Clinical Trial Associate

General Description:

- Role will support the study team with Clinical Operations tasks, and/or support compilation and quality of the trial master file (TMF)
- Demonstrates basic clinical operations knowledge and strong organizational skills
- Implements best practices and shares lessons learned with team and other colleagues, as appropriate
- Adheres to ICH/GCP, local regulations, SOPs and contributes to the development and/or review of Clinical Operations Work Instructions and SOPs
- The Junior Associate role in Clinical Operations is an entry level position

This job description provides the broadest description of potential assigned activities. There will be specific roles and responsibilities assigned from this Job Description, according to project assignment(s). As such, responsibilities will include some of the following activities, but may not be limited to:
Clinical Operations support to study teams:
Support cross-functional clinical study teams from start-up through close-out:

- Assists in development of clinical trial documents, manuals, trackers (may support informed consent development and version tracking)
- Preparation and documentation of internal and external meetings by preparing agendas and minutes
- Maintaining clinical operations tracking tools e.g.
- enrollment
- CTMS
- laboratory samples
- monitoring visits
- site status
- drug supply
- data cleaning
- vendor tracking
- training
- risk management
- study goals
- investigator contracts and payments; support study team with site level payments and invoices
- invoice reconciliation and budget tracking
- Support reporting for Senior Management updates
- Clinicaltrials.gov and/or local registry posting and maintenance
- Site materials and equipment: support study team with distribution of site materials and equipment, document printing, shipment, and other administrative work
- Administrative: business and department office administration support if required

Trial Master File (TMF)
- Preparation of TMF Plan and/or map
- Setup, maintenance and close out of TMF; coordinate on document collection, uploading into SharePoint (SP)/eTMF
- Ensure completeness and quality of TMF content for assigned clinical trials consistent with TMF specifications/plan, applicable SOPs, ICH/GCP guidelines and regulatory requirements; provide TMF/eTMF quality control (QC) if required
- Ensure the TMF is submission/inspection ready
- Be the primary point of contact for the TMF-related questions or issues
- Develop successful cross-functional relationships with internal and external TMF stakeholders
- Oversee documentation flow within projected timelines and determine course of action needed to prevent and remediate delays and errors with TMF compilation
- Primary point of contact for internal and external audits of study TMF-related queries and support the preparation of appropriate audit and inspection responses
- Effectively monitor and report on progress of the TMF to stakeholders
- Provide education, feedback and guide study teams to build knowledge and awareness of good document management practices for clinical trials
- Determine and review study specific TMF specifications to ensure quality and standardization is established per program and kept up to date as program/protocols progress
- Assess impact of potential changes to TMF specifications prior to implementation; collaborate with study lead or equivalent if modifications are necessary
- Guide Study Team in the effective management of TMF when working with external vendors

Mentoring Responsibilities:

- More senior members of the associate team may mentor junior associates
- Associates with experience in specific tasks may mentor other associates with less or no experience in these tasks

Project Management - Communicates changes and progress; Completes projects on time and budget.

Education Required:

- Bachelor’s degree (or equivalent) or higher in a scientific, medical, or healthcare discipline* with minimum of 2 years of experience in clinical operations (Senior Associate).
- Bachelor’s degree (or equivalent) or higher in a scientific, medical, or healthcare discipline* with minimum of 1 year of experience in clinical operations (Associate).
- Bachelor’s degree (or equivalent) or higher in a scientific, medical, or healthcare discipline* (Junior Associate). Entry level.

Computer Skills: Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook

Other Qualifications:

- Ability to work independently and effectively handle multiple priorities in a fast-paced environment
- Excellent interpersonal skills, strong organizational skills and effective written and verbal communication skills across all levels within an organization

Travel: up to15%

Competencies:
Ethics - Treat people with respect; Inspire the trust of others; Work with integrity and to high ethical standards; Uphold organizational values.

Planning/Organizing - Able to prioritize and plan work activities; Uses ti