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Clinical Trial Associate

  • Location: California
  • Job Type:Contract

Posted 22 days ago

  • Expiry Date: 07 August 2021

Job Description:

Clinical Trial Associate (CTA)

  • SUMMARY: 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/EXPERIENCE/SKILLS:

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.

Knowledge/Skills/Abilities:

  • 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.

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.