The Senior Clinical Trial Associate, Clinical Operations, plays a key role in administratively supporting the planning, execution, and management of clinical trials within the organization. The Senior CTA works closely with the clinical operations team to ensure the successful implementation of clinical trials, adherence to regulatory guidelines, and the collection of high-quality data.

The Senior Clinical Trial Associate is a senior administrative role and will provide mentorship and guidance to the junior Clinical Trial Assistant role. The Senior Clinical Trial Associate will also support the development and review of Clinical Operations Department Administrative SOPs, Plans and System build. In addition, the Senior CTA will support the design and structure of the Admin framework and implementation of new processes or improvements to current process create processes not currently in place. The Senior Clinical Trial Associate may take ownership and manage sub-projects within the trial (ex: DEA Schedule I oversight at the site and central trial levels) and work closely with key consultants to drive the successful implementation and oversight of sub-projects. They will be the point of contact for all administrative needs for third-party vendors used within a trial and may have some oversight on monthly financial reporting and tracking.

Responsibilities:

• Establishes, performs quality control, maintains, and archives the Trial Master File (i.e., electronic folder set-up, filing, tracking, archiving) in compliance with DIA Reference Model, SOPs, ICH and GCPs. Ensures proper naming conventions are followed

• Assist with study start-up, including development of budgets, contracts, financial disclosure statements, and grant payments

• Coordinates distribution of documents and supplies/dosing room materials to sites and vendors/CRO as necessary

• Develops and maintains spreadsheets and other documents to track critical study milestones Tracks and reports on project or study information regarding subject and site status, metrics, lab sample shipments and discrepancies, and other parameters as appropriate

• Track and manage study-related documentation, including regulatory submissions, ethics committee approvals, and site contracts

• Prepares or assists with the preparation and review of study-related materials as it pertains to CTA processes (e.g., study reference manual, clinical trial material requests, and Investigator Site File)

• Organizes study information on the shared file drives

• Maintain trial Storyboard

• Lead and manage project-based assignments in support of clinical trials (ex: creating process documents and trackers; managing Schedule I activities)

• Design and create process/guidance documents for the Clinical Trial Assistant role-based tasks and responsibilities

• Assist in the writing and review of SOPs for the Clinical Operations department and support systems build out (ex: CTMS, eTMF, etc)

• Performs assigned administrative activities in a timely manner in support of clinical trials from design to completion

• Sets up and attends meetings, takes thorough meeting notes, and updates and distributes meeting minutes

• Organizes and helps plan meetings. May interact with meeting planners and travel agents

• Coordinates the distribution of communications to all sites (e.g., questionnaires, newsletters, mass mailings, IND safety reports, Investigator’s Brochures, etc.)

• Assists the Clinical Operations Trial Lead with tracking and processing of vendor or site invoices and ensures accurate accrual records are kept for the trials. Raise PO requests and request tax documents from vendors and consultants

• Maintains up-to-date knowledge of current regulations and guidelines to ensure compliance

• Provides general administrative support to the clinical team as assigned

• Processes forms, requests for information by the team, and requests to obtain information from vendors and investigative sites

• Provide guidance, mentorship, and daily oversight for more junior Clinical Trial Assistants assigned to specific clinical studies

• Responsible for obtaining license agreements for all ClinRo/PROs/scales and updating license holders as required per contract

REQUIREMENTS:

• Bachelor’s degree or equivalent combination of education/experience in science or health-related field

• Prior experience in clinical research, preferably as a Senior Clinical Trial Assistant or with at least 2 years in the Clinical Trial Assistant role

• Experience in Psychiatry and addiction medicine preferred

• Willingness and ability to travel up to 5-10% of the time, defined by business needs

• Working knowledge of GCP/ICH guidelines and the clinical development process, understanding of drug development from pre-IND through NDA

• Prior experience in development of tools and other tracking documents that support clinical research

• Prior experience with supporting study startup activities

• Strong communication skills with outside vendors and contractors

• Willing to maintain flexible work hours as needed and available during core business hours during critical periods of a trial

• Strong working knowledge of MS Project or Smartsheet and developing Gantt charts

• Advance knowledge of MS Excel/Google Sheets

• Excellent oral, written, and communication skills required

• Problem-solving and strategic planning skills

• Excited by innovative ideas in clinical research space; has a voice and provides meaningful contributions in meetings/calls

• Self-motivated, resourceful with getting the job done attitude in a fast-paced team environment

• Engaging, empathetic and dynamic personality; up for challenges and determined to find solutions

• This position requires strong organizational skills, attention to detail, and the ability to work effectively in a fast-paced and dynamic environment

$45,000 — $95,000/year