Clinical Trial Associate
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The Opportunity
Description
- Support study feasibility activities and perform database/web searches for sites as needed.
- Work closely with the Site Start Up (SSU) and ensure all study related regulatory and financial documents are collected and reviewed in support of study activation.
- Organize and maintain project working files and track critical documents. Report discrepancies to the appropriate clinical team member in a timely manner.
- Reconcile and transmit all essential documentation to CDIC as per Forest policy.
- Track and assist with processing site/vendor payments. Follow up on any issues as required.
- Collect and track patient enrollment information and update study management reports as necessary.
- Participate in testing of specifications and edit checks for internal (i.e. electronic data capture (EDC) and external (e.g. Interactive Voice/Web Response Systems (IVRS/IWRS), laboratory vendors) systems.
- Assist senior team members with in the planning, preparation, and on-site support of investigators meetings.
- Generate reports in various applications to assist the Clinical Scientist to perform clinical data review.
- Assist with ongoing data review and discuss comments with the clinical study team as needed.
- Assist with the preparation and distribution of meeting agendas and minutes. Actively participate in team meetings.
- Provide input and support in the development and distribution of monthly site newsletters.
- Support the Regional Site Managers by providing study related information and supplies, as requested.
- Communicate with IRBs and outside vendors to provide information and/or resolution to specific requests/issues.
- Support and correspond with sites to identify site specific needs (e.g. order and track study drug/other trial related supplies).
Our Client
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
- Associate degree or higher preferred
- 1-2 year relevant experience in pharmaceutical industry or CRO
- Experience supporting clinical trials preferred
- Basic knowledge of drug development and FDA GCP/ICH regulatory guidelines is a plus
- Proficiency with Microsoft Word, Microsoft PowerPoint, Microsoft Outlook, and Adobe Acrobat
- Strong skills with Microsoft Excel required
- Experience using electronic data capture (EDC) systems is a plus
- Oral and Written Communication
- Organizing
- Judgment and Problem Solving
- People Relationships
- Initiative and Accountability
- Ability to manage multiple tasks
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible?
