals.
  • Consistently supports change in an effort to continue to develop USMA’s dynamic organization.
  • Demonstrates creativity and innovation to support projects and initiatives.
  • Strong technical and analytical skills and ability to manage system data maintenance across multiple systems.
  • Aptitude to interpret outputs from analytical tools to enhance and improve study execution.
  • Self-motivated, achievement-driven and exhibits ability to work with minimal guidance.

Education and Experience:

  • Bachelor's degree or equivalent.
  • A minimum of 5 years in clinical research, or health related industry is required.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.