Clinical Trial Assistant (CTA)

Clinical Trial Assistant (CTA)

Position Summary and Scope

The Clinical Trial Assistant provides support to the clinical operations department to assist 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.

The CTA is accountable for:

       Preparing, handling, distributing, files and archives, clinical documentation and reports

Independently maintaining the internal Trial Master File (TMF) in accordance with the DIA's reference model and periodically reviews the TMF(s) being maintained by the Contract Research Organization (CRO) to ensure accuracy, completeness and adherence to the DIA's reference model

Accurately updating and maintaining clinical systems within project timelines

Assisting, as directed, with taking and issuing meeting agendas and minutes for designated clinical team meetings

Assisting with processing vendor invoices in a timely and quality manner

Maintaining tracking information for study activities

Scheduling meetings with internal and external teams, as needed

Assisting with clinical data review

Assisting with the creation and/or review of project-specific tools, instructional manuals, protocols, and informed consents forms.

Assisting with review of site trip reports and ensure compliance with SOPs as well as identify protocol deviations

Assisting with study feasibility assessments for new protocols

Assist with set-up, evaluation and tracking of clinical laboratory vendors for each study

Participating in and support planning, conduct, management and completion of studies through interaction with sites, vendors and team members

Completing assigned responsibilities in a quality and timely manner

Performing administrative tasks to support team members with clinical trial execution, as needed

Assisting when needed with compiling regulatory submissions

Assisting Quality Assurance with administrative tasks as needed

All work must adhere to ICH Good Clinical Practice (GCP) guidelines and comply with the company's Standard Operating Procedures

Participating in continuous improvement initiatives and professional growth

Performing other related duties as required

Maintaining 100% compliance on all required department and company training

Adhering to pH Pharma’s values, applicable regulatory requirements, and company policies and procedures

Who You Are:

Successful candidate will have a minimum of 1 to 2 years relevant experience, to include experience in the pharmaceutical/biotech industry.

Strong communication skills (encompasses verbal, written, interpersonal, listening)

Effective time management and organizational skills

Attention to detail and accuracy in work

Ability to establish and maintain effective working relationships in a team environment

Positive, self-starter, flexible; ability to adapt to changing priorities

Basic understanding of medical and/or pharmaceutical industry, terminology, and practices

Working knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines

Computer skills including proficiency in use of MS Word, Excel, PowerPoint and Google Docs

Willingness to travel for job related activities if required (expected travel for this position is <20%)

Education / Experience:

BA/BS degree preferred.  Relevant experience will be considered.