15 Jul
Clinical Trial Associate (Remote)
California, Brisbane , 94005 Brisbane USA

Vacancy expired!

CLINICAL TRIAL ASSOCIATE (REMOTE)BRISBANE, CAProject Description: Provides support to the clinical operations function with execution and maintenance of clinical studies. Acts as a central support for the clinical team for designated project communications, correspondence, and associated documentation. Maintains, updates, and may establish various databases for clinical activity tracking. Processes, logs and distributes completed case report forms. Tracks incoming and outgoing clinical and regulatory documents and updates for investigator sites.Essential Duties and Responsibilities:

  • Scope of studies
    • May support one or more studies.
  • Study level planning and oversight
    • Set up and maintains Trial Master File (TMF).
    • Responsible for clinical team meeting scheduling, agendas and minutes.
    • Schedules meeting with internal and external teams as needed.
    • Accurately updates clinical systems with milestones within project timelines.
    • Maintains trackers as needed.
  • Vendor oversight
    • Partners with other functions to track clinical samples.
  • Site management
    • Contributes to study manual development.
    • Supports sample tracking and reconciliation.
    • Supports clinical trial supply requisition and maintain tracking.
    • May conduct Informed Consent Form (ICF) review.
    • May participate in clinical data reviews.
    • Collects and collates feasibility data.
  • Relationship and stakeholder management
    • Team oriented, solid communicator
  • Clinical documents
    • Prepares, handles, distributes, files and archives clinical documentation and reports.
    • Review of regulatory submission documents with Clinical Trial Manager oversight.
  • Negotiating and influencing
    • Aware of key business partners.
  • Business and therapeutic knowledge
    • Understands the organization, key business partners.
  • Inspection readiness
    • Manages internal TMF and perform audits as needed for internal and Contract Research Organization (CRO) TMFs to ensure quality and completeness adhering to DIA model.
  • Ability to travel.
    • On occasion
Education:
  • Bachelor's degree, preferably in areas such as biological sciences, health care management or life sciences research.
Experience:
  • Typically requires a minimum of 1 to 2 years of related experience and/or combination of experience and education/training.
  • Understanding of the Trial Master File structure (TMF), preferred.
  • Highly proficient in software applications such as Word, Excel, and PowerPoint.
  • Good written and verbal communication skills and proven ability to multitask. Efficient time management and organizational skills. Attention to detail and accuracy in work.
  • Has a basic understanding of the drug development process and knowledge of FDA regulations and guidelines.
Required Skills:
  • Organizes and prioritizes numerous tasks and completes them under time constraints.
  • Applies technical standards, principles, theories, concepts and techniques.
  • Demonstrated success in problem solving.
  • Experienced professional with a full understanding of area of specialization.
  • Applies strong analytical and business communication skills.
  • Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
  • Develops relationships with senior internal and external personnel in area of expertise.
Values:
  • Patients first
  • Passion for science
  • Succeed together.
  • Imagine and innovate.
  • Lifelong learning
This 6+ month position starts ASAP.Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: ALPHA'S REQUIREMENT #21-02288MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE#ZR#LI-BB1

Vacancy expired!


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