Job Code: 2017-70-7
The Clinical Trial Associate (CTA) provides Clinical Operations Team members with project-specific support related to the conduct of clinical trials. The CTA will assist with clinical operation activities, including, but not limited to: creating and maintaining clinical study trackers/tools, drafting and distribution of meeting minutes, creating and maintaining trial master files, and reconciliation of study related documents/data. The CTA will provide general support to the clinical operations team. Works under supervision and reports to the Clinical Project Manager.
- Creates and maintains various clinical tools to track data including, but not limited to: study enrollment, study team contact lists, study team training, pharmacokinetic and lab data
- Maintains paper and/or electronic Trial Master Files. Collects and tracks incoming and outgoing clinical and regulatory documents. Ensures receipt, completeness, and accuracy
- Attends department and study related meetings. Drafts and distributes meeting minutes to the team
- Reconciles study specific documents and data received from sites, vendors, and/or the Clinical Research Organization (CRO)
- Coordinates distribution and shipment of study-related materials to clinical sites
- Communicates with sites, CRO personnel, vendors, and Clinical Research Associates
- Resolves administrative issues
- Assists with the creation of PowerPoint slides for activities such as Site Initiation Visit presentations, Investigator Meetings, and other study related team trainings.
- Complies with all applicable policies regarding health, safety, and environmental policies
- BS in healthcare or life sciences degree or related area and 1 -2 years of relevant experience or equivalent. Knowledge of clinical research terminology desired
- Strong computer literacy required (MS Word, MS Excel, and MS PowerPoint)
- Familiarity with FDA/ICH regulatory requirements for clinical trials is desired
- Outstanding organizational skills and detail oriented; ability to track detailed information
- Demonstrated communication skills, including verbal, written, and interpersonal skills
- Must be a team player and able to work under general direction
- Exhibits initiative
- Ability to appropriately handle confidential information
- Must be able to handle multiple tasks/assignments
GlycoMimetics, Inc. is an equal opportunity employer. To apply, please send your resume and cover letter to HR@glycomimetics.com and reference job number 2017-70-7 in the subject line.