[Hiring] Senior Clinical Trial Associate @Definium Therapeutics

Role Description

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. Responsibilities include:

• Support the development and review of Clinical Operations Department Administrative SOPs, Plans, and System build.
• Support the design and structure of the Admin framework and implementation of new processes or improvements to current processes.
• Manage sub-projects within the trial (e.g., DEA Schedule I oversight at the site and central trial levels).
• Act as the point of contact for all administrative needs for third-party vendors used within a trial.
• Oversee monthly financial reporting and tracking.

Principal Responsibilities:

• Establish, perform quality control, maintain, and archive the Trial Master File in compliance with DIA Reference Model, SOPs, ICH, and GCPs.
• Assist with study start-up, including development of budgets, contracts, financial disclosure statements, and grant payments.
• Coordinate distribution of documents and supplies/dosing room materials to sites and vendors/CRO as necessary.
• Develop and maintain spreadsheets and other documents to track critical study milestones.
• Track and report 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.
• Prepare or assist with the preparation and review of study-related materials as it pertains to CTA processes.
• Organize study information on the shared file drives.
• Maintain trial Storyboard.
• Lead and manage project-based assignments in support of clinical trials.
• 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.
• Perform assigned administrative activities in a timely manner in support of clinical trials from design to completion.
• Set up and attend meetings, take thorough meeting notes, and update and distribute meeting minutes.
• Organize and help plan meetings; may interact with meeting planners and travel agents.
• Coordinate the distribution of communications to all sites.
• Assist the Clinical Operations Trial Lead with tracking and processing of vendor or site invoices.
• Maintain up-to-date knowledge of current regulations and guidelines to ensure compliance.
• Provide general administrative support to the clinical team as assigned.
• Process 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.

Qualifications

• 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.
• Prior experience in development of tools and other tracking documents that support clinical research.
• 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.
• Advanced knowledge of MS Excel/Google Sheets.
• Excellent oral, written, and communication skills required.
• Problem-solving and strategic planning skills.
• Self-motivated, resourceful with a 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.

Requirements

• The starting base pay range for this position is $91,943.00 - $112,330.00.
• Compensation will be determined based on several factors including, but not limited to, skill set, years of experience, and the employee’s geographic location.
• Employees in this role may be entitled to additional compensation, including bonus and equity.

Benefits

• 100% paid health benefits including Medical, Dental, and Vision for you and your dependents.
• 401(k) program with company match and vesting after the turn of the first month after your start date.
• Flexible time off.
• Generous parental leave and some fun fringe perks!