- Expiry Date: 07 August 2021
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
Partners with other functions to track clinical samples
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
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
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
Bachelor’s degree, preferably in areas such as biological sciences, health care management or life
Typically requires a minimum of 1 to 2 years of related experience and/or combination of experience
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
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.