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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.
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