Clinical Trial Assistant/Senior Clinical Trial Assistant

Job Description:

The Clinical Trial Assistant, Clinical Operations, has primary accountability at the trial level within the organization. The Clinical Trial Assistant will be accountable to help administratively manage, plan and scale clinical operations in support of the execution of our clinical research studies in the field of psychiatry, neuroscience, and/or addiction medicine (from the protocol concept through the clinical study report, ensuring completion of study deliverables). The Clinical Trial Assistant supports the efforts of Clinical Operations and performs a variety of administrative assignments under the guidance and direction of the Senior Clinical Trial Associate, Associate Director, or Director/Senior Director of Clinical Operations.

Responsibilities:

• Accountability as the SME for the CTMS system in house
• Submission/Document Tracking into CTMS
• Access Management
• Adding/updating study, country and site level milestone dates into CTMS
• Adding team members (internal + external)
• Accountability as the SME for the eTMF system in house
• Access Management
• Taking the eTMF Plan template and inserting study specific details (protocol, protocol #) and providing to CTM for review/updates
• Meeting with each department to talk through and update the eTMF index based on study needs
• Creating a package of placeholders based on the eTMF Index
• Sponsor QC of all documents uploaded by CRO
• Review and approval of all documents submitted by the CRO/vendors to the eTMF
• 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
• Accountable for oversight and tasks associated with maintaining inspection readiness
• Providing 1572s to Regulatory for submission
• Management and oversight of Internal Training
• Vendor Oversight and quarterly reviews and tracking
• Maintain Study Org Chart + Study Tracker for assigned clinical trials
• Work with team to decide Clin Ops SharePoint filing structure and then update our files to this structure
• Ensuring storyboards align between early and late phase
• Sets up and attends internal meetings, takes meeting notes, and updates and distributes meeting minutes
• Organizes and helps plan external meetings. May interact with meeting planners and travel agents
• Maintains up-to-date knowledge of current regulations and guidelines to ensure compliance
• Provides general administrative support to the clinical team as assigned
• Performs other duties as assigned

Requirements:

• At least 2 years of clinical trial experience in Pharmaceutical or Biotech company
• Bachelor’s degree or equivalent combination of education/experience in science or health-related field
• Experience in Psychiatry and addiction medicine preferred
• Working knowledge of GCP/ICH guidelines and the clinical development process, understanding of drug development from pre-IND through NDA
• Past experience in development of tools and other tracking documents that support clinical research
• Experience managing and working in CTMS and eTMF systems
• Strong working knowledge of MS Project and developing Gantt charts
• Advance knowledge of MS Excel
• Excellent oral, written, and communication skills required
• Problem-solving and strategic planning skills
• Excited by innovative ideas in clinical research space
• Self-motivated, resourceful with getting the job done attitude in a fast-paced team environment
• Engaging, empathetic and dynamic personality; ability to understand the problems of others and delight in finding solutions

The starting base pay range for this position is $53,032.00 - $98,800.00. 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 information is listed on our Jobs Page. The Company provides competitive benefits to employees including:

• 100% paid health benefits including Medical, Dental and Vision for you and your dependents
• 401(k) program with company match and immediate vesting
• Flexible time off
• Generous parental leave and some fun fringe perks!