Job Title: Clinical Trial Associate

Job Summary

The Clinical Trial Associate (CTA) will provide in-house support for clinical trial operations including, but not limited to, interacting with the Contract Research Organizations (CROs) and clinical investigative sites, maintaining appropriate in-house trial documentation and providing general support for the clinical and regulatory activities of the company. Reports to the Manager, Clinical Operations.

Job Duties

• Provides support for clinical trial operations; help ensure that studies are completed on time and in compliance with SOPs, FDA regulations, and ICH/GCP
• Works closely with, site clinical research coordinators, and study staff to ensure smooth operation and documentation of trials under Good Clinical Practice (GCP) guidelines
• Supports the activities of planning, implementing , and tracking clinical trials including review and development of study documents and tracking tools
• Audits and tracks CRO activities related to clinical operations including site management, data management, and pharmacovigilance. Tracks the activities of the independent clinical monitoring staff
• Participates in various clinical operations meetings; takes minutes and distributes to team
• Assists in ensuring compliance with protocols, SOPs, GCP and FDA/ICH guidelines and overall clinical objectives through CRO/vendor oversight; to include but not limited to: written documentation of site visits, proper reporting of Adverse Events and appropriate follow-up, site performance, tracking study drug, as applicable, and other study-specific material shipments to/from sites
• Assists clinical team with coordination of trial site selection and study initiation, monitoring, and closure activities, in addition to investigator meetings and other trainings
• Participates in the review process of ongoing clinical trials
• Reviews site regulatory documents and maintains required study files (Trial Master File, etc.) in-house
• Complies with all applicable policies regarding health, safety, and environmental policies

Job Requirements

• BA/BS in life sciences or related area and at least 2 years of experience in clinical trial coordination (e.g. as study coordinator or site research coordinator)
• Demonstrated understanding and good use of judgment in application of regulations to clinical trial implementation and related areas
• Outstanding organizational skills and detail oriented; ability to track detailed information
• Familiar with FDA/ICH regulatory requirements for clinical trials
• Excellent communication skills, including presentation and writing skills
• Good interpersonal skills; ability to actively maintain good professional relationships with diplomacy and poise
• Strong problem solving skills; identifies issues and problems and discusses with the management team
• Proficiency in Microsoft Word and Excel, PowerPoint and Adobe Acrobat

GlycoMimetics, Inc. is an equal opportunity employer.
If this sounds like a great opportunity to you and you can offer experience, commitment, and enthusiasm, we would like to hear from you. Please send your resume and cover letter to HR@glycomimetics.com and indicate job code 2012-100 CTA in the subject line.