Clinical Trial Associate Position Description
- The Contract Clinical Trial Associate provides clinical study administrative support and Trial Master File (TMF) support for clinical operations. The incumbent also provides support to clinical operations by reviewing vendor invoices for accuracy against budget, tracking vendor payments and taking meeting minutes during project team meetings.
- The incumbent works cross-functionally with internal departments and external resources on Clinical Development related issues.
- The Contract Clinical Trial Associate supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
- Assists with preparing and editing, tracking, and routing clinical development documents, e.g., clinical protocols, informed consents, etc., as requested.
- Assists with development and production of study materials, essential documents, presentations, reports, submissions, articles, and other materials; prepares clinical study conduct binders, track and file routine clinical study documents, either generated internally or received from Clinical Research Organizations (CROs), including, but not limited to: meeting agendas, minutes, status or patient trackers, patient screening logs and other documents as appropriate.
- Reviews vendor invoices for accuracy against budget.
- Liaises with Finance, or delegates, to ensure payments are made and tracked.
- Assists in preparation for regulatory audits or partnering discussion.
- Quality checks of clinical TMF documents, including clinical study site documents, email correspondence, training materials, and other study documents; generates filing indexes and maintains currents lists of correspondence.
- Provides appropriate administrative support, version control, and document tracking for SOPs, other documents maintained under Clinical Control.
- Performs other tasks and assignments as needed and specified by management.
- Bachelor's degree and minimum 5 years of Clinical Development/Operations support experience in a pharmaceutical, biotechnology, or related environment or a recognized equivalent of education and experience.
- Familiarity with clinical trial study documents.
- Knowledge of Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines.
- Proficiency with Microsoft Office Suite (MS Project, a plus).
- Excellent verbal and written communication and skills.
- Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
- Analytical thinker with excellent problem solving skills and the ability to adapt to changing priorities and deadlines.
- Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
- Experience with TMFs.
- Experience interacting with CROs.
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.